Interventional procedure overview of direct skeletal fixation of limb prostheses using an intraosseous transcutaneous implant
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Evidence summary
Population and studies description
This interventional procedures overview is based on 2,708 people from 1 HTA, 3 systematic reviews, 2 retrospective cohort studies, 2 retrospective reviews, and 1 cross-sectional observational study. Of these 2,708 people, 2,606 had the procedure. This is a rapid review of the literature, and a flow chart of the complete selection process is shown in figure 1. This overview presents 8 studies as the key evidence in table 2 and table 3, and lists 68 other relevant studies in table 5. There is an overlap of studies between the HTA and systematic reviews.
The HTA assessed 2 stage OIP implant surgery for people with an amputation above the knee who had problems with socket prosthesis or cannot use a socket, in 9 observational studies (4 retrospective and 5 prospective) with short-term follow up (mean 1 to 5 years). One study reported follow up of 7.5 years. The population sizes ranged from 12 to 96 people. Studies were based in Sweden, the Netherlands, Germany, and Australia. No studies comparing DSF with conventional or no prosthesis were identified in the review. Studies evaluated 3 implants that are used currently (OPRA implant system in 4, ESKA EEFP/ILP in 3, and OGAP-OPL in 1, ILP or OGAP-OPL in 1). All studies reported exclusion criteria and excluded people with peripheral vascular disease and diabetes mellitus, exposure to radiation in the affected limb or past or ongoing chemotherapy. Amputations were mainly due to trauma or tumours. 7 studies included some people with bilateral amputations and the results were analysed separately. 2 studies included only people with unilateral amputations and 1 only on people with bilateral amputations. All the studies included in the HTA were at high risk of bias (when assessed using the ROBINS-I instrument) and certainty about the evidence for functional outcomes and QOL reported was very low when assessed using modified GRADE. Some studies had overlapping patient data. A qualitative synthesis of the included studies was done to summarise outcomes. Authors state that 'it was not clear if problems with sockets and suitability for surgery were assessed in a standard and reliable manner in included studies and whether the studies included all people after being unable to tolerate socket prostheses'.
A systematic review (Atallah 2018) of 12 cohort studies only assessed safety data on BAP (3 types of prostheses) for people with an extremity amputation. A qualitative synthesis of the included studies was done to summarise outcomes. There was a partial overlap of patient data in some of the included studies. Data was analysed separately according to the implant type and level of amputation. Some studies were retrospective and may have underestimated the complication rates.
Another systematic review (Balzani 2020) included 17 case series with several types of implants and varied follow-up times. Amputation at different levels were analysed.
A large prospective cohort study (Hagberg 2020 with OPRA implant and a rehabilitation protocol) was conducted over 18 years in a single centre and reported results for multiple timepoints (2, 5, 7, 10 and 15 years). People were recruited at different times throughout the study and only small number of people had 15-year follow up. There were insufficient details about the criteria for defining problems related to socket-suspended prosthesis. People were excluded from the study due to death (n=3), lost to follow up (n=6) and implant failures (n=18).
A small retrospective study (Thouvenin 2023 with OPRA implant) with long-term follow up (average 9.4 to 15 years) compared outcomes before and after the procedure.
Two retrospective studies (Hollewarth 2020 and Örgel 2022 both with ILP) focused only on management of periprosthetic fractures.
All the included observational studies in the overview were at high risk of bias and certainty about the evidence for all outcomes was very low.
Table 2 presents study details.
Study no. | First author, date country | Patients (male: female) | Age | Study design | Inclusion criteria | Intervention | Follow up |
|---|---|---|---|---|---|---|---|
1 | Ontario, 2019 Canada | N=480 (68.8%:31.2%) | Mean age= 65.7 years | Systematic review and HTA (9 studies for qualitative synthesis and 0 for quantitative synthesis) | Adults with lower-limb amputation due to nonvascular causes who have problems with the use of socket prosthesis or cannot use a conventional socket prosthesis | 1. OPRA Implant System, Integrum AB, Sweden 2. EEFP, ESKA Orthopaedic, Germany; also known as ILP 3. OGAP-OPL, Permedica, Italy | Mean/median duration= 1 to 5 years among most studies (one study had a follow up of 7.5 years but only reported on the risk of osteomyelitis) |
2 | Atallah, 2018 8 different centres worldwide | N=604 (640 implants, 537 people with a lower- and 67 people with an upper-limb amputation) (426:147) TFA, n=522 TTA, n=15 THA, n=40 TRA, n=14 Thumb amputation, n=13 | Mean age= 45, 47 and 48 years in people with a screw, press-fit or Compress implant | Systematic review (12 cohort studies for qualitative synthesis, 3 prospective, 6 retrospective and 3 undefined design) Of these, 3 studies had 2 separate cohorts based on level of amputation or implant type So, a total of 15 cohorts assessed | RCTs, controlled clinical trials and prospective and retrospective observational studies (including before-after, cohort and case-control studies) reporting device- or procedure-related complications in people with an upper or lower (or both) extremity amputation (mainly trauma) treated with bone-anchored prostheses | OPRA screw (n=206), ILP or OGAP-OPL press-fit (n=387) or other type of bone-anchored implant (Compress implant, n=11) | Varied follow-up time points (ranged from 1 to 288 months) |
3 | Balzani 2020 Italy | N=634 patients (669 implants) TFA, n=586 TTA, n=6 THA, n=37 TRA/TUA, n=24 Thumb or partial amputation, n=12. | Mean age = 44.7 years (range 17 to 84 years) | Systematic review (17 studies for quantitative synthesis) | Studies with upper and lower-limb amputation (major cause trauma in 65%) treated with an osseointegrated prosthesis, with description of procedure, reporting clinical outcome and complications | Osseointegrated prosthetic implants for limb amputation (OPRA implant system in 10 studies, OGAP-OPL in 3 studies, not reported in 1 study, customised 3- dimensional printed titanium implant [AQ Implants] in 1 study and EEFP in 2 studies) | Average 61.4 months, ranging from 10 months to 228 months |
4 | Leijendekkers RA 2017 The Netherlands | N=227 patients with TFA mainly due to trauma (110 BAP in cohort studies, 32 BAP versus 185 socket prosthesis in cross-sectional studies) | Cohort studies ranged from 20 to 70 years; cross-sectional studies: BAP group ranged from 26 to 67 years, socket-prosthesis group ranged from 28 to 70 years | Systematic review of 7 studies (5 before and after cohort and 2 cross-sectional studies) conducted in Sweden (n =6) and the Netherlands (n = 1) | Studies on patients with a lower extremity BAP; comparing bone-anchored prostheses with socket prostheses; evaluating QOL, function, activity or participation level. studies in English, Dutch or German | Bone-anchored prostheses compared with socket prostheses | Varied follow up across studies. |
5 | Hagberg 2020 Europe | N=111 (78:33) | Mean age= 44.6 years (range 17 to 70) | Prospective cohort study | People with unilateral TFA (mainly trauma) experiencing problems related to a socket-suspended prosthesis and having mature and sufficient residual skeleton dimensions were enrolled | Bone-anchored transcutaneous prosthesis -OPRA implant system surgery in 2 stages followed by a rehabilitation protocol | 18 years Results reported at multiple time points (2 to 15 years) At 15 years (n=14) |
