NCT06641401Enrolling By Invitation不适用
A Case Series of Endoscopic Flexor Hallucis Longus Transfer for Acute Achilles Tendon Rupture.
适应症
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Patient Satisfaction
研究概览
简要总结
This observational study aims to evaluate the outcome of endoscopic flexor hallucis longus transfer (FHLt) in patients with acute Achilles tendon rupture (AATR).
详细描述
This evaluation will be performed by examining the following parameters:
- Patient satisfaction quantified with the Achilles tendon Total Rupture Score (ATRS). This is the primary outcome.
- Complication rate
- Ankle and Calf circumference compared to the contralateral healthy limb.
- Passive and Active range of ankle motion compared to the contralateral healthy limb.
- Hallux flexion force compared to the contralateral healthy limb.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 18 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed Consent Form
- •Acute Achilles Tendon Rupture (<4 weeks)
- •Underwent operative treatment with Endoscopic Flexor Hallucis Longus transfer
- •More than 24 months postoperative follow-up
- •Patients operated after 2015
排除标准
- •Inability or Unwillingness to cooperate
- •Medically unfit for examination
- •Age less than 18 or more than 75 years
- •Non-operative Management or any other Surgical Management
- •Neglected Achilles Tendon Rupture (>4 weeks)
- •Bilateral Achilles Tendon Rupture
- •Patients operated before 1.1.2015 or after 1.1.2023
- •Comorbidities interfering with the secondary outcomes (e.g. Venous insufficiency resulting in lower limb excessive edema interferes with ankle and calf circumference, rheumatoid arthritis and/or previous foot and ankle surgery interferes with active and passive range of motion of the ankle, etc)
结局指标
主要结局
Patient Satisfaction
时间窗: At least 24 months postoperatively
Evaluated and quantified with the Achilles Tendon Total Rupture Score (min = 0 - worst outcome, max = 100 - best outcome)
次要结局
- Complication rate(At least 24 months postoperatively)
- Calf Circumference(At least 24 months postoperatively)
- Ankle Circumference(At least 24 months postoperatively)
- Ankle Range of Motion(At least 24 months postoperatively)
研究者
Michail Kotsapas
Michail Kotsapas, MD, MSc, Resident of Orthopedics (General Hospital of Naoussa), PhD Candidate (Aristotle University of Thessaloniki)
Aristotle University Of Thessaloniki
研究点 (1)
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