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

Official title

A Prospective Randomized Controlled Study Of Collagen Scaffold For The Repair Of Elbow Cartilage Injury

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

Interventions

• Device 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 ha
• Procedure 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.

Primary outcome measures

• MOCART(Magnetic Resonance Observation of Cartilage Repair Tissue) score [Time frame: Preoperatively, 3rd and 6th months postoperatively]

Secondary outcome measures (6)

• Visual Analogue Scale(VAS) [Time frame: Preoperatively, 1st week, 1st month, 3rd month, and 6th month postoperatively]
• Mayo Elbow Performance Score(MEPS) [Time frame: Preoperatively, 1st week, 1st month, 3rd month, and 6th month postoperatively]
• Oxford Elbow Score(OES) [Time frame: Preoperatively, 1st week, 1st month, 3rd month, and 6th month postoperatively]
• Disabilities of the Arm, Shoulder and Hand(DASH) [Time frame: Preoperatively, 1st week, 1st month, 3rd month, and 6th month postoperatively]
• Range of motion [Time frame: Preoperatively, 1st week, 1st month, 3rd month, and 6th month postoperatively]
• Rate of Complications [Time frame: Preoperatively, 1st week, 1st month, 3rd month, and 6th month postoperatively]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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);
• Those who are not suitable for inclusion by other researchers, such as those who cannot be judged for efficacy.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

China · 1 center

• Beijing Jishuitan Hospital Affiliated to Capital Medical University — Beijing

Publications

• 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
• 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
• 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
• 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

Identifiers

NCT: NCT07149896 · K20250509-02

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