A Study of Collagen Scaffold for the Repair of Elbow Cartilage Injury
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-55
SponsorBeijing Jishuitan Hospital
About this trial
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
Eligibility criteria
Qualifiers
Subjects are between the ages of 18 and 55 (including 18 and 55 years old);
Articular cartilage defect reaches Outerbridge grade III/IV;
The area of cartilage defect in a single site is 0.5cm²-2cm²;
BMI 18≤BMI≤30;
Disqualifiers
Obvious narrowing of the elbow joint space or bone ankylosis formed between joints;
Severe subchondral bone injury that cannot be undergoing microfracture surgery;
Those with severe elbow deformity or systemic osteoarticular diseases;
Secondary elbow arthritis with psoriasis, syphilitic neuropathy, brown yellow disease, metabolic bone disease;
Trial design
Treatments tested in this trial
- Collagen Scaffold (Colla-Plug)
- microfracture
Treatment groups
90 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov