Interventional procedure overview of direct skeletal fixation of limb prostheses using an intraosseous transcutaneous implant
Closed for comments This consultation ended on at Request commenting lead permission
Other relevant studies
Other potentially relevant studies to the IP overview that were not included in the main evidence summary (tables 2 and 3) are listed in table 5. Studies with fewer than 5 patients were excluded.
Article | Number of patients and follow up | Direction of conclusions | Reason study was not included in main evidence summary |
|---|---|---|---|
Atallah R, van de Meent H, Verhamme L et al. (2020) Safety, prosthesis wearing time and health-related quality of life of lower extremity bone-anchored prostheses using a press-fit titanium osseointegration implant: A prospective one-year follow-up cohort study. PLoS One. 9;15(3): e0230027. | Cohort study N= 91 people with lower-limb amputation treated with bone-anchored prostheses using titanium press-fit osseointegration implants (53, 16 and 21 OFI-C, OFI-Y and OTI), OFI-C indicated for a long femoral remnant, OFI-Y indicated for a short femoral remnant, or OTI. 1 year follow up. | Titanium osseointegration implants can be safely used within a 1-year follow-up period. The performance improved compared with the use of a socket-suspended prosthesis. | More comprehensive studies added to evidence summary. |
Akhtar MA, Hoellwarth JS, Tetsworth K et al. (2022) Osseointegration following transfemoral amputation after infected total knee replacement: A case series of 10 patients with a mean follow-up of 5 years. Arthroplast Today. 21; 16:21-30. | Retrospective cohort study 10 people who had prior infected TKR had TFA and treated with TOFA press-fit implants systems. Follow up: 2 years | Transfemoral osseointegration confers significantly better mobility and QOL versus knee fusion or a TFA with traditional socket prostheses following infected TKR. | More comprehensive studies added to evidence summary. |
Akhtar MA, Hoellwarth JS, Al-Jawazneh S et al. (2021) Trans-tibial osseointegration for patients with peripheral vascular disease: A case series of 6 patients with minimum 3-year follow up. JB JS Open Access. 6(2): e20.00113. | Case series N=6 people with peripheral vascular disease and TTA had osseointegration with press-fit custom implant. Follow up: 3 years | All people survived through 2 years and reported improvement in mobility and QOL. 3 people had superficial soft-tissue infections. One patient died from cardiac causes. | More comprehensive studies added to evidence summary. |
Atallah R, van de Meent H, Verhamme L et al. (2020) Safety, prosthesis wearing time and health-related quality of life of lower extremity bone-anchored prostheses using a press-fit titanium osseointegration implant: A prospective one-year follow-up cohort study. PLoS One. 9;15(3): e0230027. | N=90 people with lower-limb amputation treated with bone-anchored prostheses using titanium press-fit osseointegration implants OFI-C (n=53) indicated for a long femoral remnant OFI-Y (n=16) indicated for a short femoral remnant, or OTI (n=21). Follow up: 1 year | Titanium osseointegration implants can be safely used within a 1-year follow-up period. The performance improved compared with the use of a socket-suspended prosthesis. | More comprehensive studies added to evidence summary. |
Atallah R, Li JJ, Lu W, Leijendekkers R et al. (2017) Osseointegrated Trans-tibial Implants in Patients with Peripheral Vascular Disease: A Multicenter Case Series of 5 Patients with 1-Year Follow up. J Bone Joint Surg Am. 99(18):1516-1523. | Case series N=5 people with peripheral vascular disease and TTA had osseointegration with press-fit custom implant. Follow up: 1 year. | The mobility of all people was improved (able to walk and perform daily activities). Four people were pain-free at 12 months. Two people had superficial soft-tissue infection. | More comprehensive studies added to evidence summary. |
Al Muderis M, Lu W, Li JJ. (2017) Osseointegrated Prosthetic Limb for the treatment of lower limb amputations: Experience and outcomes. Unfallchirurg. 120(4):306-311. | Retrospective study N=22 people who received the OPL implant. Follow up: 1 year | The results demonstrate that osseointegration surgery using the OPL is a relatively safe and effective procedure for the reconstruction and rehabilitation of lower-limb amputees. | Study included in systematic reviews added to evidence summary |
Al Muderis MM, Lu WY, Li JJ et al. (2018) Clinically Relevant Outcome Measures Following Limb Osseointegration; Systematic Review of the Literature. J Orthop Trauma; 32: e64–e75. | Systematic review 21 observational studies 788 lower-limb amputees, 709 OIs observed, and 79 prosthetic socket user controls. (Mainly transfemoral, only 2 studies on upper-limb amputations) Follow up: 1 to 2 years. | Randomised, long-term, trials are needed to prove efficacy of OI compared with socket prosthetic attachment. Osseointegration was equivalent to sockets in most studies. In some cases, it was superior. It is a promising alternative to socket prosthetic attachments for extremity amputees. | More comprehensive studies added to evidence summary. |
Al Muderis M, Khemka A, Lord SJ et al. (2016) Safety of osseointegrated implants for transfemoral amputees: a two-center prospective cohort study. J Bone Joint Surg Am. 98(11):900-9. | Prospective cohort study N=86 people (91 implants) Level of amputation: transfemoral. Device used: ILP (press-fit OIP) Median follow up 34 months. | Severe infections resulting in septic implant loosening are rare. Mild infection and irritation of the soft tissue in the skin-penetration area are common; these complications can be managed with simple measures. Protocols for adequate surgical management of the peri-implant soft tissue are essential. | Study included in systematic reviews added to evidence summary. |
