A Randomized, Controlled Clinical Trial to Evaluate the Effect on Patient Outcomes of Weight Bearing Status After Forage of Osteochondral Defects of the Ankle
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Ankle Osteoarthritis Scale
研究概览
简要总结
The rationale for this research study is to evaluate the effect on clinical outcomes of weight bearing as tolerated after forage surgery for the treatment of osteochondral defects of the ankle, thus potentially eliminating the need for a period of immobilisation or non-weight bearing after surgery.
The investigators hypothesize that their will be no difference in functional outcomes between weight bearing as tolerated as compared to non-weight bearing for six weeks after forage surgery for OCD of the ankle.
详细描述
The hypothesis for advantage of the investigational post-operative therapy is based on:
Equivalent clinical outcomes to non-weight bearing; Similar radiographic findings on CT at follow-up visit between the two groups; reduced morbidity and disability to subjects through elimination of a period of non-weight bearing; reduction of cost to patients by eliminating need for adjuvant walking and mobility aids (crutches, taxis) and time off work.
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
- 16 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients aged 16-60 years
- •No prior ankle surgery
- •Able and willing to comply with follow-up
- •Capable of provide informed consent
- •Medically fit for surgery
- •Lesions on preoperative CT Scan < 1.5cm
- •Symptomatic (ie:pain, restricted activities, inability to WB, decreased ROM)
- •Single Isolated lesion
- •Failure of conservative treatment (3 months of limited activities and/or weight bearing and/or immobilization)
排除标准
- •Age less than 16 years or greater than 60 years
- •Inflammatory arthritis
- •Diffuse osteoarthritis of affected joint
- •Associated fracture
- •Prior ankle surgery for current injury (including arthroscopy)
- •Unable to comply with follow-up
- •Unable to provide informed consent
- •Bernt & Hardy class IV (amenable to ORIF)
- •Multiple osteochondral defects in one ankle or touching osteochondral lesions of tibia and talus
- •Prior osteochondral defects of the affected ankle
研究组 & 干预措施
Non-Weight Bearing x 6 weeks
Immediate Weight-Bearing as Tolerated
干预措施: Weight-Bearing as Tolerated (Other)
结局指标
主要结局
Ankle Osteoarthritis Scale
时间窗: 12 months
Pain and disability outcomes assessed on scale of 1-100. The higher the score is more pain\\disability
次要结局
- CAT Scan(12months)