A Study of Collagen Scaffold for the Repair of Elbow Cartilage Injury

Phase 3Not Yet RecruitingNCT07149896

Beijing Jishuitan Hospital90 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Cartilage Defect Elbow Injury

Interventions

Collagen Scaffold (Colla-Plug)DEVICE

The collagen cartilage scaffold(COLTRIX® CartiRegen) used in this study consist of an injection needle, a syringe, and a collagen gel prefilled in a syringe. The collagen gel contains phosphate buffer and type Ⅰ collagen which the telopeptides are removed.. After the product is implanted in the body, it forms a degradable three-dimensional scaffold to provide an environment for cells to adhere, proliferate, migrate, differentiate and secrete, thereby promoting cartilage repair. At present, it has been commercially applied to clinical repair of knee cartilage defect.

microfracturePROCEDURE

Microfracture to repair cartilage defect is a minimally invasive procedure that is usually done arthroscopically. The doctor first cleans the damaged cartilage area, and then uses a special microfracture cone to drill vertically in the subchondral bone plate, forming multiple tiny holes, allowing mesenchymal stem cells and growth factors in the bone marrow to overflow, forming a blood clot rich in repair components, and finally stimulating fibrocartilage regeneration to fill the defect area.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Subjects are between the ages of 18 and 55 (including 18 and 55 years old); 2. Articular cartilage defect reaches Outerbridge grade III/IV; 3. The area of cartilage defect in a single site is 0.5cm²-2cm²; 4. BMI 18≤BMI≤30; 5. Clinically diagnosed cartilage defect requiring arthroscopic microfracture; 6. Have not participated in other clinical trials within 3 months; 7. Conservative treatment such as rest/topical/oral non-steroidal anti-inflammatory drugs for more than 3 months has not been effective 8. Subjects fully understand the benefits and risks of this trial, are willing to participate and sign the informed consent form, and are able to cooperate with clinical follow-up. Exclusion Criteria: 1. Obvious narrowing of the elbow joint space or bone ankylosis formed between joints; 2. Severe subchondral bone injury that cannot be undergoing microfracture surgery; 3. Those with severe elbow deformity or systemic osteoarticular diseases; 4. Secondary elbow arthritis with psoriasis, syphilitic neuropathy, brown yellow disease, metabolic bone disease; 5. Elbow joint cartilage damage caused by joint fractures, infections, tumors, and immune diseases; 6. Elbow joint tumors, rheumatoid, tuberculosis, suppuration and complications affecting the joint structure; 7. Those who have undergone cartilage defect transplantation from bone marrow mesenchymal stem cell transplantation or other cartilage regeneration surgery within 12 months before surgery; 8. Allergies, such as porcine protein allergy, past history or family history of autoimmune diseases; 9. Those who regularly use sedatives, sleeping pills, tranquilizers or other addictive drugs; 10. Combined with cardiovascular, cerebrovascular, liver, kidney and hematopoietic system and other serious primary diseases, mental illness; 11. Those who cannot receive long-term and complex rehabilitation training after surgery; 12. Women who are planning to have children, breastfeeding and pregnant women within 12 months; 13. Those who have contraindications to MRI examination; 14. Those who have special beliefs and cannot accept it (the product source is pig source); 15. Those who are not suitable for inclusion by other researchers, such as those who cannot be judged for efficacy.

Outcomes

Primary Outcomes

MOCART(Magnetic Resonance Observation of Cartilage Repair Tissue) score

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).

Time frame: Preoperatively, 3rd and 6th months postoperatively

Secondary Outcomes

Visual Analogue Scale(VAS)

The VAS scoring system is a standardized subjective symptom assessment tool designed based on the principle of visual simulation, with a core form of a 10 cm long straight line, with a minimum score of 0 (representing no symptoms) and a maximum value of 10 (representing the most severe symptoms), with higher scores indicating more severe symptoms.