A Prospective Randomized Controlled Study Of Collagen Scaffold For The Repair Of Elbow Cartilage Injury

NCT07149896 Phase 3 NOT_YET_RECRUITING

The goal of this clinical trial is to test whether adding a collagen protein scaffold can improve cartilage repair in elbow joint injuries, compared to standard surgery alone. The study will enroll 90 patients (aged 18-55) with elbow cartilage damage who haven't responded to conservative treatments. The main questions it aims to answer are: * Does the collagen scaffold help regenerate better-quality cartilage (measured by MRI scans at 3 and 6 months)? * Do patients experience better pain relief and elbow function after this combined treatment? Researchers will compare two groups: * Experimental group : Receives microfracture surgery + collagen scaffold implant * Active Comparator group : Receives microfracture surgery alone Participants will: * Undergo arthroscopic surgery (either procedure) * Complete follow-up visits at 1 week, 1 month, 3 months, and 6 months * Have MRI scans and functional assessments * Report pain levels and daily activity limitations through questionnaires

Details

Lead sponsor	Beijing Jishuitan Hospital
Phase	Phase 3
Status	NOT_YET_RECRUITING
Enrolment	90
Start date	2025-08
Completion	2026-12

Conditions

• Cartilage Defect
• Elbow Injury

Interventions

• Collagen Scaffold (Colla-Plug)
• microfracture

Primary outcomes

• MOCART(Magnetic Resonance Observation of Cartilage Repair Tissue) score — Preoperatively, 3rd and 6th months postoperatively
  The MOCART scoring system is a standardized assessment tool based on magnetic resonance imaging (MRI) specifically designed to quantify the morphological effects after articular cartilage repair. The scoring system uses a 100-point system (minimum score of 0, maximum score of 100), with higher scores representing better repair results. A total score of ≥75 indicates that the repaired tissue is close to normal hyaline cartilage in terms of structure, integration, and signal strength, while a score below 50 indicates poor repair effect or risk of complications. The assessment covered seven core indicators: volume filling of cartilage defects (0-20), integration with adjacent cartilage margins (0-15), repaired tissue surface structure (0-10), repaired tissue structure (0-10), repaired tissue signal intensity (0-15), subchondral bone changes (0-20), and bone quality changes (0-10).

Countries

China