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.
研究组 & 干预措施
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.
干预措施: Collagen Scaffold (Colla-Plug) (Device)
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.
干预措施: microfracture (Procedure)
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.
干预措施: microfracture (Procedure)
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
- Disabilities of the Arm, Shoulder and Hand(DASH)(Preoperatively, 1st week, 1st month, 3rd month, and 6th month postoperatively)
- 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)
- 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