6 | Thouvenin 2023 France | N=17 (20 BAPs) (7:10) 3 bilateral amputees Level of amputation: TFA 14, TTA 3 Time between amputation and surgery 8.4 years. | Mean age=32 years (range 15 to 54) | Retrospective cohort study (single centre) | People with lower-limb amputation (mainly due to trauma) eligible for a BAP (between 2007-2021) if they major fitting difficulties with a socket-suspended prosthesis, such as a short stump, skin lesion in the socket, or intractable pain, and more than 1 year follow up | OPRA implant system | 1 to 15 years |
7 | Hollewarth 2020 | N=458 (519 OIP) Upper extremity (n=17, 18 implants, Humerus 16 implants radial 1 implant) Lower extremity (n=441, 500 implants, Femur 347 implants and tibia 153 implants) Bilateral procedures femur 34, tibia 16, humerus 1 | Mean age (SD, range) = 48.3 years (13.1; 22.6 to 64.5) | Retrospective review | All osseointegration operations done at 4 centres between 2010 and 2018 | Osseointegrated Prosthetic Limb/ILP devices | Not reported |
8 | Örgel 2022 Germany | N=140 (2 centres) | Mean age 48.7 years | Retrospective cohort study | Patients treated with TOPS following TFA between 2010-2019 | EEP/ILP device | Not reported |
9 | Welke 2023 | N=37 (20 BAP and 17 socket suspended) | BAP group: Mean age (SD) = 54 (8.2) Socket group: Mean age (SD) = 62 (14.6) | Cross-sectional observational study | Adults with unilateral TFA, mobility grade 3 'unrestricted outdoor walker' or 4 'unrestricted outdoor walker with particularly high demands' and initial prosthetic fitting that has been completed for more than 2 years | Socket fitting or BAP system | Not reported |
First author, date | Efficacy outcomes | Safety outcomes |
Ontario, 2019 Canada | Functional Outcomes and HRQOL 6MWT Score in metres, mean (SD); 2 studies van de Meent 2013 (n=22 TFA, device ILP) preoperative: 321 m (28), 1-year follow up=423 m (21); p=0.002 Al Muderis 2016 (n=50 TFA, device: ILP and OGAP-OPL) Wheelchair user, preoperative: not reported, mean 1.8-year follow up: 411 (31.44); p=not reported Prosthesis user, preoperative: 281 m (93), postoperative= 419 m (133); p<0.001 TUG score in seconds, mean (SD); 2 studies van de Meent 2013 (ILP) preoperative: 15.1 (2.1), 1-year follow up= 8.1 (0.7); p=0.002 Al Muderis 2016 (ILP and OGAP-OPL) Wheelchair user, preoperative: not reported, mean 1.8-year follow up= 9.0 (0.56); p = not reported Prosthesis user, preoperative: 14.59 (5.94), postoperative: 8.74 (2.81); p<0.01 AMP No studies reported on AMP. However, 1 study (Al Muderis 2016) reported on K-levels based on previously reported AMP scores; K-level improved in 60% of people and was unchanged in 40% (p=0.001) ROM None of the studies reported on changes in ROM Q-TFA; 3 studies Brånemark 2014 (n=51 TFA, 55 implants, device: OPRA implant system) Daily prosthesis use increased from 57% before the procedure to 89% at 2 years follow up. Van de Meent 2013 (ILP) Prosthetic use: preoperative 56 hours per week, at 1-year follow up 101 hours per week, p<0.001 Global health score: preoperative 39 (4.7), at 1-year follow up 63 (5.3), p=0.001 Al Muderis 2016 (ILP and OGAP-OPL) Only reported scores for global health, which showed a statistically significant improvement (preoperative 47.82, at mean 1.8-year follow up 83.52, p<0.001) SF-36; 2 studies Brånemark 2014 (OPRA implant system, 2- and 5-years follow up) Physical functioning: baseline 35 (0 to 85), change 23 (−23 to 75; n=45); p<0.001 5 years: 28 (23.1; n=40), p<0.0001 Role-physical: baseline 41 (0 to 100), change 22 (−50 to 100; n=44); p<0.001 5 years: 19 (47.9; n=39), p=0.02 Bodily pain: baseline 55 (10 to 100), change 6 (−61 to 59; n=45), p=NS 5 years: 4 (30.7; n=40), p=0.45 General health: baseline 78 (37 to 100), change −1 (−42 to 40; n=45); p=NS 5 years: 3 (22.7; n=40), p=0.31 Vitality: baseline 60 (15 to 90), change 3 (−70 to 45; n=45); p=NS 5 years: 3 (22.1; n=40), p=0.35 Social functioning: baseline 78 (13 to 100), change 1 (−100 to 63; n=45); p=NS 5 years: 1 (31.8; n=40), p=0.96 Role-emotional: baseline 75 (0 to 100), change 0 (0 to 100; n=44); p=NS 5 years: −1 (42.9; n=39), p=1.00 Mental health: baseline 74 (4 to 100), change 2 (−76 to 40; n=45); p=NS 5 years: 1 (22.2; n=40), p=0.56 PCS: baseline 74 (4 to 100), change 2 (−76 to 40; n=44); p<0.001 5 years: 10 (9.9; n=39), p<0.0001 MCS: baseline 53 (19 to 69), change −3 (−44 to 22; n=44); p=NS. 5 years: 4 (14.4; n=39), p=0.22 Al Muderis 2016 (ILP and OGAP-OPL) PCS: baseline 37.09 (9.54), 1.8-year follow up 47.29 (9.33), p<0.001 | Superficial infection Brånemark 2014 (OPRA implant system, 2 years follow up): 55% (28 out of 51), incidence=41 episodes. Treated with antibiotics. 5 years follow up: 67% (34 out of 51), 70 episodes; treated with antibiotics, 1 implant loosening and explantation. Juhnke 2015 (ILP, n=39 TFA, mean follow up 2.7 years): none. Al Muderis 2016 (ILP, mean 2.8 years follow up): mild 27% (23 out of 86), severe 1% (1 out of 86), 43 episodes, treated with antibiotics. Al Muderis 2016 (ILP and OGAP-OPL, mean 1.8 years follow up): total 36% (18 out of 50; [mild 26% (13 out of 50) and severe 10% (5 out of 50)]). Refashioning surgery=20% Al Muderis 2017 (OGAP-OPL, mean 1.2 years follow up): 45.5% (10 out of 22). Refashioning surgery=27% Deep or bone infections Tillander 2010 (OPRA implant system, n=39 [TFA 32, TTA1, arm 6], mean 3 years follow up): 18% (6 out of 39) occurred at mean 2.8 years. Surgical reintervention, n=4 (2 revision, 1 debridement, and 1 extraction). Brånemark 2014 (OPRA implant system, 2 years follow up): signs of infection=4% (2 out of 51), positive culture 4% (2 out of 51), occurred immediately after stage-1 to 42 days after stage-2. 5 years follow up: 22% (11 out of 51), mainly treated with antibiotics, led to 1 implant loosening which was removed 6 months after stage 2 surgery. Tillander 2017 (OPRA implant system, n=96 TFA, mean follow up 7.9 years): Osteomyelitis [occurred at median 2.6 years]: overall 17% (16 out of 96), before OPRA protocol 26% (7 out of 27), during and after OPRA protocol 13% (9 out of 69). Extracted 10 and reimplanted 1. Osteitis [diagnosed more than 5 years after implantation]: 6% (6 out of 96). Al Muderis 2016 (ILP, mean 2.8 years follow up): abscess formation 5% (4 out of 86). Surgical debridement in all. Al Muderis 2016 (ILP and OGAP-OPL, mean 1.8 years follow up): 6% (3 out of 50). Surgical debridement in all. Bone fracture Brånemark 2014 (OPRA implant system, 2 years follow up): femoral fracture, 0. other locations, ipsilateral hip= 6% (3 out of 51), below elbow= 2% (1 out of 51) and vertebral compression fracture= 2% (1 out of 51). Juhnke 2015 (ILP for TFA, mean 2.7 years follow up): femoral fracture, 5% (2 out of 39). Other locations not reported. Al Muderis 2016 (ILP, mean 2.8 years follow up): femoral fracture, 3.5% (3 out of 86). Other locations not reported. Al Muderis 2016 (ILP and OGAP-OPL, mean 1.8 years follow up): Femoral fracture, 8% (4 out of 50) Other locations not reported Implant removal Tillander 2010 (OPRA implant system, mean 3 years follow up): 3% (1 out of 69). Reason = deep infection Brånemark 2014 (OPRA implant system, 2 years follow up): 5.8% (3 out of 51). Reason = deep infection: 1 at 6 months and failed integration: 2 at 1.3 and 1.7 months 5 years: 4 implants removed, 3 needed stump revision Implant survival rate 92%; revision-free survival rate was 45% Juhnke 2015 (ILP, mean 2.7 years follow up): 2.6% (1 out of 39). Reason = failed integration Al Muderis 2016 (ILP, mean 2.8 years follow up): 3.5% (3 out of 86). Reason = failed integration in 1, breakage of implant in 2 at 42 and 47 months after stage 1 Al Muderis 2016 (ILP and OGAP-OPL, mean 1.8 years follow up): 4% (2 out of 50). Reason = failed integration at 2 years (n=1) and fatigue failure 3.5 years (n=1) Intramedullary breakage and extramedullary mechanical issues Brånemark 2014 (OPRA implant system, 2 years follow up): Implant breakage, 0 5-year follow up: 43 mechanical complications in 15 people, needed replacement of damaged parts Issues with extramedullary parts: changing the abutment or its screws: 8% (4 out of 51; 9 events; 6 occurred in 1 patient) Al Muderis 2016 (ILP, mean 2.8 years follow up) Implant breakage, 2.3% (2 out of 86). issues with extramedullary parts: breakage of safety parts: 29% (25 out of 86; 30 events). Juhnke 2015 (ILP, mean 2.7 years follow up) 0 events Non-infectious soft-tissue and bone complications Juhnke 2015 (ILP for TFA, mean 2.7 years follow up) Excess granulation tissue at stoma: 1. Treatment= removed granulations Al Muderis 2016 (ILP, median 2.8 years follow up)
