A Prospective Randomized Controlled Study Of Collagen Scaffold For The Repair Of Elbow Cartilage Injury
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- MOCART(Magnetic Resonance Observation of Cartilage Repair Tissue) score
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
MOCART(Magnetic Resonance Observation of Cartilage Repair Tissue) score
时间窗: Preoperatively, 3rd and 6th months postoperatively
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).
次要结局
- 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)
- Rate of Complications(Preoperatively, 1st week, 1st month, 3rd month, and 6th month postoperatively)
研究者
Yi Lu
Chief physician
Beijing Jishuitan Hospital