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

Официальное название

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

Обзор

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

Вмешательства

• Устройство 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
• Процедура 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.

Первичные конечные точки

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

Вторичные конечные точки (6)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Beijing Jishuitan Hospital Affiliated to Capital Medical University — Пекин

Публикации

• 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

Идентификаторы

NCT: NCT07149896 · K20250509-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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