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Atallah, 2018 | No clinical efficacy results assessed | Infection reported in 73% (11 out of 15) cohorts Overall infection rate (implant type): 23% to 49% (with screw implants), 0% to 77% (with press-fit implant) and 0% (with Compress implant) Soft-tissue infections in the skin-penetrating area (grade 1 to 2): 28% (screw implants) and 0% to 57% (press-fit implants) Bone infection (grade 3): 5% to 13% (screw implants) and 0% (press-fit implants) Infections resulting in implant loosening (grade 4): 8% to 11% (screw implants) and 3% to 29% (press-fit implants) Infection rates in relation to amputation level: 0% to 77% (TFA treated with press-fit implants) and 44% (upper extremity amputation). Rates unknown for TTA Rate of soft-tissue infections (grade 1 to 2): 0% to 57% (TFA treated with press-fit implants) and 28% (upper extremity amputation) Bone infection (grade 3): 13% (TFA treated with screw implants) and 6% (upper extremity amputation) Implant loosening due to infection (grade 4): 0% to 11% of people with TFA (screw-fit: 11%, press-fit: 0% to 3%), 29% (TTA) and 11% (upper extremity amputation- all trans-humeral) Juhnke 2015. infection rates: from 77% to 0% before and after adaptation of surgical technique and implant designing press-fit transfemoral implants Soft-tissue complications Lower-extremity amputation-TFA Stoma hypergranulation: 44% (in those with screw implant), 3% to 20% (with press-fit implants) and 0% (with Compress implant) Stoma-redundant tissue: 0% (with screw implant), 3% to 16% (with press-fit implant) and 9% (with Compress implant) upper extremity amputation: stoma hypergranulation of 44% in people with THA treated with screw implants (in 1 study) TTA: 0% Periprosthetic bone fracture reported in 60% (9 out of 15) cohorts 0% (in studies with screw implant), 0% to 10% (in 7 studies with TFA treated with press-fit implant) and 18% (in 1 study with TFA treated with Compress implant). 0% in studies with upper extremity implants and in those with implants for TTA Cause of bone fracture: falls (reported in 3 studies) Device Breakage (fractures of the intramedullary implant, of the abutment [screw] and of the dual-cone adaptor [press-fit])reportedin 53% (8 out of 15) of the cohorts Implant type: 27% to 45% (with screw -fit implant), 0% to 31% (with press-fit implants) and 0% (with Compress implant) amputation level: Intramedullary device breakages: 0% (TFA treated with screw implants), 1% (TFA treated with press-fit implants) and 27% (transradial screw implants). No breakages in those with implants for TTA Implant Loosening reported in 60% (9 out of 15) cohorts. Implant type: 3% to 23% (in 2 studies with screw implants), 0% to 29% (in 4 studies with press-fit implants) and 0% (in 1 study with Compress implant) amputation level: loosening occurred in 0% to 3% of people with TFA treated with press-fit implants, 29% of people with TTA treated with press-fit implants, in 13% and 23% of people with trans-humeral and thumb amputation and 0% in those with TRA Complication-related interventions Surgical revision (for stoma-redundant tissue, infection and hypergranulation) Implant type 11% (in those with a screw implant), 9% (in those with Compress implant) and 6% to 77% (in those with press-fit implants). Explantation (for infection, device breakage, bone fracture, and implant loosening) Implant type Incidence:14% to 19% (in 5 studies with screw implant), 0% to 57% (in 8 studies with press-fit implant) and 9% (in 1 study with Compress implant) Explantation rate as per level of amputation: TFA: 17% to 18% (screw implant), 0% to 13% (press-fit implant) and 9% (Compress implant) TTA: from 42% to 57% (press-fit implants) THA: 17% to 19% (screw implants) Reimplantation reported in 87% (13 out of 15) cohorts Implant type: performed in 6% to 40% (in 4 studies with screw implant), 25% to 100% (in 8 studies with press-fit implant) and 100% (in 1 study with Compress implant) Reimplantation was successful in 33% of people with THA |
Balzani 2020 | Lower limb SF-36: MCS postoperative mean value 55.1 PCS postoperative mean value 45.4 Muderis (2016): PCS (p=0.001) Brånemark (2014): general QOL (p<0.0001) Atallah (2017): MCS: 57.4 (range 41.2 to 70.3); PCS: 40.8 (range 38.9 to 44.4) Hagberg (2008): MCS: 50; PCS: 44 Hagberg (2014): PF: 60 ± 21,4; PCS: 40.5 ± 9.8 Matthews (2019): improved significantly between preoperative and 2- and 5-years follow up McMenemy (2020): MCS: 58.19; PCS: 54.5 Al Muderis (2016): PCS: mean 47.29 (SD 9.33) Q-TFA: postoperative mean value of 73.8 Muderis (2016): Significant improvement in Q-TFA global score (p=0.001) Brånemark (2014): Q-TFA scores improved (p<0.0001): prosthetic use, prosthetic mobility, global situation, and fewer problems Atallah (2017): global: 63.2 (58 to 83.3) Hagberg (2008): global: 72.1 (33 to 100) Hagberg (2014): global: mean 76 (SD 17.4) Matthews (2019): significant improvements in all of the main scores, and in 2 out of the 3 subscores for prosthetic mobility, between the preoperative period and 2- and 5-years post implantation Al Muderis (2016): global: mean 83.52 (SD 18.4) Van de Meent (2013): global: 75 (42 to 100) 6MWT (5 studies): average value 388 metres Muderis (2016): Significant improvements (p=0.001) Muderis (2017): significant improvements, with a mean increase of 128% Atallah (2017): 311 (144 to 433) m McMenemy (2020): 402 m Al Muderis (2016): 419 ± 31.44 m Van de Meent (2013): 423 ± 21 TUG (6 studies): average 11.5 seconds Muderis (2016): Significant improvements (p=0.01) Muderis (2017): Mean reduction of 30% Atallah (2017): 18.65 (6.28 to 26,8) McMenemy (2020): 10.6 seconds (7.4 to 12.1) Al Muderis (2016): 8.74 ± 2.81 second Van de Meent (2013): 8.1 ± 0.7 second Upper limb: no clinical data were reported. | Complications rates (13 studies) Overall rate of complications: 75% (164 out of 216) Stoma Hypergranulation: 35% Implant related complications (including breakage): 27% Periprosthetic fractures/fracture above the implant: 18% Soft tissues redundancy: 8% Aseptic loosening of the implant: 8% Persistent pain: 4% Infection rates (16 studies) Overall rate of infections: 32% (201 out of 626) Superficial infections (163 out of 201) Deep skin/bone infections (38 out of 201) |