Al Muderis MA, Lu W, Glatt V et al. (2018) Two-stage osseointegrated reconstruction of post-traumatic unilateral transfemoral amputees. Mil Med. 183 (1):496-502. | Prospective case series N= 37 post-traumatic unilateral transfemoral amputees. Device used: ILP (press-fit OIP) 2-year follow up. | Clinical outcomes were significantly improved. All people were able to ambulate after osseointegrated reconstruction. Sixteen people experienced infection but were managed without implant removal. One periprosthetic fracture occurred due to increased activity and was revised. | Study included in systematic reviews added to evidence summary. |
Brånemark R, Berlin O, Hagberg K et al. (2014) A novel osseointegrated percutaneous prosthetic system for the treatment of patients with transfemoral amputation: A prospective study of 51 patients. Bone Joint J. 96-B (1):106-13. | Prospective cohort study N=51 people with 55 TFAs had OPRA system. Follow up: 2 years | Cumulative survival was 92%. The Q-TFA showed improved prosthetic use, mobility, global situation and fewer problems (all p<0.001). The physical function SF-36 scores were also improved (p<0.001). Superficial infection 55%. The implant was removed in 4 people because of loosening. | Study included in systematic reviews added to evidence summary. |
Brånemark RP, Hagberg K, Kulbacka-Ortiz K et al. (2019) Osseointegrated percutaneous prosthetic system for the treatment of patients with transfemoral amputation: A prospective five-year follow-up of patient-reported outcomes and complications. J Am Acad Orthop Surg. 15;27(16): e743-e751 | Prospective cohort study N=51 people (55 legs) with TFA had OPRA system. Follow up: 5 years | Cumulative fixture survival rate was 92%, and the revision-free survival rate was 45%. 34 people had 70 superficial infections, 11 had 14 deep infections. 15 had mechanical complications. 4 fixtures were removed. S Significant improvements in use of the prosthesis, better mobility, fewer issues, and improved physical HRQOL (all p<0.0001) compared with baseline reported. | Study included in systematic reviews added to evidence summary |
Black GG, Vaeth AM, Chen Y et al. (2023) Osseointegration for lower limb amputation: understanding the risk factors and time courses of soft-tissue complications. Ann Plast Surg. 90 (6S Suppl 5): S452-S456. | Retrospective analysis N=60 people (35 transfemoral and 25 TTAs). Follow up: 22 months | Postoperatively, 25 people developed soft-tissue infections, 5 developed osteomyelitis, 6 had symptomatic neuromas, and 7 required soft-tissue revisions. Soft-tissue infections were positively correlated with obesity and female sex. | More comprehensive studies added to evidence summary. |
Davis-Wilson HC, Christiansen CL, Gaffney BMM et al. (2023) Improvements in disability and function in people with lower-limb amputation one year after prosthesis osseointegration. Prosthet Orthot Int. 47(4):343-349. | Cohort study N=12 people (9 transfemoral and 3 TTAs underwent osseointegration with press-fit implants) Follow up: 1 year. | Participants reported less disability and greater function in their prosthesis post-osseointegration. | More comprehensive studies added to evidence summary. |
Gaffney BMM, Davis-Wilson HC, Christiansen CL et al. (2023) Osseointegrated prostheses improve balance and balance confidence in individuals with unilateral transfemoral limb loss. Gait Posture.100:132-138. | Cohort study N=10 people with unilateral TFA had osseointegrated prosthesis. | Improvements in postural sway, reductions in gait variability, and greater balance confidence indicate that osseointegrated prostheses improve balance for people with unilateral TFA compared with socket prosthesis. | Biomechanical effect. More comprehensive studies added to evidence summary. |
Geiger, Erik J. MD; Hoellwarth, Jason S et al. (2022) Robert MD. Osseointegration of the tibia after a primary amputation. JBJS Essential Surgical Techniques 12(4): p e22.00005, | Review | With the safety of osseointegration demonstrated and the high prevalence of TTAs, it is important that osseointegration be utilised in the rehabilitation and reconstruction offered to people undergoing TTA. | Review |
Gerzina C, Potter E, Haleem AM et al. (2020) The future of the amputees with osseointegration: A systematic review of literature. Journal of Clinical Orthopaedics and Trauma 11, S142eS148 | Systematic review 9 observational studies (211 to 242 people) 234 to 267 implants, mainly transfemoral, (only 4 transradial, 4 transulnar, 3 trans-humeral, and 1 trans-tibial). Follow up more than 12 months. | Osseointegration is an effective alternative to socket prosthesis in transfemoral amputees. Trans-tibial and upper extremity implants are underreported and clear indication for their effectiveness over socket prosthesis does not exist. Minor complications such as soft-tissue infections are common. | More comprehensive studies added to evidence summary. |
Gholizadeh H, Abu Osman NA, Eshraghi A et al. (2014) Transfemoral prosthesis suspension systems: a systematic review of the literature. Am J Phys Med Rehabil. 93:809-823. | Systematic review N=16 studies (11 prospective and 5 surveys). Level of amputation: mainly transfemoral. Follow up varied. | No clinical evidence was found as a standard system of suspension and socket design for all transfemoral amputees. However, among various suspension systems for transfemoral amputees, the soft insert or double socket was favoured by most users in terms of function and comfort. | More comprehensive studies added to evidence summary. |
