PMID- 33025052 OWN - NLM STAT- MEDLINE DCOM- 20210826 LR - 20220724 IS - 1433-7347 (Electronic) IS - 0942-2056 (Print) IS - 0942-2056 (Linking) VI - 29 IP - 9 DP - 2021 Sep TI - Patient-specific metal implants for focal chondral and osteochondral lesions in the knee; excellent clinical results at 2 years. PG - 2899-2910 LID - 10.1007/s00167-020-06289-7 [doi] AB - PURPOSE: Surgical treatment options for the management of focal chondral and osteochondral lesions in the knee include biological solutions and focal metal implants. A treatment gap exists for patients with lesions not suitable for arthroplasty or biologic repair or who have failed prior cartilage repair surgery. This study reports on the early clinical and functional outcomes in patients undergoing treatment with an individualised mini-metal implant for an isolated focal chondral defect in the knee. METHODS: Open-label, multicentre, non-randomised, non-comparative retrospective observational analysis of prospectively collected clinical data in a consecutive series of 80 patients undergoing knee reconstruction with the Episealer(R) implant. Knee injury and Osteoarthritis Outcome Score (KOOS) and VAS scores, were recorded preoperatively and at 3 months, 1 year, and 2 years postoperatively. RESULTS: Seventy-five patients were evaluated at a minimum 24 months following implantation. Two patients had undergone revision (2.5%), 1 declined participation, and 2 had not completed the full data requirements, leaving 75 of the 80 with complete data for analysis. All 5 KOOS domain mean scores were significantly improved at 1 and 2 years (p < 0.001-0.002). Mean preoperative aggregated KOOS4 of 35 (95% CI 33.5-37.5) improved to 57 (95% CI 54.5-60.2) and 59 (95% CI 55.7-61.6) at 12 and 24 months respectively (p < 0.05). Mean VAS score improved from 63 (95% CI 56.0-68.1) preoperatively to 32 (95% CI 24.4-38.3) at 24 months. The improvement exceeded the minimal clinically important difference (MCID) and this improvement was maintained over time. Location of defect and history of previous cartilage repair did not significantly affect the outcome (p > 0.05). CONCLUSION: The study suggests that at 2 years, Episealer(R) implants are safe with a low failure rate of 2.5% and result in clinically significant improvement. Individualised mini-metal implants with appropriate accurate guides for implantation appear to have a place in the management of focal femoral chondral and osteochondral defects in the knee. LEVEL OF EVIDENCE: IV. CI - (c) 2020. The Author(s). FAU - Holz, Johannes AU - Holz J AD - OrthoCentrum Hamburg, Hansastrasse 1-3, 20149, Hamburg, Germany. dr.holz@oc-h.de. FAU - Spalding, Tim AU - Spalding T AUID- ORCID: 0000-0002-9856-8387 AD - Department Trauma and Orthopaedics, University Hospital Coventry, Clifford Bridge Road, Coventry, UK. FAU - Boutefnouchet, Tarek AU - Boutefnouchet T AD - Department Trauma and Orthopaedics, University Hospital Coventry, Clifford Bridge Road, Coventry, UK. FAU - Emans, Pieter AU - Emans P AD - Department of Orthopaedics, Maastricht UMC+, P. Debyelaan 25, 6229 HX, Maastricht, The Netherlands. FAU - Eriksson, Karl AU - Eriksson K AD - Department of Orthopaedics, Stockholm South Hospital, Karolinska Institutet, Sjukhusbacken 10, 118 83, Stockholm, Sweden. FAU - Brittberg, Mats AU - Brittberg M AD - Cartilage Research Unit, University of Gothenburg, Region Halland Orthopaedics, Kungsbacka Hospital, 434 80, Kungsbacka, Sweden. FAU - Konradsen, Lars AU - Konradsen L AD - Department of Orthopaedic Surgery, Bispebjerg Hospital, Bispebjerg Bakke 23, 2400, Bispebjerg, Denmark. FAU - Kosters, Clemens AU - Kosters C AD - Clinic for Orthopaedics, Trauma and Hand Surgery, Maria-Josef-Hospital Greven, Lindenstr. 29, 48268, Greven, Germany. FAU - Verdonk, Peter AU - Verdonk P AD - Orthoca, AZ Monica Hospitals, Harmoniestraat 68, 2018, Antwerp, Belgium. FAU - Hogstrom, Magnus AU - Hogstrom M AD - Sports Medicine Umea AB and Orthopedics, Department of Surgical and Perioperative Sciences, Umea University, 901 87, Umea, Sweden. FAU - Lind, Martin AU - Lind M AD - Deptartment of Orthopedics, Aarhus University Hospital, Palle Juul Jensens Boulevard 99, 8200, Arhus, Denmark. LA - eng PT - Journal Article PT - Multicenter Study PT - Observational Study DEP - 20201006 PL - Germany TA - Knee Surg Sports Traumatol Arthrosc JT - Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA JID - 9314730 SB - IM MH - *Cartilage Diseases/surgery MH - *Cartilage, Articular/surgery MH - Follow-Up Studies MH - Humans MH - Knee Joint/surgery MH - Minimal Clinically Important Difference MH - Retrospective Studies PMC - PMC8384793 OTO - NOTNLM OT - Clinical outcomes OT - Customised OT - Focal cartilage lesion OT - Focal knee resurfacing OT - Metal implants OT - Personalized COIS- Four authors on the paper are members of the Consultant Advisory Board for Episurf, manufacturer of the implant in the paper (TS, JH, MB, KE). There are no other conflicts. EDAT- 2020/10/08 06:00 MHDA- 2021/08/27 06:00 PMCR- 2020/10/06 CRDT- 2020/10/07 05:52 PHST- 2020/06/01 00:00 [received] PHST- 2020/09/14 00:00 [accepted] PHST- 2020/10/08 06:00 [pubmed] PHST- 2021/08/27 06:00 [medline] PHST- 2020/10/07 05:52 [entrez] PHST- 2020/10/06 00:00 [pmc-release] AID - 10.1007/s00167-020-06289-7 [pii] AID - 6289 [pii] AID - 10.1007/s00167-020-06289-7 [doi] PST - ppublish SO - Knee Surg Sports Traumatol Arthrosc. 2021 Sep;29(9):2899-2910. doi: 10.1007/s00167-020-06289-7. Epub 2020 Oct 6.