Leijendekkers RA 2017 | QOL Q-FTA problem score (in 2 cohort studies: Hagberg 2008, Brånemark 2014) at 1 year follow up and QFTA global score (in 3 cohort studies: van de Meent 2013, Brånemark 2014, Hagberg 2008) at 2 years follow up improved significantly with use of BAP compared with socket prosthesis General QOL (assessed using SF-36 in 2 cohort studies, Hagberg 2008, Brånemark 2014) The scores of physical health (physical functioning score, role-physical functioning score and PCS) improved significantly at 1 year and 2 years follow up with use of a BAP compared with socket prostheses use. SF-36 physical bodily pain subscale score improved significantly using BAP compared with socket prosthesis in one study at 1- and 2-years follow up (Hagberg 2008) but reported no change in another study at 1 year follow up (Brånemark 2014). Scores on other SF-36 subscales (physical general health, all mental health subscales) did not change significantly after BAP at 1- and 2-years follow up. One study [Hagberg 2014] using SF-6D reported an improvement in general health status at 2 years follow up using BAP compared with socket-prosthesis use Functional level Q-TFA Prothesis use score (3 cohort studies) All the 3 studies found that prosthesis use improved significantly with BAP compared with socket prosthesis at 1 year [van de Meent 2013, Brånemark 2014] and 2 years follow up [Hagberg 2008]. ROM and gait One cross-sectional study [Hagberg 2005] reported that range of hip motion was lower with socket prosthesis compared with BAP use at 2- and 10-years follow up. Another cross-sectional study [Frossad 2010] assessing temporal gait variables (cadence, duration gait cycle and duration support phase) reported that BAP use had a gait more similar to healthy subjects than socket prosthetic use at 1 year follow up. Another cohort study [Tranberg 2011] assessing gait kinematics in the sagittal plane found that during the stance phase use of a BAP increased hip extension and decreased anterior pelvic tilt compared with a socket-prosthesis use and are more similar to that of healthy subjects compared with socket-prosthesis use Activity level Q-TFA mobility score (3 cohort studies) All studies found that using a BAP use resulted in significant improvements in overall mobility score, capability sub-score and walking habit sub-score compared with socket prostheses use at 1 [Brånemark 2014] and 2 [Brånemark 2014, Hagberg 2008] years follow up, but there was no change in walking aid sub-score at 2 years follow up. Discomfort when sitting (1 cross-sectional study Hagberg 2005) Evidence shows that using a BAP was associated with less discomfort when sitting than use of a socket prosthesis. Discomfort when sitting was reported in 44% (n = 19) in the socket group and was common in people with less than 90 degrees of hip flexion motion (p= 0.025). In the BAP group, no subject had less than 90 degrees of flexion and 5% (n= 1) reported discomfort when sitting. Walking ability (cohort study van de Meent 2013) Walking ability improved significantly 1 year after BAP use compared with use of a socket prosthesis, both in terms of distance covered in 6-min and time needed to get up from a chair, walk 3-m up and down a walkway and sit again Energy cost of walking (2 cohort studies- van de Meent 2013, Hagberg 2014) Both studies found that use of a BAP reduced the energetic cost of walking significantly compared with use of a socket prosthesis at 1- and 2-years follow up. Participation level (1 study Hagberg 2008) Before BAP: 11 of the 18 participants worked, 2 years after BAP use 10 of the 18 participants worked (reason decrease; loosening of the implant). No difference reported | |
Hagberg 2020 | Q-TFA at 7-year follow up Q-TFA prosthetic use score (0 to 100): n = 54, mean (SD; range) 85 (25.0; 3 to 100), p=0.24 Q-TFA prosthetic mobility score (0 to 100): n = 54, mean (SD; range) 67 (17.8; 22 to 95), p=0.007 Q-TFA problem score (100 to 0): n = 54, mean (SD; range) 17 (10.8; 0 to 44), p=0.34 Q-TFA global score (0 to 100): n = 54, mean (SD; range) 74 (20.6; 17 to 100), p=0.047 Prosthetic activity grade compared with baseline n (%) At 2 years (n=85): 50 (59) higher score; 32 (38) equal score; 3 (4) lower score; p< 0.001 At 5 years (n=62): 42 (68) higher score; 19 (31) equal score; 1 (2) lower score; p<0.001 At 7 years (n=54): 36 (67) higher score; 17 (31) equal score; 1 (2) lower score; p<0.001 At 10 years (n=32): 22 (69) higher score; 6 (19) equal score; 4 (13) lower score; p<0.001 At 15 years (n=11): 5 (45) higher score; 6 (55) equal score; p=not reported Change in answer to the single Q-TFA question on the patient's overall situation as an amputee compared with baseline, n (%): At 2 years (n=81): 62 (77) better score; 14 (17) equal score; 5 (6) worse score; p<0.001 At 5 years (n=60): 47 (78) better score; 10 (17) equal score; 3 (5) worse score; p<0.001 At 7 years (n=52): 40 (77) better score; 11 (21) equal score; 1 (2) worse score; p<0.001 At 10 years (n=29): 21 (72) better score; 6 (21) equal score; 2 (7%) worse score; p<0.001 At 15 years (n=11): 7 (64) better score; 3 (27) equal score; 1 (9) worse score; p= not reported. | Mechanical complications leading to change in abutment or abutment screw % (n) 0 complications: 45% (50 out of 111) 1 complication: 13.5% (15 out of 111) 2 to 5 complications: 22.5% (25 out of 111) 6 to 10 complications: 9% (10 out of 111) More than 10 complications: 10% (11 out of 111) mean (SD; range) 3.3 (5.76; 0 to 26) Fixture survival (leading to change in abutment and/or abutment screw) At 2 years (n=90): 81% (95% CI 71% to 88%) At 7 years (n=55): 32% (95% CI 22% to 43%) At 15 years (n=14): 14% (95% CI 6% to 26%) Implant replacement and/or refitting (n=111, follow up 15 years) Implant revisions % (n): 16% (18 out of 111) 6% (7 out of 111) due to infection, 5% (6 out of 111) due to aseptic loosening and 5% (5 out of 111) due to fractures Revision-free survival of the fixture: At 2 years (n=90): 92% (95% CI 85 % to 96%) At 7 years (n=55): 89% (95% CI 80 % to 94%) At 15 years (n=14): 72% (95% CI 57 % to 83%) |
Thouvenin 2023 | Q-TFA at last follow up (mean 9.4, median 8, range 6 to 15) years (n=20 BAP) Prosthetic use score Mean (SD): from 54.8 (26.0) to 91.8 (22.7) Mean difference: +36.5, p<0.001 Prosthetic mobility score Mean (SD): from 66.8 (19.1) to 82.9 (20.7) Mean difference: +16.1, p<0.001 Problem score Mean (SD): from 30.4 (8.2) to 10.2 (5.4) Mean difference: −20.3, p<0.001 Global score Mean (SD): 41.7 (17.1) to 71.8 (18.6) Mean difference: +29.9, p<0.001 After 2 years, 75% (n=13) of the people participated in a professional activity; 50% (n=8) participated in a sports activity 12 people referred to their prosthesis using the term 'it's a part of me' | Mechanical complications % (n=17) Total: 59% (10 out of 17), number of events=44 Abutment: 59% (10 out of 17), number of events=43 Intramedullary screw: 6% (1 out of 17), number of events= 1 Bone fractures: 12% (2 out of 17), number of events=2 Infections Total: 7 6% (13 out of 17), number of events=37 Stage 1 (incisional discharge/fistula): 65% (11 out of 17), number of events=25 (68%) Stage 2: 18% (3 out of 17), number of events=4 Stage 3: 23% (4 out of 17), number of events=6 Stage 4: 12% (2 out of 17), number of events=2 Most treated on an outpatient basis, 8 required hospitalisation Stage 1 had antibiotic therapy; stage 2 to 3 had surgical debridement, abutment change and systemic antibiotic therapy) and stage 4 had implant removal, surgical debridement and antibiotic therapy Stump revision (for excessive soft tissue): 35% (6 out of 17), number of events=10 Neuroma surgery: 29% (5 out of 17), number of events=6 Implant survival rate Removal rate: 30% (6 out of 20) 2 were removed at 2 and 3 years due to aseptic loosening or non-osseointegration, which caused pain while walking. 4 were removed because of infection (1 for complications in the stump after 1 year, 3 at 9, 10, and 11 years for chronic infection and permanent pain) The Kaplan–Meier survival curve showed implant survival rates of 90% at 2 years, 70% at 10 years, and 60% at 15 years. |
Hollewarth 2020 | No efficacy outcomes were reported | Periprosthetic fractures Overall rate 4.2% (22 out of 518) Femoral OIP 6.3% (22 out of 347) Location of the fracture: Neck of femur 2 Intertrochanteric 14 Subtrochanteric 6 Location relative to implant within 2 cm of the proximal tip of the implant 86.4% (19 out of 22) more than 2 cm proximal of the tip 9% (2 out of 22) more than 2 cm distal of tip 5% (1 out of 22) Mechanism of injury Ground level fall 86% (19 out of 22) Twist 9% (2 out of 22) Kicking 5% (1 out of 22) Implant used for fixation. Dynamic hip screws 45% (10 out of 22) Reconstruction plates 41% (9 out of 22) Blade plate 5% (1 out of 22) Cannulated screws 5% (1 out of 22) Extension nail 5% (1 out of 22) No osseointegration implants required removal Prosthesis use for more than 16 hours daily before osseointegration 14% (3 out of 22) post fracture mobility 82% (18 out of 22) People with K-level more than 2 Before osseointegration 23% (5 out of 17) Post fracture 100% (22) Regression analysis identified a 3.89-fold increased risk of fracture for females (p = 0.007) and a 1.02-fold increased risk of fracture per kg above a mean of 80.4 kg (p = 0.046) |