Hagberg K, Haggstrom E, Uden M et al. (2005) Socket versus bone-anchored trans-femoral prostheses: hip range of motion and sitting comfort. Prosthetics and Orthotics International 29(2): 153–63. | Non-randomised comparative study N=63 people with unilateral TFA Socket prosthesis = 68% (43 out of 63) Osseointegrated BAP OPRA= 32% (20 out of 63) Median follow up (for BAP): 5 years (range 3 to 10 years) | Transfemoral prosthetic socket significantly reduces the ROM of the hip and reported very few problems with discomfort when sitting. | Study included in systematic reviews added to evidence summary. |
Hagberg K, Brånemark R, Gunterberg B et al. (2008) Osseointegrated trans-femoral amputation prostheses: prospective results of general and condition-specific quality of life in 18 patients at 2-year follow up. Prosthetics and Orthotics International; 32(1): 29 – 41. | Prospective case series N=18 people with TFA had OPRA OIP implanted. Follow up: 2 years | 7 out of 18 people used the OI prosthesis; 1 did not due to pain and loosening of the implant. Four of the scales of the SF-36 and all 4 scores of Q-TFA were statistically significantly improved at follow up showing superior general physical HRQOL, increased prosthetic use, better prosthetic mobility, fewer problems and a better global amputation situation. | Study included in systematic reviews added to evidence summary. |
Hagberg K, Hansson E, Brånemark R. (2014) Outcome of percutaneous osseointegrated prostheses for patients with unilateral transfemoral amputation at two-year follow up. Arch Phys Med Rehabil. 95(11):2120–7. | Prospective case-control study N=39 people with unilateral TFAs had OPRA OIP implantation. Follow up: 2 years | Two years after intervention, people with a unilateral TFA treated with an OPRA implant showed important improvements in prosthetic function and physical QOL. However, walking aids used and the presence of phantom limb pain and pain in other extremities were unchanged. | Study included in systematic reviews added to evidence summary. |
Hagberg K and Brånemark R (2009) One hundred patients treated with osseointegrated transfemoral amputation prostheses—rehabilitation perspective. Journal of Rehabilitation Research & Development, 46 (3), 331-344 | N= 100 people with 106 OI implants (OPRA) Follow up: 3 months– 17.5 years. | 68 people are using their prostheses and 32 are not. The majority of treatment failures occurred in people before we established the OPRA protocol. The implementation of graded rehabilitation is considered to be of utmost importance for improved results. | Study included in systematic reviews added to evidence summary. |
Hagberg K (2018): Bone-anchored prostheses in patients with traumatic bilateral transfemoral amputations: rehabilitation description and outcome in 12 cases treated with the OPRA implant system, Disability and Rehabilitation: Assistive Technology. | Prospective cohort study N=12 people with bilateral TFAs had OPRA implanted. Median follow-up time was 7 years (range 1 to 20 years). | Bone-anchored prostheses in people with bilateral TFAs resulted in more prosthesis use during everyday locomotion, due hypothetically to improved comfort while wearing prostheses. | Larger studies with longer follow up included in evidence summary. |
Hagberg K, Ghasemi Jahani SA et al. (2022) Osseointegrated prostheses for the rehabilitation of patients with transfemoral amputations: A prospective ten-year cohort study of patient-reported outcomes and complications. J Orthop Translat. 20; 38:56-64. | Prospective cohort study N= 51 people with TFAs treated between 1999 and 2007 with the OPRA system. Follow up: 10 years | PROs showed statistically significant mean improvements between baseline and the ten-year follow up with regard to all Q-TFA scores. Eight had implants removed. The revision-free survival rates were 83%. Mechanical complications were 3.9 per 10 person-years. No significant difference in the incidence of deep infections from 5 to 10 years. | Larger studies with longer follow up included in evidence summary. |
Haggstrom E, Hagberg K, Rydevik B et al. (2013) Vibrotactile evaluation: Osseointegrated versus socket-suspended transfemoral prostheses. JRRD, 50 (10), 1423-1434. | 17 people with TFA tested preoperatively with socket-suspended prostheses and after 2 year with OI prostheses and a control group (n = 17) using socket-suspended prostheses. | Differences between the OI and the control groups were found in the highest frequencies in which the OI prosthesis showed reduction of the vibrometric signal. | More comprehensive studies added to evidence summary. |
Haidary A, Hoellwarth JS, Tetsworth K et al. (2023) Transcutaneous osseointegration for amputees with burn trauma. Burns. 49(5):1052-1061. | Retrospective review N=5 people (1 unilateral transfemoral amputee (TFA), 1 unilateral trans-tibial (TTA),1 bilateral TFA, and 2 bilateral TTA) had ILP/OPL. Follow up average 3.8 years | No issues of skin compatibility or pain associated with the implant. Three people underwent subsequent surgical debridement, one of whom had both implants removed and eventually reimplanted. | More comprehensive studies added to evidence summary. |
