Study to Evaluate a New Cartilage Regeneration Platform for Knee Cartilage Repair
A Prospective, Randomized, Multicenter, Open-Label, Assessor-Blinded, Parallel-Group Clinical Trial to Compare the Efficacy and Safety of Microfracture Alone Versus Microfracture Combined With a Cartilage Regeneration Platform in Patients With Knee Cartilage Defects
ROKIT Healthcare
104 participants
Dec 29, 2025
INTERVENTIONAL
Conditions
Summary
The goal of this clinical trial is to learn if a new treatment works to help regrow knee cartilage in people with knee cartilage damage. The main questions it aims to answer are: Does the treatment help the knee work better and lower pain more than the standard surgery? Is the treatment safe and does it help grow stronger new cartilage? Researchers will compare participants who get the standard surgery (microfracture) to participants who get both the standard surgery and the new treatment. This is to see if the new treatment leads to a better and faster recovery. Participants will: Have a surgery to treat their knee cartilage damage. Visit the clinic for check-ups to see how well their knee moves. Take imaging tests, like an MRI, so researchers can look at the new cartilage.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
This intervention is a multi-step, autologous tissue-based regenerative procedure. Arthroscopic debridement is first performed at the focal cartilage defect. Microfracture is then performed at the defect bed according to standard technique. Infrapatellar fat pad (IFP) tissue is subsequently harvested through a small incision. The harvested autologous tissue is processed intra-operatively to generate micronized autologous ECM and prepared as a printable formulation. A patient-specific patch is fabricated using a 3D bioprinting system and implanted to cover the focal cartilage defect. The study evaluates patch integration and regenerative outcomes following implantation.
This intervention consists of arthroscopic debridement of the focal cartilage defect followed by microfracture performed at the defect bed according to standard technique. The study evaluates clinical and structural outcomes following microfracture.
Locations(13)
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NCT07639424