Örgel 2022 | No efficacy outcomes were reported | Periprosthetic fractures: 10.7% (15 out of 140) Cause of fracture Slipped 13% (2 out of 15) Stumbling 33% (5 out of 15) Malfunction of the prosthesis 6.7% (1 out of 15) Intraoperative fracture (needed no surgical intervention) 46.7% (7 out of 15) Location of fracture Femur neck 2 Intertrochanteric 4 Subtrochanteric 2 Longitudinal split of the femur 5 Distal femur 2 Time to fracture mean 21.8 months Treatment of fracture Non-operative 53% (8 out of 15) Dynamic hip screw 46.7% (7 out of 15) 14 healed with no complications after 3 months. One postoperative fracture developed a clinically asymptomatic firm non-union. No devices were removed Outcomes in periprosthetic facture group compared with control group (with no fractures, n=19) after OIP treatment There was no significant difference for PMQ and K-level between the fracture and control group at follow-up times. However, a significant increase of the PMQ (p<0.001) and K-level (p<0.001) was observed after OIP treatment compared with baseline in both groups. The subgroup analysis showed a significant increase of the PMQ and K-level for both normal weight less than 25 kg/m2 (p=0.002) and overweight more than 25 kg/m2 people (p<0.001). |
Welke 2023 | QOL and mobility assessment (6.6 years in BAP group) SF-36 PCS, mean (SD) BAP group: 46.3 (8.1) Socket group: 46.9 (7.0) p=0.892 MCS, mean (SD) BAP group: 50.2 (7.3) Socket group: 53.7 (3.4) p=0.293 Q-TFA Global score, mean (SD) BAP group: 69.6 (19.0) Socket group: 74.0 (12.5) p=0.354 Problem score, mean (SD) BAP group: 10.3 (7.9) Socket group: 17.3 (11.2) p=0.063 Prosthetic mobility score, mean (SD) BAP group: 89.2 (12.7) Socket: 84.8 (12.8) p=0.493 Prosthetic use scores, mean (SD) BAP group: 85.0 (20.2) Socket group: 82.1 (13.1) p=0.745 Functional outcomes 6MWT, mean (SD) BAP group: 321.7 (74.0) metres Socket group: 315.5 (70.9) metres p=0.876 TUG performance, mean (SD) BAP group: 11.0 (3.3) seconds Socket group: 11.2 (2.6) seconds p=0.626 Gait analysis. ROM Hip flexion/extension, mean (SD) BAP group: 48.2 (6.2), socket group: 44.3 (7.4); p=0.064 Abduction BAP group: 23.2 (8.2), socket group: 18.0 (5.5); p=0.03 Knee flexion/extension, mean (SD) BAP group: 60.1 (9.9), socket group: 55.6 (11.6), p=0.347 Abduction BAP group: 12.7 (5.4), socket group: 6.7 (3.0), p=0.000 Ankle flexion/extension, mean (SD) BAP group: 17.5 (4.1), socket group: 15.5 (4.0), p=0.144 Abduction BAP group: 8.2 (4.2), socket group: 4.6 (2.1), p=0.003 Walking speed, mean (SD) BAP group: 1.15 ± 0.23 m/second Socket group: 1.13 ± 0.25 m/second (p = 0.843). Step width, mean (SD) BAP group: 0.19 (0.04) metres, Socket group: 0.24 (0.04) metres, (p = 0.001). | No safety data |
Procedure technique
Three different implant systems were used in most of the studies. Evidence was mainly on the latest version of the following systems:
OPRA implant system (press-fit and screw design, made of titanium in Sweden)
Endo-Exo-Femur-Prosthesis (press-fit design made of cobalt chromium molybdenum alloy, sealed with a titanium-niobium layer in Germany), and
OGAP-OPL (press-fit design and made of titanium in Australia).
These implant systems have undergone several design and material changes.
Two stages of surgery were common and the time between the first and the second surgery ranged from 4 to 8 weeks for the press-fit implants (OGAP-OPL and EEFP) and 6 months for the OPRA system (abutment that is press-fit and an abutment screw). Healing period, and time to load the prosthesis varied among the implant systems.
Efficacy
Functional outcomes
6MWT
In a HTA of 9 observational studies, 2 studies reported a statistically significant improvement in 6MWT scores. One of the prospective case series (van de Meent 2013 with ILP implant), reported a statistically significant change in mean score from 321 m before the procedure to 423 m at 1-year follow up (p=0.002). In another prospective case series (Al Muderis 2016d, with ILP and OGAP-OPL implants), the mean scores also improved in people who used a socket prosthesis from 281 m at baseline to 419 m at mean 1.8 years follow up (p<0.001). Wheelchair users reported a mean score of 411 m (but the preoperative score and p-value were not reported; Ontario Health 2019).
A systematic review of 17 observational studies on OIP implants for lower- and upper-limb amputation reported that the average value of 6MWT was 388 m (Balzani 2020).
In a cross-sectional observational study of 20 people with TFA and BAP comparing 17 people with TFA and socket prosthesis, the mean walking distance did not significantly differ between the groups after 6 minutes (BAP group 321.7 m, socket group 315.5 m, p=0.876; Welke 2023).
TUG test
In the HTA of 9 observational studies, 2 studies reported a statistically significant improvement in TUG scores. In one of the prospective case series (van de Meent 2013 with ILP implant), the mean score improved from 15.2 seconds before the procedure to 8.1 seconds at 1 year follow up (p=0.002). In another prospective case series (Al Muderis 2016d, with ILP and OGAP-OPL implants), the mean scores also improved for socket-prosthesis users from 14.59 seconds before the procedure to 8.74 seconds at mean 18 years follow up after the procedure (p<0.01). Wheelchair users had a follow-up score of 9.0 seconds, but the preoperative score and p-value were not reported (Ontario Health 2019).
The systematic review of 17 studies reported that the average value of TUG score was 11.5 seconds (Balzani 2020).
In the cross-sectional observational study of 20 people with TFA and BAP comparing 17 people with TFA and socket prosthesis, there was no statistically significant difference in TUG score between the 2 groups (BAP group 11 seconds, socket group 11.2 seconds, p=0.626; Welke 2023).
In a systematic review of 7 studies in people with a lower-extremity amputation using bone-anchored prostheses compared with socket prostheses, 1 cohort study (van de Meent 2013 with ILP implants and rehabilitation) reported that walking ability improved significantly 1 year after BAP use compared with use of a socket prosthesis, both in terms of distance covered in 6 minutes and time needed to get up from a chair, walk 3 m up and down a walkway and sit again. Two cohort studies (van de Meent 2013, Hagberg 2014 with OPRA implant and rehabilitation) found that use of a BAP reduced the energetic cost of walking significantly compared with use of a socket prosthesis at 1 and 2 years follow up. In the systematic review, 1 study (Hagberg 2008, with OPRA implants and rehabilitation) reported no difference in participation (activity) level (before BAP 11 of the 18 people worked, and at 2 years after BAP use 10 of the 18 people worked; Leijendekkers 2017).
In the same systematic review, 1 cross-sectional study (Hagberg 2005 with OPRA implants and rehabilitation) reported that using a BAP was associated with less discomfort when sitting than use of a socket prosthesis. Discomfort when sitting was reported in 44% (n=19) in the socket group and was common in people with less than 90 degrees of hip flexion motion (p=0.025). In the BAP group, no subject had less than 90 degrees of flexion and 5% (n= 1) reported discomfort when sitting (Leijendekkers 2017).
AMP
In the HTA, no studies reported on AMP. But, 1 prospective case series included in the HTA (Al Muderis 2016d) reported on K-levels based on previously reported AMP scores. K-level improved in 60% of people and was unchanged in 40% (p=0.001; Ontario Health 2019).
ROM
In the HTA, none of the studies reported on changes in ROM.
