Differential analysis of the impact of lesions' location on clinical and radiological outcomes after the implantation of a novel aragonite-based scaffold to treat knee cartilage defects.

Purpose: There is limited comparative evidence on patient outcomes following cartilage repair in various knee compartments. The aim of this study was to compare clinical and imaging outcomes after treating cartilage defects in femoral condyles and trochlea with either an aragonite-based scaffold or surgical standard of care (SSoC, i.e., debridement/microfractures) in a large multicentre randomized controlled trial.
Methods: 247 patients with up to three knee joint surface lesions (ICRS grade IIIa or above) in the femoral condyles, trochlea or both ("mixed"), were enrolled and randomized to surgery with either a cell-free aragonite scaffold or SSoC. Patients were followed for up to 48 months by analysing subjective scores (KOOS and IKDC), radiological outcomes (defect filling on MRI), as well as treatment failure rates and adverse events. A differential analysis of outcomes for condylar, trochlear and mixed lesions was performed.
Results: The scaffold group significantly outperformed the SSoC group regardless of lesion location with statistically significantly better KOOS Overall scores at 24 months (all p ≤ 0.0009) and 48 months (all p ≤ 0.02). Similar results were observed for KOOS subscales and IKDC scores. For KOOS responder rates, superiority of the implant group was demonstrated at 24, 36, and 48 months (all p ≤ 0.004). Higher defect filling on MRI for implants was observed for all locations. Lower treatment failure rates for the implant were observed in condylar and mixed lesions.
Conclusion: The aragonite-based scaffold was safe and effective regardless of the defect location, providing superior clinical and radiological outcomes compared to SSoC up to four years follow-up.
Level of Evidence: I - Randomized controlled trial.
Competing Interests: Declarations Compliance with ethical standards All performed procedures were in accordance with the ethical standards of the institutional and/or national research committees and with the 1964 Helsinki Declaration and its later. The study was registered on clinicaltrials.gov (NCT: 03299959) and approved by the Food and Drug Administration and each site’s Ethics Committees/Institutional Review Boards. Competing interests P Conte, G Anzillotti, G Fiorentino, DC Crawford, RJ Meislin, EJ Strauss, C Latterman and WE Nordt declare they have no financial interests. V Dasa received research and consulting support from Cartiheal, Bioventus, and Smith and Nephew. J Scopp is a consultant with Arthrex. SM Strickland has received consultant honoraria, research support from Smith and Nephew; received speaker and consultant honoraria as well as research support from Miach, Vericel, Moximed. DC Flanigan is a consultant with Smith and Nephew, Conmed, Depuy Synthes, Nanochon, Hyalex, Moximed, Vericel; he receives research support from Smith and Nephew, Conmed, Depuy Synthes, Episurf, Aesculap, KCRN, Moximed, Vericel.
(© 2024. The Author(s).)