2025 ISAKOS Congress in Munich, Germany

2025 ISAKOS Biennial Congress Paper


First-in-Human Study of Biomimetic Synthetic Cartilage Implant To Treat Painful Knee Cartilage Leasions

Marcin E. Domzalski, MD, Prof., Konstantynów Lódzki, lódzkie POLAND
Sabrina M. Strickland, MD, New York, NY UNITED STATES
Andreas H. Gomoll, MD, New York, NY UNITED STATES
Deryk G. Jones, MD, Jefferson, LA UNITED STATES
Urszula E. Zdanowicz, MD, Warsaw POLAND
Dennis Charles Crawford, MD, PhD, Portland, OR UNITED STATES

Multicenter Study, LODZ, NEW YORK, OREGON, WARSAW, POLAND

FDA Status Cleared

Summary

Preliminary first-in-human results suggest that immediate restoration of the joint surface with a biomimetic synthetic cartilage implant may quickly relieve pain and return function while using a joint preserving technique to precisely address specific pathology in a wide range of patients suffering from knee osteochondral lesions.

Abstract

FDA STATUS Investigational use only

SUMMARY
A precisely engineered biphasic, biomimetic synthetic cartilage implant has demonstrated both preliminary safety and efficacy with rapid pain relief and improvement in joint function in a first-in-human trial.

Background

Knee osteochondral lesions can result in recalcitrant pain and loss of function for a broad patient population. Regenerative cartilage repair approaches can have limited availability and lengthy, variable healing. Synthetic cartilage repair implants based on traditional metals or polymers significantly differ from cartilage mechanical properties and are associated with implant failure along with further adverse joint changes. There is a need for a biomimetic synthetic osteochondral implant that is both robust in strength and matches joint surface properties. This study presents first-in-human experience with an off-the-shelf implant comprised of a hydrated polymer that mimics the structure and function of hyaline cartilage, secured via a porous titanium subchondral base. This construct is specifically designed to address cartilage loss and disease with associated subchondral pathology.

Purpose

Report initial safety and clinical experience with a synthetic implant system for replacement of cartilage and bone, evaluated during a first-in-human study.

Methods

A prospective, multi-center, single-arm, first-in-human study was conducted (clinicaltrials.gov/study/NCT06368700; clinicaltrials.gov/study/NCT06344481). The study population consisted of 13 patients 30-64 years of age, BMI ≤ 35, with painful knee femoral condyle osteochondral lesions (ICRS Grade 3-4). Subjects underwent single stage arthroscopic evaluation and when eligible, same surgery implantation of the biphasic, biomimetic device using a mini arthrotomy. Rehabilitation was analogous to typical osteochondral transplant rehabilitation protocols, with gradual return to full weightbearing. Standard primary safety outcome metrics, e.g. incidence of device-related adverse events, were closely monitored. The primary performance outcome measure was a clinically significant change in mean Knee Injury and Osteoarthritis Outcome score (KOOS) relative to pre-operative baseline. Two year follow up is planned.

Results

Thirteen of 13 patients were successfully implanted with the device. The surgical technique provided efficient, reproducible site preparation and device placement, with mean implant time of 7.6 minutes (range 4-14) and surgical time (from completion of arthroscopy) of 20.5 minutes (range 12-29). There were no reported procedural or device-related adverse events. At six weeks (n=11), patients had minimal pain and joint swelling, unrestricted range of motion and full weight bearing. By three months, patients (n=7) reported mean 31 (±23) and 29 (±23) point improvements in total KOOS score and KOOS pain subscore, respectively, over pre-operative baseline scores. At six months, patient results (n=4) showed mean 30 (±18) and 29 (±19) point improvements in total KOOS score and KOOS pain subscore, respectively, relative to baseline. Pain subscore improvements exceeded the clinically important difference of 8.3 points. Subsequently enrolled patients (n=2) are showing consistent recovery patterns. There were no reoperations or radiographic evidence of implant migration.

Conclusions

Preliminary first-in-human results suggest that immediate restoration of the joint surface with a biomimetic synthetic cartilage implant may quickly relieve pain and return function while using a joint preserving technique to precisely address specific pathology in a wide range of patients suffering from knee osteochondral lesions.