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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-31

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Autologous Cell-derived Tissue Engineered Cartilage for Repairing Articular Cartilage Lesions

NCT02770209

Cartilage Diseases

UNKNOWN NA

Hydrolyzed Collagen Formulation vs Placebo in Knee Osteoarthritis

NCT04998188

Knee Osteoarthritis

RECRUITING NA

Comparison of Efficacy and Safety of Microfracture and Modified Microfracture

NCT02539030

Defect of Articular Cartilage Osteoarthritis Traumatic Arthritis

UNKNOWN PHASE4

the Efficacy and Safety of a Modified Microfracture Using Collagen Compared to Those of a Simple Microfracture in Ankle

NCT02519881

Defect of Articular Cartilage

UNKNOWN PHASE4

Arthroscopic Autologous Chondrocyte Implantation Versus Microfractures

NCT01947374

Tear; Knee, Cartilage, Articular

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cartilage Defect Elbow Injury

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Microfracture + Collagen scaffold

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.

Group Type EXPERIMENTAL

Collagen Scaffold (Colla-Plug)

Intervention Type 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.

microfracture

Intervention Type PROCEDURE

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.

Microfracture

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.

Group Type ACTIVE_COMPARATOR

microfracture

Intervention Type PROCEDURE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Collagen Scaffold (Colla-Plug)

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.

Intervention Type DEVICE

microfracture

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.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No