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

NCT07149896 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: K20250509-02
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cartilage Defect; Elbow Injury

Keywords

elbow cartilage defect; collagen scaffold

Outcome Measures

Primary Outcomes (1)

• 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).

  Preoperatively, 3rd and 6th months postoperatively

Secondary Outcomes (6)

• Visual Analogue Scale(VAS)

  Preoperatively, 1st week, 1st month, 3rd month, and 6th month postoperatively

• Mayo Elbow Performance Score(MEPS)

  Preoperatively, 1st week, 1st month, 3rd month, and 6th month postoperatively

• Oxford Elbow Score(OES)

  Preoperatively, 1st week, 1st month, 3rd month, and 6th month postoperatively

• Disabilities of the Arm, Shoulder and Hand(DASH)

  Preoperatively, 1st week, 1st month, 3rd month, and 6th month postoperatively

• Range of motion

  Preoperatively, 1st week, 1st month, 3rd month, and 6th month postoperatively

Study Arms (2)

Microfracture + Collagen scaffold

EXPERIMENTAL

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.

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

Microfracture

ACTIVE COMPARATOR

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.

Procedure: microfracture

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.

Microfracture + Collagen scaffold

microfracture 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; Microfracture + Collagen scaffold

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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;
• Clinically diagnosed cartilage defect requiring arthroscopic microfracture;
• Have not participated in other clinical trials within 3 months;
• Conservative treatment such as rest/topical/oral non-steroidal anti-inflammatory drugs for more than 3 months has not been effective
• 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.

You may not qualify if:

• 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;
• Elbow joint cartilage damage caused by joint fractures, infections, tumors, and immune diseases;
• Elbow joint tumors, rheumatoid, tuberculosis, suppuration and complications affecting the joint structure;
• Those who have undergone cartilage defect transplantation from bone marrow mesenchymal stem cell transplantation or other cartilage regeneration surgery within 12 months before surgery;
• Allergies, such as porcine protein allergy, past history or family history of autoimmune diseases;
• Those who regularly use sedatives, sleeping pills, tranquilizers or other addictive drugs;
• Combined with cardiovascular, cerebrovascular, liver, kidney and hematopoietic system and other serious primary diseases, mental illness;
• Those who cannot receive long-term and complex rehabilitation training after surgery;
• Women who are planning to have children, breastfeeding and pregnant women within 12 months;
• Those who have contraindications to MRI examination;
• Those who have special beliefs and cannot accept it (the product source is pig source);

Sponsors & Collaborators

• Beijing Jishuitan Hospital: lead

Study Sites (1)

Beijing Jishuitan Hospital Affiliated to Capital Medical University

Beijing, Beijing Municipality, 100035, China

Location

Related Publications (4)

• Shetty AA, Kim SJ, Bilagi P, Stelzeneder D. Autologous collagen-induced chondrogenesis: single-stage arthroscopic cartilage repair technique. Orthopedics. 2013 May;36(5):e648-52. doi: 10.3928/01477447-20130426-30.

  PMID: 23672920 BACKGROUND

• Shetty AA, Kim SJ, Shetty V, Jang JD, Huh SW, Lee DH. Autologous collagen induced chondrogenesis (ACIC: Shetty-Kim technique) - A matrix based acellular single stage arthroscopic cartilage repair technique. J Clin Orthop Trauma. 2016 Jul-Sep;7(3):164-9. doi: 10.1016/j.jcot.2016.05.003. Epub 2016 Jun 14.

  PMID: 27489411 BACKGROUND

• Kim SJ, Shetty AA, Kurian NM, Ahmed S, Shetty N, Stelzeneder D, Shin YW, Cho YJ, Lee SH. Articular cartilage repair using autologous collagen-induced chondrogenesis (ACIC): a pragmatic and cost-effective enhancement of a traditional technique. Knee Surg Sports Traumatol Arthrosc. 2020 Aug;28(8):2598-2603. doi: 10.1007/s00167-020-05884-y. Epub 2020 Feb 17.

  PMID: 32064573 BACKGROUND

• Jeong IH, Shetty AA, Kim SJ, Jang JD, Kim YJ, Chung YG, Choi NY, Liu CH. Autologous collagen-induced chondrogenesis using fibrin and atelocollagen mixture. Cells Tissues Organs. 2013;198(4):278-88. doi: 10.1159/000356488. Epub 2013 Dec 20.

  PMID: 24356241 BACKGROUND

MeSH Terms

Conditions

Elbow Injuries

Interventions

Arthroplasty, Subchondral

Condition Hierarchy (Ancestors)

Arm Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures

Central Study Contacts

Yi Lu

CONTACT

86-010-57801282; luyi_sports@126.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: July 23, 2025
• First Posted: September 2, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 2, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

CN (1)