Chronic Insertional Achilles Tendonitis Treated With or Without Flexor Hallucis Longus Tendon Transfer: A Prospective, Randomized, Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- ankle plantar flexion strength measured using a handheld dynamometer
研究概览
简要总结
The purpose of this study is to determine whether Achilles tendon debridement and decompression augmented with flexor hallucis longus (FHL) tendon transfer results in improved clinical and functional outcome as measured by ankle plantar flexion strength and American Orthopedic Foot and Ankle Society (AOFAS) score compared to debridement and decompression alone in patients over 50 years of age with chronic insertional Achilles tendinosis.
H0: There will be no difference in ankle plantar flexion strength measured using a handheld dynamometer between patients randomized to achilles tendon decompression and debridement alone (Group 1) and patients randomized to achilles tendon decompression and debridement augmented with FHL transfer (Group 2).
HA: Patients randomized to achilles tendon decompression and debridement alone (Group 1) will have less ankle plantar flexion strength compared to patients randomized to achilles tendon decompression and debridement augmented with FHL transfer (Group 2).
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
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 50 years of age or older
- •Patients diagnosed with chronic insertional Achilles tendonitis
- •Failed greater than 3 months of conservative treatment (activity and shoe modification, heel lifts, non-steroidal anti-inflammatory medications, stretching exercises, and formal physical therapy)
排除标准
- •Patients less than 50 years of age upon presentation
- •Females of child-bearing potential
- •Patients who have a history of ipsilateral Achilles tendon rupture
- •History of infection in the same lower extremity
- •Patients unable to undergo MRI scan
结局指标
主要结局
ankle plantar flexion strength measured using a handheld dynamometer
时间窗: pre-operatively, 3 months, 6 months, and 1 year
次要结局
- American Orthopaedic Foot and Ankle Society(AOFAS) Ankle-Hindfoot score(pre-operatively, 3 months, 6 months, and 1 year)
- Visual analog pain scale (VAS)(pre-operatively, 3 months, 6 months, and 1 year)
- Hallux plantarflexion strength using the dynamometer(pre-operatively, 3 months, 6 months, and 1 year)
- Patient Satisfaction(1 year)
- Surgical complications(Date of Surgery)
- Postoperative complications(3 months, 6 months, and 1 year)