In the systematic review of 7 studies in people with a lower-extremity amputation using bone-anchored prostheses compared with socket prostheses, 1 cross-sectional study (Hagberg 2005, with OPRA implants and rehabilitation) reported that range of hip motion was lower with socket prosthesis compared with BAP use at 2 and 10 years follow up. Another cross-sectional study (Frossad 2010, with OPRA implants and rehabilitation) assessing temporal gait variables (cadence, duration gait cycle and duration support phase) reported that BAP users had a gait more similar to healthy people than socket prosthetic users at 1-year follow up. Another cohort study (Tranberg 2011, with OPRA implants and rehabilitation) assessing gait kinematics in the sagittal plane found that during the stance phase, users of a BAP increased hip extension and decreased anterior pelvic tilt compared with a socket-prosthesis users and are more similar to that of healthy people (Leijendekkers RA 2017).
In the cross-sectional observational study of 20 people with TFA and BAP comparing 17 people with TFA and socket prosthesis, statistically significant differences were observed in the abduction ROM for the hip, knee and ankle between the 2 groups (hip: BAP group 23.2, socket group: 18.0, p=0.03; knee BAP group: 12.7, socket group: 6.7, p=0.000; ankle: BAP group: 17.5, socket group: 15.5, p=0.144; Welke 2023).
HRQOL
Q-TFA
In the HTA of 9 studies, 3 studies reported a statistically significant improvement in Q-TFA scores. In 1 of the prospective case series (Brånemark 2014, with OPRA implant system) the mean score for prosthetic use increased from 47 (of possible 100) before surgery to 79 at 2-year follow up (p<0.001). Other domains (mobility, problems, and global health) also improved significantly (p<0.001). Another prospective case series (van de Meent 2013 with ILP implant) reported that prosthetic use improved significantly from 56 hours to 101 hours per week (p<0.001), and the global scores also significantly improved (p=0.001, other domains were not reported). The third study (Al Muderis 2016d) only reported scores for global health, which showed a statistically significant improvement (p<0.001; Ontario Health 2019).
In the systematic review of 17 studies, the postoperative mean score of Q-TFA was 73.8 (Balzani 2020).
In the systematic review of 7 studies in people with a lower-extremity amputation Q-TFA prothesis use score (in 3 cohort studies) improved significantly with BAP compared with socket prosthesis at 1 year (van de Meent 2013 with ILP implant and rehabilitation, Brånemark 2014 with OPRA implant and rehabilitation) and 2 years follow up (Hagberg 2008 with OPRA implant). The problem score (in 2 cohort studies: Hagberg 2008, Brånemark 2014) at 1 year follow up and global score (in 3 cohort studies: van de Meent 2013, Brånemark 2014, Hagberg 2008) at 2 years follow up improved significantly with use of BAP compared with socket prosthesis. Three cohort studies found that using a BAP resulted in significant improvements in overall mobility score, capability sub-score and walking habit sub-score compared with socket prostheses use at 1 year (Brånemark 2014) and 2 years (Brånemark 2014, Hagberg 2008) follow up, but there was no change in walking aid sub-score at 2 years follow up (Leijendekkers RA 2017).
In a prospective cohort study of 111 people with unilateral TFA who had BAP (with OPRA implant system), the Q-TFA scores demonstrated significantly more prosthetic use, better mobility, fewer problems, and an improved global health at 2, 5, 7, and 10 years compared with baseline (p<0.001 for all). At 15 years follow up, the problem score (p=0.020) and global score (p=0.004) significantly improved from baseline. At 7 years follow up (n=55), a higher activity grade (p=0.002) and higher prosthetic mobility score (p=0.007) and global scores (p=0.047) were reported in the group with 'any mechanical complication' (n=37) compared with those with 'no mechanical complication' (n=18; Hagberg 2020).
In a retrospective cohort study of 17 people (with 20 BAPs) at a mean follow up of 9.4 years, all Q-TFA scores improved statistically significantly. The mean prosthetic use score increased from 54.8 to 91.8 (p<0.001), prosthetic mobility score from 66.8 to 82.9 (p<0.001) and global score from 41.7 to 71.8 (p<0.001). The mean problem score decreased from 30.4 to 10.2 (p<0.001). After 2 years, 75% (n=13) of the people participated in a professional activity and 50% (n=8) participated in a sports activity (Thouvenin 2023).
In the cross-sectional observational study of 20 people with TFA and BAP comparing 17 people with TFA and socket prosthesis, the Q-TFA global score did not significantly differ between groups (BAP group 69.6, socket group 74.0, p=0.354). No statistically significant differences were found between the groups for the subscores. There were no significant differences reported for prosthetic mobility score (BAP group 89.2, socket group 84.8, p=0.493) and prosthetic use scores (BAP group 85, socket group 82.1, p=0.745) in both groups, respectively (Welke 2023).
SF-36
In the HTA of 9 studies, 2 studies reported data on the SF-36 health survey, a generic measure of QOL. One prospective case series (Brånemark 2014, with OPRA implant system) reported on all subscales of the SF-36. The improvement in QOL after DSF with an OIP implant was significant for the domains of physical functioning and role-physical and PCS (p<0.001) but there was no statistically significant improvement for other subscales (bodily pain, general health, vitality, social functioning, role-emotional, mental health). The mean scores for the MCS declined by 3 points, but this result was not statistically significant. Another prospective case series (Al Muderis 2016d, with ILP and OGAP-OPL implant) reported only on the PCS score, which showed a statistically significant improvement (baseline 37.09 to 47.29 at follow up, p<0.001) but did not report scores for any of the other subscales of the survey (Ontario Health 2019).
In the systematic review of 17 studies, the most common clinical scores used were MCS and PCS of SF-36 and the postoperative mean values of MCS and PCS related to lower limb were 55.1 and 45.4 respectively (Balzani 2020).
In the systematic review of 7 studies in people with a lower-extremity amputation using BAP compared with socket prostheses, the scores of physical health (physical functioning score, role-physical functioning score and PCS; assessed using SF-36 in 2 cohort studies, Hagberg 2008, Brånemark 2014 both with OPRA implants) improved significantly at 1 year and 2 years follow up with use of a BAP compared with socket prostheses use. SF-36 physical bodily pain subscale score improved significantly using BAP compared with socket prosthesis in 1 study at 1- and 2-years follow up (Hagberg 2008) but reported no change in another study at 1 year follow up (Brånemark 2014). Scores on other SF-36 subscales (physical general health, all mental health subscales) did not change significantly after BAP at 1- and 2-years follow up. One study (Hagberg 2014 with OPRA implant) using SF-6D reported an improvement in general health status at 2 years follow up using BAP compared with socket-prosthesis use (Leijendekkers RA 2017).
In the cross-sectional observational study of 20 people with TFA and BAP comparing 17 people with TFA and socket prosthesis, the PCS and MCS scores did not significantly differ between the groups (PCS: BAP group 46.3, socket group 46.9, p=0.892; MCS: BAP group 50.2, socket group 53.7, p=0.293; Welke 2023).
Safety
Superficial infection
In the HTA of 9 studies, 5 studies reported superficial infections. In 3 prospective case series the rates of 1 or more superficial infections ranged from 28% to 55% at mean 1.2 to 2.8 years follow up (Brånemark 2014, with OPRA implant system, Al Muderis 2016c with ILP, Al Muderis 2016d with both ILP and OGAP-OPL implants). In another retrospective case series (Al Muderis 2017e with OGAP-OPL), 45% (10 out of 22) people developed superficial infection at a mean follow up of 1.2 years, 3 of which were severe. Refashioning surgery (surgery performed on soft tissue) to control the infection was performed in 2 studies. The retrospective case series by Juhnke (2015) with ILP reported no superficial infections (Ontario Health 2019).
In a systematic review of 12 studies, the occurrence of infection was reported in 73% (11 out of 15) of cohorts assessed. The overall infection rate ranged from 23% to 49% in people who had screw implants compared with 0% to 77% in those who had press-fit implants and 0% in those who had the Compress implant (in 1 study). Soft-tissue infections in the skin-penetrating area (grade 1 to 2) occurred in 28% people who had screw implants and 0% to 57% of people who had press-fit implants, respectively. Bone infection (grade 3) occurred in 5% to 13% of those who had screw implants and 0% with press-fit implants, respectively. Infections resulting in implant loosening (grade 4) occurred in 8% to 11% of those who had screw implants and 3% to 29% of those who had press-fit implants, respectively. Analysis of infections rates according to the level of amputation showed that in people with TFA treated with press-fit implants, the overall infection rate ranged from 0% to 77% and in those with upper extremity amputation it was 44%. The rate of soft-tissue infections (grade 1 to 2) ranged from 0% to 57% in those with TFA treated with press-fit implants and 28% in those with upper extremity amputation. The rates of infection in people with TFA who had screw implants or those who had TTA was unknown (Atallah 2018).
