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

    The content on this page is not current guidance and is only for the purposes of the consultation process.

    Appendix

    The following table outlines the studies that are considered potentially relevant to the IP overview but were not included in the summary of the key evidence. It is by no means an exhaustive list of potentially relevant studies.

    Additional papers identified

    Article

    Number of patients/ follow up

    Direction of conclusions

    Reasons for non-inclusion in summary of key evidence section

    Al-Bayati M, Martinez-Carranza N, Roberts D et al. (2021) Good subjective outcome and low risk of revision surgery with a novel customized metal implant for focal femoral chondral lesions at a follow-up after a minimum of 5 years. Archives of Orthopaedic and Trauma Surgery

    n=10

    FU=75 months

    A good subjective outcome, a low risk of progression to degenerative changes and the need for subsequent surgery were seen at the mid-term follow-up with the Episealer customised focal knee-resurfacing implant.

    Studies with more people or longer follow up are included.

    Becher C, Kalbe C, Thermann H et al. (2011) Minimum 5-year results of focal articular prosthetic resurfacing for the treatment of full-thickness articular cartilage defects in the knee. Archives of orthopaedic and trauma surgery 131(8):1135-43

    n=21

    FU=5.3 years

    HemiCAP appears to be an effective reconstructive treatment option for large full-thickness cartilage and osteochondral lesions of the knee in middle-aged people.

    Studies with more people or longer follow up are included. Revision rates reported by Elbardesy (2021).

    Becher C and Cantiller EB. (2017) Focal articular prosthetic resurfacing for the treatment of full-thickness articular cartilage defects in the knee: 12-year follow-up of two cases and review of the literature. Archives of orthopaedic and trauma surgery 137(9):1307-17

    n=2

    FU=12 years

    Twelve-year follow up of 2 cases treated with the HemiCAP implant. Results suggest that focal articular prosthetic resurfacing is an effective and safe treatment option in selected cases.

    Studies with more people included. Revision rates reported by Elbardesy (2021).

    Beyzadeoglu T and Pehlivanoglu T. (2018) Biological Response Following Inlay Arthroplasty of the Knee: Cartilage Flow Over the Implant. Cartilage 9(2):156-60

    n=35 people, 41 knees

    FU=14 months

    Joint surface reconstruction using the HemiCAP implant showed stable fixation with peripheral cartilage coverage ranging from 9% to 20% and no further chondral damage on opposing surfaces.

    Studies with more people or longer follow up are included.

    Bollars P, Bosquet M, Vandekerckhove B et al. (2012) Prosthetic inlay resurfacing for the treatment of focal, full thickness cartilage defects of the femoral condyle: a bridge between biologics and conventional arthroplasty. Knee surgery, sports traumatology, arthroscopy: official journal of the ESSKA 20(9):1753-9

    n=19

    FU=34 months

    Focal femoral condyle resurfacing demonstrated excellent results for pain and function in middle-aged, well selected people with full thickness cartilage and osteochondral defects. Patient profiling and assessment of confounding factors, mechanical joint alignment; meniscal function; and healthy opposing cartilage surfaces, are important for an individual treatment approach and successful outcomes.

    Studies with more people or longer follow up are included. Revision rates reported by Elbardesy (2021).

    Cases E, Natera L, Anton C et al. (2020) Focal inlay resurfacing for full-thickness chondral defects of the femoral medial condyle may delay the progression to varus deformity. European journal of orthopaedic surgery & traumatology: orthopedie traumatologie 31(1):57-63

    n=10

    FU=9 years

    In the setting of small to moderate size, unique femoral medial condyle full-thickness chondral lesions, filling the defect with an inlay prosthetic resurfacing may protect against the progression to varus deformity.

    Studies with more people included.

    Davidson PA and Rivenburgh D. (2008) Focal Anatomic Patellofemoral Inlay Resurfacing: Theoretic Basis, Surgical Technique, and Case Reports. Orthopedic Clinics of North America 39(3):337-46

    n=2

    FU=3 months

    Both people treated with the HemiCAP patellofemoral implant had successful outcomes.

    Studies with more people or longer follow up are included.

    Defrere J and Franckart A. (1992) Teflon/polyurethane arthroplasty of the knee: the first 2 years preliminary clinical experience in a new concept of artificial resurfacing of full thickness cartilage lesions of the knee. Acta chirurgica Belgica 92(5):217-27

    n=23 people, 37 implants

    FU=2 years

    Teflon/polyurethane composite implant was successful as a prosthetic knee resurface implant and demonstrates good biocompatibility. However, the use of unicompartmental bipolar implants should be avoided.

    Studies with more people or longer follow up are included.

    Dhollander AAM, Almqvist KF, Moens K et al. (2015) The use of a prosthetic inlay resurfacing as a salvage procedure for a failed cartilage repair. Knee surgery, sports traumatology, arthroscopy:official journal of the ESSKA 23(8):2208-2212

    n=14

    FU=26.1 months

    The HemiCAP resurfacing system is feasible as a salvage treatment for a failed index cartilage procedure and resulted in a gradual clinical improvement. However, the favourable clinical outcome was not confirmed by the radiographical findings.

