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

Beijing Jishuitan Hospital

Status and phase: Not yet enrolling; Phase 3

Conditions: Cartilage Defect; Elbow Injury

Treatments: Procedure: microfracture; Device: Collagen Scaffold (Colla-Plug)

Study type: Interventional

Funder types: Other

Identifiers

NCT07149896

K20250509-02

Details and patient eligibility

About

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

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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90 participants in 2 patient groups

Microfracture + Collagen scaffold

Experimental group

Description:

After performing arthroscopic microfracture (with a cone tip spacing of 2-3mm and a depth reaching the subchondral bone), the defect site is dried using a suction tube and cotton swabs. A double-chamber syringe is used to inject the collagen scaffold, which will be then shaped and cured. Afterward, physiological saline is reinfused, and the stability of the graft is assessed under arthroscopy during the full range of motion of the elbow joint.

Treatment:

Device: Collagen Scaffold (Colla-Plug)

Procedure: microfracture

Microfracture

Active Comparator group

Description:

Conventional arthroscopic microfracture operation is carried out, and the operation process of the experimental group is simulated by simulated drying and lavage during the operation.

Treatment:

Procedure: microfracture