Hansen RL, Langdahl BL, Jørgensen PH et al. (2019) Changes in periprosthetic bone mineral density and bone turnover markers after osseointegrated implant surgery: A cohort study of 20 transfemoral amputees with 30-month follow up. Prosthet Orthot Int. 43(5):508-518. | Prospective cohort study N=19 people with TFAs treated with osseointegrated implants -OPRA system Follow up: 30 months. | Implant removal was associated with loss of periprosthetic bone mineral density and increase in C-telopeptide of type-I collagen in the years following osseointegrated surgery. | More comprehensive studies added to evidence summary. |
Hansen CH, Hansen RL, Jørgensen PH et al. (2019) The process of becoming a user of an osseointegrated prosthesis following transfemoral amputation: a qualitative study, Disability and Rehabilitation, 41:3, 276-283, | Descriptive analysis Data were collected through in-depth interviews with 7 participants who had undergone transfemoral implant with osseointegrated prosthesis (OPRA system). | Participants experienced increased action space and a more positive outlook on life. It took determination and stamina to become a user and participants faced several challenges. | More comprehensive studies added to evidence summary. |
Hebert JS, Rehani M, Stiegelmar R (2017) Osseointegration for lower-limb amputation: A systematic review of clinical outcomes. JBJS Rev. 5(10): e10 | Systematic review N=14 observational studies (6 prospective and 8 retrospective) N=482 people. Level of amputation: transfemoral in 12 studies (n=467), trans-tibial in 1 study (n=5), and upper and lower extremity in 1 study (transulnar: 4, transradial: 4, trans-humeral: 3). Device used: OPRA in 6 studies, ILP in 5 studies, OPL in 3 studies. Follow up varied in studies (3 months to 17.5 years). | Infection and soft-tissue irritation at the stoma were the most common complications. Changes in implant design, surgical technique, perioperative and postoperative care, and rehabilitation protocols have resulted in improvements in functional outcomes and HRQOL, and reduction in rates of complications. | More comprehensive studies added to evidence summary. |
Hoellwarth JS, Tetsworth K, Rozbruch SR et al. (2020) Osseointegration for amputees: current implants, techniques, and future directions. JBJS Rev.8(3): e0043. | Review of lower-extremity amputations and osseointegration. | There are different osseointegrated implant designs, surgical techniques, and rehabilitation protocols. The risks, infection and periprosthetic fracture are not frequent. | Review |
Hoellwarth JS, Reif TJ, Henry MW et al. (2022) Unexpected positive intraoperative cultures (UPIC) at index osseointegration do not lead to increased postoperative infectious events. J Bone Jt Infect. 7(4):155-162. | Retrospective chart review 8 people with UPIC and 22 people with negative intraoperative cultures (NIC) who had at least 1 year of post-osseointegration follow up. | UPIC at the time of primary osseointegration with subsequent antibiotic therapy does not appear to predispose to an increased risk of additional infection-related management compared with NIC through 1-year-follow up. | More comprehensive studies added to evidence summary. |
Hoellwarth JS, Tetsworth K, Oomatia A et al. (2022) Association between osseointegration of lower extremity amputation and mortality among adults. JAMA Netw Open.5(10): e2235074. | Retrospective cohort study N=485 people with amputation of a lower-extremity (transfemoral and trans-tibial) who underwent TOPS implantation. Follow up: 10 years | 4% (19) died at mean 2.2 years,17 were unrelated (cardiac issues) and 2 infectious complications. The findings suggest that people who had TOPS implanted rarely die of problems associated with the procedure but instead usually die of unrelated causes. | More comprehensive studies added to evidence summary. |
Hoellwarth JS, Oomatia A, Tetsworth K et al. (2023) Bone density changes after 5 or more years of unilateral lower extremity osseointegration: observational cohort study. Bone Rep. 18:101682. | Registry review of 5 transfemoral and 4 trans-tibial unilateral amputees who had DXA performed preoperatively and after 5 years. | Single-stage press-fit TOPS may facilitate significant BMD improvement to unilateral lower-extremity amputees with local disuse osteoporosis. | BMD changes assessed. More comprehensive studies added to evidence summary. |
Jacobs R, Brånemark R, Olmarker K et al. (2000) Evaluation of the psychophysical detection threshold level for vibrotactile and pressure stimulation of prosthetic limbs using bone anchorage or soft-tissue support. Prosthetics and Orthotics International 24: 133–42. | Non-randomised comparative study N=32 limbs Socket prosthesis = 47% (15 out of 32; 7 upper limbs, 8 lower limbs) Osseointegrated BAP = 53% (17 out of 32; 9 upper limbs, 8 lower limbs) Follow up not reported. | Detection thresholds for pressure and especially vibratory stimulation of prosthetic limbs were generally higher than for control limbs. The outcome was related to the prosthetic limb design with bone-anchored prostheses yielding better perception than socket prostheses. | Study included in systematic reviews added to evidence summary. |
Jönsson S, Caine-Winterberger K, Brånemark R. (2011) Osseointegration amputation prostheses on the upper limbs: methods, prosthetics and rehabilitation. Prosthet Orthot Int. 35(2):190-200. | Case series N=37 upper-limb cases were treated and fitted with prosthesis: 10 thumbs, 1 partial hand, 10 transradial and 16 THA | Patients indicated that function and QOL had improved since osseointegration. It is an important platform for present and future prosthetic technology. The prosthetic situation is improved due to the stable fixation, freedom of motion and functionality. | Surgical procedure description More comprehensive studies added to the summary of evidence. |