    Studies with more people or longer follow up are included. Revision rates reported by Elbardesy (2021).

    Fuchs A, Eberbach H, Izadpanah K et al. (2018) Focal metallic inlay resurfacing prosthesis for the treatment of localized cartilage defects of the femoral condyles: a systematic review of clinical studies. Knee surgery, sports traumatology, arthroscopy: official journal of the ESSKA 26(9):2722-32

    n=6 studies, 186 people

    FU=ranged from 2 to 7 years

    Focal metallic inlay resurfacing prosthesis seems to be a viable option for a carefully selected group of people. Significant improvement in knee function and pain was observed in most people, though 20% needed to be converted to arthroplasty after 4 years. Uncertainty remains about progression of osteoarthritis because of conflicting results and inconsistent reporting. Lower rates of revision were seen with the UniCAP implant than the smaller HemiCAP implant.

    More recent systematic review included.

    Hobbs H, Ketse-Matiwane N, van der Merwe W et al. (2013) Focal full thickness articular cartilage lesions treated with an articular resurfacing prosthesis in the middle-aged. SA Orthopaedic Journal.

    n=22

    FU=4.7 years

    HemiCAP articular resurfacing is an effective treatment option for pain in the middle-aged patient with a focal articular cartilage defect in the knee.

    Studies with more people or longer follow up are included. Revision rates reported by Elbardesy (2021).

    Jeuken RM, van Hugten PPW, Roth AK et al. (2021) A Systematic Review of Focal Cartilage Defect Treatments in Middle-Aged Versus Younger Patients. Orthopaedic Journal of Sports Medicine 9(10)

    n=2 studies

    Two studies were included that used the Episealer implant – Martinez-Carranza (2020) and Holz (2021). Both found statistically significant improvements in patient-reported outcome measures.

    More recent systematic review included. Holz (2021) included.

    Laursen JO. (2017) 3-Year Clinical Result of a Customized Metal Mini-Prosthesis for Focal Chondral Lesion in The Knee Of A Formerly Active 31-Year-Old Man. Journal of Exercise, Sports & Orthopedics 2(4):1-3

    n=1

    FU=3 years

    A case of a 31-year-old formerly active man. Focal condyle cartilage lesion did not respond to microfracture. Use of Episealer to repair lesion was successful over 3 years follow-up.

    Studies with more people or longer follow up are included.

    Laursen JO and Lind M. (2017) Treatment of full-thickness femoral cartilage lesions using condyle resurfacing prosthesis. Knee surgery, sports traumatology, arthroscopy: official journal of the ESSKA 25(3):746-51

    n=61

    FU=2 years

    This study demonstrated improved subjective outcome and reduced pain after femoral resurfacing using the HemiCAP implant in a relatively large

    cohort of people with symptomatic cartilage lesions. A 23% reoperation rate with conversion to

    arthroplasty was found.

    Studies with more people or longer follow up are included. Revision rates reported by Elbardesy (2021).

    Laursen JO. (2016) Treatment of full-thickness cartilage lesions and early OA using large condyle resurfacing prosthesis: UniCAP(R). Knee surgery, sports traumatology, arthroscopy: official journal of the ESSKA 24(5):1695-701

    n=64

    FU=2 years

    This study demonstrated an improved subjective outcome and reduced pain after femoral resurfacing using the UniCAP implant in a relatively large cohort of people with symptomatic large cartilage lesions or early OA. A 47% reoperation rate with conversion to arthroplasty was found.

    Studies with more people or longer follow up are included. Revision rates reported by Elbardesy (2021).

    Laursen JO, Mogensen CB, and Skjot-Arkil H. (2019) HemiCAP Knee Implants: Mid- to Long-Term Results. Cartilage.

    n=62

    FU=7.3 years

    This study found good clinical and radiographic outcomes, and for those people who did not require revisions, there were long-term improvements in disability and function.

    Studies with more people or longer follow up included. Revision rates reported by Elbardesy (2021).

    Laursen JO, Backer Mogensen C, and Skjot-Arkil H. (2019) UniCAP offers a long-term treatment for middle-aged patients, who are not revised within the first 9 years. Knee surgery, sports traumatology, arthroscopy: official journal of the ESSKA 27(5):1693-7

    n=64

    FU=mean 7.2 years, max 9 years

    There was a survival rate of approximately 40% after 9 years of follow-up, but in the group of people (35 to 65 years old) not eligible for a final total arthroplasty. These people were often left with pain and disability. This implant can be a temporary or even long-term treatment because it improved the disability and function over the long-term without a major progression in the osteoarthritis, function or pain

    High dropout rate, studies with more people or longer follow up included.