In the systematic review of 17 observational studies, infections were evaluated in 16 studies. The overall rate of infections was 32% (201 out of 626 people); and of these 81% (163 out of 201) were superficial infections (Balzani 2020).
In the retrospective cohort study of 17 people (with 20 BAPs), the overall infection rate was 76% (13 out of 17), with 37 events. Of these, 68% (n=25) were stage 1 infections, 11% (n=4) were stage 2 infections, 16% (n=3) were stage 3 infections, and 12% (n=2) were stage 4 infections (involving septic loosening of the implant). Most infections (n=29) were treated on an outpatient basis without (n=22) or with (n=7) surgery; and 8 (22%) needed hospitalisation and postoperative care (Thouvenin 2023).
Deep or bone infection
In the HTA, one prospective case series (Brånemark 2014 with OPRA implants) reported that 8% (4 out of 51) of people had deep infection at 2 years follow up. The deep infection in one implant led to loosening of the implant, which was extracted 6 months after the second-stage surgery. Another retrospective case series with a mean 7.9-year follow up (Tillander 2017b, with OPRA implants) reported that osteomyelitis developed in 17% (16 out of 96) of people at a median time of 2.6 years from implantation. Of these, 13% (9 out of 69) of people had received an OIP during and after the OPRA rehabilitation protocol. All were treated with antibiotics and devices were extracted in 10 and reimplanted in 1 patient. Osteitis (treated with antibiotics) was reported in 6% (6 out of 96) of people. Authors also reported a 10-year cumulative risk of implant-associated osteomyelitis of 20% (95%CI 12 to 33). Another prospective case series (Tillander 2010a) with OPRA implants in 39 people with upper and lower-limb amputations, reported that 18% (6 out of 32) of people who had TFA developed a deep infection at mean 2.8 years follow up, all of whom needed surgical intervention. One prospective case series with ILP implants (Al Muderis 2016c) reported that 5% (4 out of 86) of people developed an abscess at a median follow up of 2.8 years. All were treated with antibiotics and surgical debridement. However, no deep infection was reported for ILP implants in another retrospective case series of 39 TFA with a mean follow up of 2.7 years (Juhnke 2015). In another prospective case series (Al Muderis 2016d) 6% (3 of 50) of people who had ILP or OGAP-OPL implants, developed deep infection at a mean follow up of 1.8 years. All were treated with antibiotics and surgical debridement (Ontario Health 2019).
In the systematic review of 12 studies, bone infection (grade 3) occurred in 13% of people with TFA treated with screw implants and 6% of those with upper extremity amputation. Rates in those with TFA treated with press-fit implants or in those with TTA are unknown. Implant loosening due to infection (grade 4) occurred in 0% to 11% of people with TFA (screw-fit: 11%, press-fit: 0% to 3%), 29% of people with TTA and 11% of those with upper extremity (trans-humeral) amputation (Atallah 2018).
In the systematic review of 17 observational studies, infections were evaluated in 16 studies. The overall rate of infections was 32% (201 out of 626 people); and of these 19% (38 out of 201) were deep infections localised at the bone or causing septic disease (Balzani 2020).
Bone fracture
In the HTA of 9 studies, one prospective case series (Brånemark 2014 with OPRA implant), reported that there were no periprosthetic fractures (around the implant) during the 2-year study period. Four people (8%) had fractures in locations other than the femoral bone. One retrospective case series (Jhunke 2025) reported 2 periprosthetic fractures at 2.5 to 3 years after implantation, and another prospective case series (Al Muderis 2016c) reported 3 femoral fractures at a mean follow up of 2.8 years. One prospective case series (Al Muderis 2016d with both ILP and OGAP-OPL) reported 4 (8%) periprosthetic fractures at a mean follow up of 1.8 years. The retrospective case series on OGAP-OPL alone (Al Muderis 2017e) did not report any fractures at 1 year follow up (Ontario Health 2019).
In the systematic review of 12 studies, the incidence of periprosthetic bone fracture was reported in 60% (9 out of 15) of cohorts. It ranged from 0% to 10% in those who had a press-fit implant (in 7 studies), 18% in those who had a Compress implant (in 1 study) and 0% in people who had a screw implant. In 3 studies, the cause of bone fracture reported was falls. No fractures occurred in people with upper extremity implants and those with TTA who had bone-anchored implants (Atallah 2018).
In the systematic review of 17 studies, postoperative complications were reported in 13 studies and the overall rate was 75% (164 out of 216 implants). Periprosthetic fractures or fractures above the implant were 18% and less frequent (Balzani 2020).
In a retrospective review of 518 OIP procedures in 458 people, periprosthetic fractures were reported in 4% (22 out of 518) of procedures. 86% (19 out of 22) of these occurred within 2 cm of the proximal tip of the implant and after a fall. There were no spontaneous fractures. These were most commonly fixed with dynamic hip screws (10) and reconstruction plates (9). None of the implants needed removal. The mobility (K-level) before osseointegration improved to and maintained to a K-level of 2 or higher after fixation of the fractures. All fractures united and 82% (18 out of 22) reported using the prosthesis more than 16 hours daily (Hollewarth 2020).
In another retrospective study of 140 people with OIP after TFA, periprosthetic fractures were reported in 11% (15 out of 140) of people. Five of these were intraoperative (not needed any surgical treatment) and 10 were post operative. All these were treated with implant retaining osteosynthesis and no devices were removed. Fourteen fractures healed without complications after a mean of 3 months and 1 postoperative fracture developed a clinically asymptomatic firm non-union. When outcomes in the periprosthetic fracture group (n=15) were compared with the control group (no fractures, n=19), there was no statistically significant difference for PMQ and K-level between the 2 groups at follow-up times. However, a significant increase of the PMQ (p<0.001) and K-level (p<0.001) was observed after OIP treatment compared with baseline in both groups. The subgroup analysis showed a significant increase of the PMQ and K-level for both normal weight less than 25 kg/m2 (p=0.002) and overweight more than 25 kg/m2 people (p<0.001; Örgel 2022).
Implant removal
In the HTA, 5 studies reported that implants were explanted due to deep infection, failed osseointegration, implant breakage, and fatigue failure (damage to the device due to repeated loading and unloading). Two of these studies with OPRA implant system (Brånemark 2014, Tillander 2010) reported implant removals due to deep infection in 1 each and failed osseointegration in 2 people during 2 years follow up. Two studies with ILP implants (Jhunke 2015, Al Muderis 2016c) reported failed integration in 2 people and implant breakage in 1 patient at mean 2.7 years or median 2.8 years follow up. Another prospective case series of 50 people both with ILP and OGAP-OPL implants (Al Muderis 2016d) reported failed integration in 1 patient and fatigue failure in another patient at mean 1.8 years follow up (Ontario Health 2019).
In the systematic review of 12 studies (15 cohorts assessed), the incidence of explantation (for infection, device breakage, bone fracture and implant loosening) ranged from 14% to 19% in people who had a screw implant, from 0% to 57% in those who had a press-fit implant and was 9% in those who had the Compress implant (in 1 study). The explantation rate in those with TFA was 17% to 18% with a screw implant, 0% to 13% with a press-fit implant and 9% with a Compress implant. Implant loosening and infection were other reasons for explantation of transfemoral implants and occurred in both the screw and press-fit implants but not the Compress implant. Also, the rate of explantation in those with THA was similar (17% to 19%) with screw implants. The rate of explantation was much higher in people with TTA ranging from 42% to 57% (Atallah 2018).
In the retrospective cohort study of 17 people (with 20 BAP) with a mean follow up of 9.4 years, 30% (6 out of 20) of implants required removal. Two were removed (at 2 and 3 years) for aseptic loosening or non-osseointegration, which caused pain while walking. Four implants were removed because of infectious complications (1 removed after a year for complications in the stump during load bearing, 3 removed at 9, 10, and 11 years for chronic infection and permanent pain). The Kaplan–Meier survival curve showed implant survival rates of 90% at 2 years, 70% at 10 years, and 60% at 15 years (Thouvenin 2023).