Juhnke DL, Beck JP, Jeyapalina S et al. (2015) Fifteen years of experience with Integral-Leg-Prosthesis: Cohort study of artificial limb attachment system. J Rehabil Res Dev. 2015;52(4):407-20 | Retrospective cohort study N=69 people with TFA were fitted with ILPs Group 1:people fitted with first designs and procedure iterations (n=30) Group 2: people fitted with the final design (n=39) Follow up: 15 years | High rate of stoma-associated infections seen in group 1. No infections in group 2. The reduction in the infection rate was attributed to the clinically based, empirically driven changes in design and surgical techniques. | Study included in systematic reviews added to evidence summary. |
Kunutsor S, Gillatt D, Blom A (2018). Systematic review of the safety and efficacy of osseointegration prosthesis after limb amputation. British Journal of Surgery, 105(13), 1731-1741. | Systematic review 13 observational studies (21 articles) included (transfemoral 14, upper arm 7) devices used: mainly OPRA, ILP/EEP, OGAP-OPL Follow up: 1 – 3 years. | Osseointegration of limb amputations confers increased prosthetic use, better sitting comfort, improved walking ability, mobility, gait, and QOL. However, it is associated with an increased risk of soft-tissue infections. Robust evidence from trials is warranted. | More comprehensive studies added to evidence summary. |
Leijendekkers RA, van Hinte G, Frölke JP et al. (2019) Functional performance and safety of bone-anchored prostheses in persons with a transfemoral or trans-tibial amputation: a prospective one-year follow-up cohort study. Clin Rehabil. 33(3):450-464. | Prospective cohort study N= 40 people who had transfemoral (31) or trans-tibial (9) osseointegration implant procedure followed by a predefined rehabilitation programme. Follow up: 1 year | Strength, prosthetic use, walking distance, HRQOL, and satisfaction level increased significantly at 6- and 12-month follow up compared with baseline (p ≤ 0.002). The TUG improved significantly at 12-month follow up compared with baseline (p = 0.005). Wheelchair-boundedness decreased from 12 out of 40 participants at baseline to 0 at follow ups. The 6MWT and back pain did not change over time. Stump pain was present in 22 out of 40 of people at 12-month follow up, respectively. An uneventful course was completed by 19 out of 31 transfemoral and 4 out of 9 trans-tibial bone-anchored prostheses users. | More comprehensive studies added to evidence summary. |
Lennerås M, Tsikandylakis G, Trobos M et al. (2017) The clinical, radiological, microbiological, and molecular profile of the skin-penetration site of transfemoral amputees treated with bone-anchored prostheses. J Biomed Mater Res A. 105(2):578-589. | Prospective cohort study N=30 TFA people scheduled for abutment exchange or removal. | Relationships exist between clinical, radiological, microbiological, and molecular assessments of the percutaneous area of TFAs. Further long-term studies are required and unravel the role of host-bacteria interactions in the skin, bone canal and on the abutment for the longevity of percutaneous implants as treatment of TFA. | More comprehensive studies added to evidence summary. |
Li Y, Brånemark R. (2017) Osseointegrated prostheses for rehabilitation following amputation: The pioneering Swedish model. Unfallchirurg. 120(4):285-292. | Reviews on extremity osseointegration surgeries in Sweden and the development of the OPRA program. | The development of the OPRA program allows for structured rehabilitation with standard surgical techniques to achieve adequate bone–fixture integration. | Review |
Li Y, Lindeque B. (2018) Percutaneous Osseointegrated Prostheses for Transfemoral Amputations. Orthopedics. 1;41(2):75-80. | Review on patient-centred evaluation, surgical technique, and postoperative rehabilitation protocol. | The outcomes with OPRA and ILP devices have confirmed the tremendous advantages of bone-anchored prostheses over socket prostheses. | Review |
Lundberg M, Hagberg K, Bullington J. (2011) My prosthesis as a part of me: a qualitative analysis of living with an osseointegrated prosthetic limb. Prosthet Orthot Int. 35(2):207-14. | Qualitative phenomenological research method N=13 people with unilateral upper or lower-limb amputation (10 transfemoral, 2 trans-humeral, 1 transradial), who had been using OI prostheses for 3 to 15 years. | The most important finding was that the change went beyond the functional improvements, integrating the existential implications in the concept of QOL. | More comprehensive studies added to evidence summary. |
Matthews DJ, Arastu M, Uden M et al. (2019) UK trial of the Osseointegrated Prosthesis for the Rehabilitation for Amputees: 1995-2018. Prosthet Orthot Int. 43(1):112-122. | Prospective cohort study N=18 transfemoral amputees received unilateral implants (OPRA system) 12.3 years follow up | This small cohort of people demonstrates osseointegrated prosthesis allows prolonged usage and improves people's QOL compared with conventional prostheses. | Study included in systematic review added to evidence summary. |
McMenemy L, Ramasamy A, Sherman K et al. (2020) Direct Skeletal Fixation in bilateral above-knee amputees following blast: 2 year follow up results from the initial cohort of UK service personnel. Injury. 51, 735-743. | Retrospective analysis of a prospective database 7 people (14 femoral amputations) who had undergone implantation with the Australian OGAP-OPL prosthesis. Follow up mean 46 months | At 2 years follow up, the absence of significant infective complications suggests DSF may be utilised in the blast injured despite chronic polymicrobial colonisation. Longer term surveillance of these people is required to assess the long-term suitability of this technique in this cohort of people. | Study included in systematic review added to evidence summary. |
