Evaluation of the Effectiveness and Safety of Autologous Costal Osteochondral Transplantation in the Treatment of Talar Osteochondral Lesions: a Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- American Orthopedic Foot and Ankle Society (AOFAS) ankle-hindfoot scale score
研究概览
简要总结
The goal of this clinical trial is to evaluate the effectiveness and safety of autologous costal osteochondral transplantation in the treatment of Hepple Stage V talar osteochondral lesions, compared with autologous osteoperiosteal transplantation. The main question it aims to answer is:
• Whether autologous costal osteochondral transplantation can achieve better clinical outcomes and cartilage repair quality with lower donor site morbidity than autologous osteoperiosteal transplantation in the treatment of Hepple Stage V talar osteochondral lesions.
Participants will be randomly assigned to the intervention group (undergoing autologous costal osteochondral transplantation) or the control group (undergoing autologous osteoperiosteal transplantation). Both groups of participants will receive the same postoperative rehabilitation process and follow-up evaluation.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic Hepple stage V talar osteochondral lesions with a lesion depth ≥5 mm and an AOFAS score ≤80 points;
- •Failed conservative treatment for at least 6 months;
- •Unilateral talar osteochondral lesions without corresponding lesions on the tibial side;
- •Willingness to participate in this clinical trial and signing an informed consent form.
排除标准
- •Combined with lower limb deformity.
- •Combined with hip or knee joint diseases.
- •Combined with ipsilateral ankle arthritis with joint space narrowing .
- •Diagnosis of gouty arthritis of the ankle joint.
- •Combined with osteoporosis (T score <-2.5).
- •Other conditions considered inappropriate for participation in this clinical trial by the researchers.
结局指标
主要结局
American Orthopedic Foot and Ankle Society (AOFAS) ankle-hindfoot scale score
时间窗: 24 months after surgery
0-100
次要结局
- Foot and Ankle Ability Measure (FAAM) ADL subscale(12 and 24 months after surgery)
- International Cartilage Repair Society (ICRS) score(12 months after surgery)
- Tegner score(12 and 24 months after surgery)
- Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) score(12 and 24 months after surgery)
- American Orthopedic Foot and Ankle Society (AOFAS) ankle-hindfoot scale score(3, 6, 12 months after surgery)
- Foot and Ankle Ability Measure (FAAM) Sports subscale(12 and 24 months after surgery)
- Bone union(3 months after surgery or later)
- Any other complications(1, 2, 3, 6, 12 and 24 months after surgery)
- Numeric Rating Scale (NRS) for ankle pain during walking(3, 6, 12 and 24 months after surgery)
- Patients' satisfaction degree(24 months after surgery)
- Numeric Rating Scale (NRS) for donor-site pain(1, 2, 3, 6, 12 and 24 months after surgery)
研究者
Canjun Zeng
Director of the Department of Foot and Ankle Surgery
The Third Affiliated Hospital of Southern Medical University