Reimplantation
In the systematic review of 12 studies (15 cohorts assessed), the incidence of reimplantation was reported in 87% (13 out of 15) of cohorts. It was successful in 100% of people who had the Compress implant (in 1 study), in 6% to 40% of people who had a screw implant (in 4 studies) and 25% to 100% of people who had press-fit implants (in 8 studies), respectively. Reimplantation was successful in 33% of people with THA (Atallah 2018).
The prospective case series of 111 people reported that 16% (18 out of 111) of people had implant revisions at 15 years follow up. Of these 6% (7 out of 111) were due to infection, 5% (6 out of 111) were due to aseptic loosening and 5% (5 out of 111) were due to fractures. Revision-free survival of the implant ranged from 92% at 2 years to 72% at 15 years follow up. Survival of the implant needing a change of the abutment, abutment screw or both ranged from 81% at 2 years to 14% at 15 years (Hagberg 2020).
Intramedullary and extramedullary breakage
In the HTA, 4 included studies reported breakage of intramedullary or extramedullary components of the osseointegrated prosthetic implant systems. In 1 prospective case series (Brånemark 2014 with OPRA implants), 8% (4 out of 51) of people needed exchange of abutment or abutment screws. In another prospective case series (Al Muderis 2016c with ILP implants), 2 people (2%) had implant breakage and 29% (25 out of 86) had breakage of the safety part that is added to the system to avoid the risk of fracture in case of excessive load. Three studies reported that no intramedullary breakage occurred during follow up (Brånemark 2014, Junke 2015 with ILP, Al Muderis 2017e with OGAP-OPL). (Ontario Health 2019).
In the systematic review of 12 studies (15 cohorts assessed), device breakage (due to fractures of the intramedullary implant, of the abutment [screw] and of the dual-cone adaptor [press-fit])was reported in 53% (8 out of 15) of the cohorts. Device breakage occurred in 27% to 45% of people with screw implant, 0% to 31% of those with press-fit implants, and 0% with Compress implant, respectively. No intramedullary device breakages were reported in people with TFA treated with screw implants, while it occurred in 1% of those with TFA treated with press-fit implants. No device breakages were reported in those with TTA with BAP. The incidence of intramedullary device breakage was 27% in those with transradial screw implants (Atallah 2018).
In the systematic review of 17 studies, the most common implant related complication rate, including breakage was 27% (Balzani 2020).
Non-infectious soft- tissue and bone complications
In the HTA, 2 studies reported on non-infectious soft-tissue and bone complications (Junke 2015 with ILP implant and Al Muderis 2016d with ILP and OGAP-OPL implants). These included hypergranulation at the stoma in 20% (17 out of 86) of people, which was treated with chemical cauterisation, hypertrophic bone formation in 10% (9 out of 86) of people, redundant soft tissue in 16% (14 out of 86) of people, which was excised, and rounding and resorption of distal femoral cortex in 20% (17 out of 86) of people (Al Muderis 2016d). Excessive granulation tissue at the stoma was reported in 1 person, which was removed (Jhunke 2015). It was not clear if other studies reported these adverse events (Ontario Health 2019).
In the systematic review of 12 studies (15 cohorts assessed), soft-tissue complications such as stoma hypergranulation was reported in 44% of TFAs with screw implants, in 3% to 20% TFAs with press-fit implants and 44% of those with THA treated with screw implants (in 1 study). Stoma-redundant tissue was reported in 3% to 16% TFAs with press-fit implants and 9% with Compress implants (Atallah 2018).
In the systematic review of 17 studies, complications assessed in 13 studies reported that the most common complication was stoma hypergranulation in 35% of people. Soft-tissue redundancy was reported in 8% of people (Balzani 2020).
The retrospective study of 17 people (20 BAPs) at a mean follow up of 9.4 years reported that 6 people had surgery for stump remodelling because of excessive soft tissue and 5 people underwent surgery for neuromas (Thouvenin 2023).
Implant loosening
In the systematic review of 12 studies (15 cohorts assessed), the incidence of implant loosening was reported in 60% (9 out of 15) cohorts. It ranged from 3% to 23% in people with screw implants (in 2 studies) and 0% to 29% in people with press-fit implants (in 4 studies), and 0% in those with the Compress implant (1 study), respectively. Implant loosening occurred in 0% to 3% in TFA with press-fit implants, 6% with screw implants; 29% of TTA with press-fit implants and in 13% and 23% of those with upper extremity implants (trans-humeral and thumb amputation treated with screw implants), respectively. Implant loosening was not reported in people with transradial amputation (Atallah 2018).
In the systematic review of 17 studies, complications were analysed in 13 studies and aseptic loosening of the implant was reported in 8% of people (Balzani 2020).
Mechanical complications
In the prospective cohort study of 111 people, 55% (61 out of 111) of people had at least 1 mechanical complication resulting in a change of the abutments (Hagberg 2020).
In the retrospective cohort study of 17 people (20 BAPs) at a mean follow up of 9.4 years, 65% (11 out of 17) people had mechanical complications. Forty-three abutments were changed in 10 people, intramedullary screw changed in 1 and bone fractures treated in 2 people by osteosynthesis (Thouvenin 2023).
Anecdotal and theoretical adverse events
Expert advice was sought from consultants who have been nominated or ratified by their professional society or royal college. They were asked if they knew of any other adverse events for this procedure that they had heard about (anecdotal), which were not reported in the literature. They were also asked if they thought there were other adverse events that might possibly occur, even if they had never happened (theoretical).
They listed the following anecdotal adverse events:
2 people 'died by suicide after their bone-anchored implants had failed because of deep infection, and reimplantation had been refused'
psychological issues
osseointegrated components 'dual-cone' breakage.
They listed the following theoretical adverse events:
likely increased risk of injury by being more active and could lead to falls and risk of bone fracture
bone infections and risk of need for higher amputation
ongoing management of stoma
other medical issues and infection in the body.
Eight professional expert questionnaires for this procedure were submitted. Find full details of what the professional experts said about the procedure in the specialist advice questionnaires for this procedure.
Validity and generalisability
Most of the evidence was on OIP implants for people with above-the-knee amputation. A small number of people with below the knee amputation or upper extremity amputation were included.
Systematic reviews and HTA included mainly observational studies with high risk of bias and some studies with the same patient populations.
Follow up ranged from 1 to 15 years. But, long-term results are based only on a small number of people.
Evidence was mainly on 3 implant systems (OPRA, ILP, OGAP-OPL). Several other OIP implant systems are currently under development. These include ITAP (UK), POP (US), Compress (US) and the keep walking advanced (US).
A 2-stage surgical procedure was commonly used, and this has been modified over time.
The majority of the studies are conducted outside the UK, and it is not clear if these results might be generalisable to current practice in the UK.
There are no RCTs comparing DSF with conventional or no prosthesis.
Studies reporting on osseoperception are added to other relevant studies section.
Existing assessments of this procedure
The NHS England Clinical commissioning policy: direct skeletal fixation for transfemoral limb loss (adults) was published in 2023. It recommends that direct skeletal fixation is not used as an option in routine commissioning for transfemoral limb loss within the criteria set out in this document. The policy is restricted for use in adults to avoid disruption of the growth plate in younger people.
The NHS England Evidence Review: Direct skeletal fixation for transfemoral limb loss in adults was published in October 2022. The evidence included in this review is insufficient to draw conclusions about the clinical effectiveness and safety of DSF compared with no prosthetic use in people with transfemoral limb loss who are unable to tolerate conventional socket use.
The key limitation to identifying evidence on the effectiveness of DSF compared with no prosthetic use in people who are unable to tolerate conventional socket use is the lack of studies comparing DSF with no prosthetic use in this group. Five case series (3 prospective and 2 retrospective) were identified ranging in size from 50 to 111 people and reporting results at multiple time points up to 15 years. This very low certainty, non-comparative evidence in people with transfemoral limb loss who are unable to tolerate conventional socket use suggests that DSF improves functional outcomes as measured by the TUG test and 6MWT at 2 years, QOL as measured by the SF-36 and Q-TFA up to 10 years, mobility as measured by prosthetic activity grades up to 10 years and wheelchair use up to 3 years follow up. Across the studies, at different time points up to 15 years, rates of implant replacement, refitting or both ranged from 3% to 34%, and extraction due to infection ranged from 6% to 10%. Over half of people experienced an adverse event as reported by 1 study at 2 years, and across the studies the percentage of people experiencing infections at different time points up to 8 years ranged from 17% to 42%.
No evidence was identified for particular sub-groups of people who would benefit more from DSF.
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