NCT01341509Unknown4 期
Insertional Achilles Tendinopathy: A Randomized Trial to Evaluate the Effectiveness of Transferring the Flexor Hallucis Longus Tendon
适应症
试验速览
- 阶段
- 4 期
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Statistical difference
研究概览
简要总结
The optimal surgical treatment for insertional Achilles tendinopathy remains unclear. The purpose of this study is to evaluate the long-term outcome of surgical treatment by comparing the patient reported outcomes of Insertional Achilles Tendinopathy; Achilles tendon debridement, excision calcaneal exostosis, Strayer procedure, secondary repair of Achilles with flexor hallucis longus (FHL) transfer and Achilles tendon debridement, excision calcaneal exostosis, Strayer procedure, secondary repair of Achilles without FHL transfer.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female 18 years or older
- •Diagnosed with insertional Achilles tendinosis by history and physical exam
- •Confirmed by x-ray and MRI
- •Calcification at the Achilles insertion and gastrocnemius tightness.
- •Failure of the following non-operative treatment for greater than 6 months: *shoe modifications
- •physical therapy
- •immobilization
- •and home exercise program.
- •In addition, participant must have an intact flexor hallucis longus tendon.
排除标准
- •Patients who have failed surgery for the same and patients with diabetic neuropathy.
结局指标
主要结局
Statistical difference
时间窗: 2 years
To detect a 20% difference in clinical outcomes between the two surgical groups.
次要结局
未报告次要终点
研究者
研究点 (2)
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