Mohamed J, Reetz D, van de Meent H et al. (2022). What Are the Risk Factors for Mechanical Failure and Loosening of a Transfemoral Osseointegrated Implant System in Patients with a Lower-limb Amputation? Clin Orthop Relat Res.1;480(4):722-731. | Retrospective cohort study. N=58 people with TFA had osseointegrated press-fit implant. Follow up: 5 years | 34% (20 out of 58) of people had revision surgery. In 12% (7 out of 58), it was due to intramedullary stem failures (6 breakages, 1 septic loosening), and in 22% (13 out of 58) it was due to dual-cone adaptor failure (10 weak-point breakages and 4 distal taper breakages; 1 broke both the weak-point and the dual-cone adapter). Risk factors for implant failure include small stem diameter and high number of infectious events. | Studies reporting similar outcomes added to evidence summary. |
Nebergall A, Bragdon C, Antonellis A et al. (2012) Stable fixation of an osseointegated implant system for above-the-knee amputees: titel RSA and radiographic evaluation of migration and bone remodelling in 55 cases. Acta Orthop. 83(2):121-8. | RSA and periprosthetic bone remodelling study n=51 people with transfemoral amputations (55 implants) had osseointegrated implant system (OPRA). RSA and plain radiographs were scheduled at 6 months and at 1, 2, 5, 7, and 10 years after surgery. | The RSA analysis for the OPRA system indicated stable fixation of the implant. The periprosthetic bone remodelling showed similarities with changes seen around uncemented hip stems. It is a promising approach. | More comprehensive studies added to evidence summary. Radiographic analysis |
Örgel M, Liodakis E, Jaratjitwilai P et al. (2020) Three-year follow-up of changes of cortical bone thickness after implantation of Endo-Exo-Prosthesis (EEP) for transfemoral amputees. J Orthop Surg Res. 4;15(1):164. | Retrospective cohort study N=37 people with transfemoral amputations had (40 implants -EEP) Follow up: 3 years | Results did not show any significant difference in cortical thickness after implantation. Hypertrophy could be confirmed for 42.5% and atrophy for 37.5%. Some remodelling of the has been reported. | Changes in cortical bone thickness More comprehensive studies added to evidence summary. |
Örgel M, Aschoff HH, Sedlacek L et al. (2022) Analysis of Stomal Bacterial Colonialization After Transcutaneous Osseointegrated Prosthetic Systems Surgery. JAMA Netw Open. 1;5(7): e2223383. | Prospective cohort study N=66 above-knee TFAs had TOPs surgery-EEP. | Most bacteria on the stoma of people undergoing TOPS surgery were gram positive. Authors could not detect specific bacterial pathogens prospectively. | Stomal bacterial colonisation after surgery. More comprehensive studies added to evidence summary. |
Örgel M, Aschoff HH, Sedlacek L et al. (2022) Twenty-four months of bacterial colonialization and infection rates in patients with transcutaneous osseointegrated prosthetic systems after lower limb amputation-A prospective analysis. Front Microbiol.13:1002211. | Prospective cohort study N=66 people with lower-limb amputations (transfemoral) had TOPS surgery -EEP. | Gram-positive bacteria in the stoma of TOPS people were noted over 24 months. This could be a protective factor for ascending periprosthetic infections and could possibly explain the relatively low infection rates. | Bacterial colonisation of the stoma. More comprehensive studies added to evidence summary. |
Örgel M, Schwarze F, Graulich T et al. (2022) Comparison of functional outcome and patient satisfaction between patients with socket prosthesis and patients treated with transcutaneous osseointegrated prosthetic systems (TOPS) after transfemoral amputation. Eur J Trauma Emerg Surg. 48(6):4867-4876. | Retrospective comparative analysis n = 69 people with TFA had prosthesis (n=36 socket group and n=33 TOPS group) follow up 1 year | Study showed significantly higher scores for mobility and satisfaction. This demonstrates the high potential of TOPS in the prosthetic treatment of people with TFA with regard to their functional abilities in daily life. | More comprehensive studies added to evidence summary. |
Örgel M, Elareibi M, Graulich T et al. (2023) Osseoperception in transcutaneous osseointegrated prosthetic systems (TOPS) after transfemoral amputation: a prospective study. Arch Orthop Trauma Surg.143(2):603-610. | Prospective case-control study N=75 people 25 people with EEP, 25 people with socket prostheses, and 25 healthy volunteers. | Significant level of differences in tactile osseoperception between all groups noted (p<0.001). EEP can lead to an improvement in tactile sensory perception, QOL and gait safety. | Osseoperception More comprehensive studies added to evidence summary. |
Pantall A, Durham S, Ewins D. (2011) Surface electromyographic activity of 5 residual limb muscles recorded during isometric contraction in transfemoral amputees with osseointegrated prostheses. Clin Biomech. 26(7):760-5. | Preliminary study on transfemoral amputees (n=5) with osseointegrated implant (OPRA) with a control group (n=10) assessed surface EMG patterns. | High electromyographic amplitude variability suggests that using residuum muscles singly as a myoprocessor might be challenging. Adductor magnus displayed a different surface EMG profile compared with intact subjects indicating decreased function and neuromuscular changes. | Electromyographic activity assessed. More comprehensive studies added to evidence summary. |