    Laursen JO, Mogensen CB, Skjot-Arkil H et al. (2020) A long-term prospective follow-up study of resurfacing mini-prosthesis suitable for patients above sixty-five years with localized cartilage lesions or early osteoarthritis in the knee. Journal of Experimental Orthopaedics 7(1):96

    n=23

    FU=9.6 years

    HemiCAP/UniCAP implant treatment for early OA in people older than 65 years can require revision to knee arthroplasty in 30% of people. But in people that are not revised, long-term improvements in subjective clinical

    outcome was demonstrated.

    Studies with more people included. Incomplete follow-up (10 people).

    Malahias MA, Thorey F, and Chytas D. (2018) The clinical outcome of the different hemiCAP and uniCAP knee implants: A systematic and comprehensive review. Orthopedic Reviews 10(2):58-64

    n=10 studies

    FU=2 to 7 years

    The progression of osteoarthritis, the persisting pain and the subsequent high revision or failure rates in the limited available studies with long-term follow-up, seem to be the major drawbacks of partial resurfacing techniques. Utilisation of partial resurfacing for femoral or patellofemoral compartments results in good short-term outcome for middle-aged people as a step between biological technique and total knee arthroplasty.

    More recent systematic review included.

    Martinez-Carranza N, Rockborn P, Roberts D et al. (2020) Successful Treatment of Femoral Chondral Lesions with a Novel Customized Metal Implant at Midterm Follow-Up. Cartilage

    n=30

    FU=55 months

    This customized resurfacing metal implant showed good safety and patient satisfaction. The risk of osteoarthritis progression and implant loosening is low. Subjective function and pain improved significantly.

    Studies with more people or longer follow up are included.

    Moewis P, Kaiser R, Trepczynski A et al. (2021) Patient-specific resurfacing implant knee surgery in subjects with early osteoarthritis results in medial pivot and lateral femoral rollback during flexion: a retrospective pilot study. Knee surgery, sports traumatology, arthroscopy: official journal of the ESSKA.

    n=10

    FU=1 year

    A clear physiological knee kinematics pattern of medial pivot, lateral femoral rollback and coupled axial external femoral rotation during flexion was observed in patients treated with an Episealer resurfacing procedure. However, higher femoral rollback and axial external rotation in comparison to healthy knees was observed, suggesting possible post-operative muscle weakness and consequent insufficient stabilization at high flexion.

    Studies with more people or longer follow up are included.

    Nahas S, Monem M, Li L et al. (2020) Ten-Year Average Full Follow-up and Evaluation of a Contoured Focal Resurface Prosthesis (HemiCAP) in Patients in the United Kingdom. The journal of knee surgery 33(10):966-70

    n=14

    FU=8.9 years

    This series demonstrates

    that focal resurfacing is a safe, suitable, and useful temporising step in knee

    arthroplasty surgery. The use of the focal resurfacing implant in this way allows the delay

    in transition to knee arthroplasty. This series shows an excellent functional outcome for

    remaining implants at average 10 years, with low complication rates.

    Studies with more people are included. Revision rates reported by Elbardesy (2021).

    Pascual-Garrido C, Daley E, Verma NN, and Cole BJ. (2017) A Comparison of the Outcomes for Cartilage Defects of the Knee Treated With Biologic Resurfacing Versus Focal Metallic Implants. Arthroscopy: the journal of arthroscopic & related surgery: official publication of the Arthroscopy Association of North America and the International Arthroscopy Association 33(2):364-73

    n=32

    FU=2 years

    Careful person selection can achieve high satisfaction rates with both biological and focal metal resurfacing procedures for the treatment of isolated focal chondral lesions of the femoral condyle in the knee. Focal metallic resurfacing results in similar clinical outcomes and provides excellent success rates at short-term follow-up.

    Studies with more people or longer follow up are included. Revision rates reported by Elbardesy (2021).

    Stålman A, Skoldenberg O, Martinez-Carranza N et al. (2018) No implant migration and good subjective outcome of a novel customized femoral resurfacing metal implant for focal chondral lesions. Knee surgery, sports traumatology, arthroscopy: official journal of the ESSKA 26(7):2196-204

    n=10

    FU=2 years

    The short-term Episealer implant safety and patient-related outcome measures showed good-to-excellent results.

    Studies with more people or longer follow up are included.

    van Buul GM, Headon R, O'Toole G et al. (2020) Does resurfacing of asymptomatic full-thickness localized articular defects of the trochlear influence the outcome following unicompartmental knee arthroplasty of the medial compartment?: A retrospective cohort study with minimum seven-year follow-up.

    The Knee 27(5):1492-1500

    n=30

    FU=97.4 months

    This study found a 100% survivorship of the HemiCAP PFC implant at an average 8-year follow-up. However, no clinical benefits were found in performing trochlear resurfacing in conjunction with medial unicompartmental knee arthroplasty for asymptomatic end-stage trochlear cartilage lesions. Therefore, these lesions can be safely

    ignored when performing a medial UKA.

    Studies with more people or longer follow up are included. All people also had unicompartmental knee arthroplasty.

    Abbreviations: FU, follow-up.