| Cross-sectional study N=39 people with TFA treated with osseointegration (n=22 endo-exo prosthesis) to socket (n=17) prosthesis users. Follow up: 1 year | People with osseointegration had less prosthesis-associated problems than socket-prosthesis users and had a higher QOL (Q-TFA scores). General QOL (EQ-5D-3L), was not different between groups. | More comprehensive studies added to evidence summary. |
Ranaldi S, Naaim A, Marchis C, Robert T, Dumas R, Conforto S, Frossard L. Walking ability of individuals fitted with transfemoral bone-anchored prostheses: A comparative study of gait parameters. Clin Rehabil. 2023 Dec;37(12):1670-1683. | Retrospective cross-sectional comparative study. N=17 8 people with transfemoral bone-anchored prostheses OPRA versus 9 people with socket prostheses | Bone-anchored and socket-suspended prostheses restored equally well the gait parameters at a self-selected speed. This benchmark data provides new insights into the walking ability of people using transfemoral bionics bone-anchored prostheses. | Gait parameters More comprehensive studies added to evidence summary. |
Ranker A, Oergel M, Aschoff HH et al. (2021) Preoperative femoral abduction angle correlates with initial postoperative lateral hip pain after transcutaneous osseointegrated prosthetic system (TOPS) in transfemoral amputees. Eur J Orthop Surg Traumatol. 31(6):1225-1233. | Retrospective analysis Pre- and postoperative long-leg radiographs of 18 unilateral above-knee amputees treated with TOPS (press-fit system) were retrospectively measured after 4 weeks. | The preoperative femoral abduction angle (FAA) strongly correlates with postoperative lateral hip pain (LHP). High risk of LHP can limit prosthetic training and should be realised in the decision meeting. Pre-rehabilitative reduction of the FAA should be taken into consideration. | Radiographic analysis More comprehensive studies added to evidence summary. |
Reif TJ, Khabyeh-Hasbani N, Jaime KM et al. (2021) Early Experience with Femoral and Tibial Bone-Anchored Osseointegration Prostheses. JB JS Open Access. 6(3): e21.00072. | Retrospective case series N=31 people who underwent implantation of a press-fit osseointegration implant of the femur (18) or tibia (13) with follow up of at least 6 months. Mean follow up: 21.1 months. | Osseointegration implants improved the overall and functional experience of people compared with socket prosthetics. Complications were present but manageable and were not a deterrent to ongoing support of the technology. | More comprehensive studies added to evidence summary. |
Reetz D, Atallah R, Mohamed J et al. (2020) Safety and Performance of Bone-Anchored Prostheses in Persons with a Transfemoral Amputation: A 5-Year Follow-up Study. J Bone Joint Surg Am. 5;102(15):1329-1335. | Retrospective cohort study n=39 people with TFAs had implantation of a press-fit osseointegration implant. Follow up: 5 years. | Patient prosthetic use and HRQOL improved significantly. Grade-1 and 2 infections were frequent but could be treated. Two broken intramedullary stems were revised successfully. | More comprehensive studies added to evidence summary. |
Sinclair S, Beck JP, Webster J et al. (2022) The First FDA Approved Early Feasibility Study of a Novel Percutaneous Bone Anchored Prosthesis for Transfemoral Amputees: A Prospective 1-year Follow-up Cohort Study. Arch Phys Med Rehabil.103(11):2092-2104 | Prospective cohort study N=10 people with unilateral TFA had press-fit POP and a minimum of 10 days supervised rehabilitation therapy. Follow up: 1 year | Improvements in bone density, function, and PROs were observed with the POP device when compared with a socket suspension system. This feasibility study established safety and effectiveness of the POP device, supporting further investigation. | More comprehensive studies added to evidence summary. |
Saleib MM, Van Lieshout EMM, Verduin D et al. (2023) Activities of daily living in lower limb amputees with a bone-anchored prosthesis: a retrospective case series with 24 months' follow up. Acta Orthop. 10; 94:499-504. | Retrospective case series N=48 people who had transfemoral (n=40) or trans-tibial (n=8) amputations had bone-anchored prosthesis (BAP- OPL press-fit) 24 months follow up. | Objective measurements on activities of daily living positively changed in people with BAP. This effect was also seen in mobility and walking ability at 24 months. | More comprehensive studies added to evidence summary. |
Stenlund P, Kulbacka-Ortiz K, Jönsson S et al. (2019) Loads on Trans-humeral Amputees Using Osseointegrated Prostheses. Ann Biomed Eng. 47(6):1369-1377. | Case series N=11 trans-humeral amputees with osseointegrated implants. | The study shows the diversity and uncertainty that exist in a population of trans-humeral amputees treated with bone-anchored prostheses in terms of loading in daily life. | More comprehensive studies added to evidence summary. |
Sullivan J, Uden M, Robinson KP et al. (2003) Rehabilitation of the trans-femoral amputee with an osseointegrated prosthesis: the United Kingdom experience. Prosthetics and Orthotics International 27: 114–20. | Case series N=11 people with transfemoral osseointegrated prostheses. Follow up: 5.5 years | Direct skeletal attachment has led to improvement in candidates' comfort, function and QOL. Importance of an assessment to explore candidates' suitability and expectations for the procedure is discussed. | Study included in systematic reviews added to evidence summary. |
Tillander J, Hagberg K, Berlin Ö et al. (2017) Osteomyelitis risk in patients with transfemoral amputations treated with osseointegration prostheses. Clin Orthop Relat Res. 475(12):3100-3108 | Retrospective cohort study n= 96 people with TFA receiving femoral implants -OPRA (102 implants, implant time 95 months) | Implant-associated osteomyelitis was reported in 16 people corresponding to a 10-year cumulative risk of 20% (95% CI 0.12-0.33). Ten implants were extracted owing to osteomyelitis, with a 10-year cumulative risk of 9% (95% CI 0.04-0.20). | Study included in systematic reviews added to evidence summary. |
Tillander J, Hagberg K, Hagberg L, Brånemark R. Osseointegrated titanium implants for limb prostheses attachments: infectious complications. Clin Orthop Relat Res. 2010 Oct;468(10):2781-8. | Prospective cohort study N=39 people with arm and leg amputations fitted with transcutaneous osseointegrated titanium implants-OPRA (33 femoral, 1 tibial, 4 ulnar, 4 radial, and 3 humeral implants). Follow up: mean 56 months (range 132 to 133 months). | Infection was 5% at inclusion and 18% at follow up. One patient with infection recovered with antibiotic treatment and another patient had the implant removed. The most common bacteria in superficial and deep cultures were Staphylococcus aureus and coagulase-negative staphylococci. | Study included in systematic reviews added to evidence summary. |
Thesleff A, Brånemark R, Hakansson N et al. (2018) Biomechanical Characterisation of Bone-anchored Implant Systems for Amputation Limb Prostheses: A Systematic Review. Annals of Biomedical Engineering, 46, 3, 377–391. | Systematic review of the biomechanical characteristics of current percutaneous implant systems for direct skeletal attachment of amputation limb prostheses. | Although there are large differences between current implant systems, the 3 clinically available systems (OPRA, ILP, and OPL) have shown functional improvements for people. Recent developments of implant systems, surgical protocols, and safety devices have reduced the rate of mechanical failure and infectious complications. | More comprehensive studies added to evidence summary. |
Thomson S, Lu W, Zreiqat H et al. (2019) Proximal Bone Remodeling in lower limb amputees reconstructed with an osseointegrated prosthesis. J Orthop Res. 37(12):2524-2530. | Prospective cohort study n=48 unilateral amputees who received an osseointegrated implant-OPL/ILP (33 transfemoral amputees and 15 trans-tibial amputees) underwent DXA scans of the lumbar spine (L2-L4) and femoral necks at baseline, 1- and 3-years follow ups. | Results suggest that osseointegrated implants induce a physiological response in the femoral neck of recipients and appear to be evidence of restored biomechanical loading in the proximal femur. | Bone mineral density changes assessed. More comprehensive studies added to evidence summary. |
Van Eck CF, and R. L. Mcgough. Clinical outcome of osseointegrated prostheses for lower extremity amputations: A systematic review of the literature. Curr. Orthop. Pract. 26:349–357, 2015. | Systematic review 13 studies (540 people) 3 prospective, 7 retrospective cohort studies, 3 retrospective comparative studies (OIP versus socket prosthesis) Devices used: EEP in 5 studies, OPRA in 7 studies and ITAP in 1 study. Mainly TFAs. Follow up varied in studies (from 6 months to 15 years) | 82% to 90% of people used prosthesis daily. 95% of people were happy with osseointegrated prosthesis. SF-36 and Q-TFA scores were satisfactory. There was a high complication rate, including skin problems (30% to 54%), skin infections (28% to 55%), implant infections (2% to 41%), loosening (2% to 6%), periprosthetic fracture (0% to 9%), revision surgery (8% to 67%), and explants (3% to 20%). | More comprehensive studies added to evidence summary. |
Van de Meent H, Hopman MT, Frölke JP. (2013) Walking ability and quality of life in subjects with transfemoral amputation: a comparison of osseointegration with socket prostheses. Arch Phys Med Rehabil. 94 (11):2174-8. | Prospective case-control study. N=22 with TFA (1 bilateral) had ILP implanted. Follow up: 1 year | Osseointegration is a suitable intervention for persons whose prosthesis use is reduced because of socket-related problems. Subjects with OIP significantly increased their walking ability and prosthesis-related QOL. | Study included in systematic reviews added to evidence summary. |
Welke B, Hurschler C, Schwarze M et al. (2023) Comparison of conventional socket attachment and bone-anchored prosthesis for persons living with transfemoral amputation - mobility and quality of life. Clin Biomech. 105:105954. | Cross-sectional study N=37 people with unilateral TFAs (20 with a BAP were compared with 17 with a socket prosthesis) | There were no differences between the groups regarding the QOL, daily mobility, and gait performance. For people who are satisfied with the socket treatment and perform well, BAP may not improve their functional capabilities and QOL. | More comprehensive studies added to evidence summary. |
Zaid MB, OʼDonnell RJ, Potter BK et al. (2019) Orthopaedic Osseointegration: State of the Art. J Am Acad Orthop Surg. 15;27(22): e977-e985 | Review on history, indications, contraindications, implant systems in use, and reported outcomes. | Osseointegration offers the potential for enhanced biomechanical advantage and rehabilitative potential. Multiple percutaneous implant systems exist for clinical use internationally, each attempting to create a stable bone-implant interface while avoiding complications such as infection and loosening. | Review |
How are you taking part in this consultation?
You will not be able to change how you comment later.
You must be signed in to answer questions