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临床试验/NCT06114368
NCT06114368Enrolling By Invitation不适用

Outcomes Evaluation of Endoscopic Flexor Hallucis Longus Transfer Versus Minimally Invasive Primary Repair in Patients With Acute Achilles Tendon Rupture

Aristotle University Of Thessaloniki1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年3月5日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
40
试验地点
1
主要终点
Patient Satisfaction assessed with the Achilles Tendon Total Rupture Score

研究概览

简要总结

The goal of this observational study is to compare the outcomes of two different surgical techniques (Endoscopic Flexor Hallucis Longus transfer - Group 1 vs Minimally Invasive primary repair - Group 2) for patients with acute Achilles tendon rupture. The main questions to be answered are:

  1. Which group's patients are more satisfied?
  2. Which group's patients appear to have a greater complication rate?
  3. Which group's patients have greater calf and ankle circumference compared to the unaffected limb?
  4. Which group's patients have greater passive and active range of ankle motion compared to the unaffected limb?
  5. Are group 1 patients characterized by strength deficit in hallux flexion power?

详细描述

Two separate foot and ankle surgeons in Northern Greece prefer to use a different surgical technique in their respective patients with Acute Achilles tendon rupture.

The first one (A.E.) prefers to perform only Endoscopic Flexor Hallucis Longus transfer, while the second one (P.S.) prefers to perform only Minimally invasive primary repair assisted by the Achillon device (Percutaneous Achilles Repair System - PARS). They both agreed to enroll their recently operated patients (last 5 years) in this retrospective study, which will be conducted by the researcher (M.K.). The patient's study may be retrospective, nevertheless, the patients were randomly chosen and enrolled by a prospectively designed study protocol. Each surgeon applied the respective surgical treatment modality regardless of each patient's characteristics, biometrics, or comorbidities. Inclusion and Elimination criteria will be applied. The patient's satisfaction will be evaluated with the Achilles Tendon Total Rupture Score (ATRS). Complications will be documented. Calf and ankle circumference will be measured and compared to the contralateral healthy limb. Ankle passive and active range of motion will be measured and compared to the contralateral healthy limb. Possible correlations will be investigated regarding patient age, BMI, history of smoking, level of activity, and comorbidities.

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 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Signed Consent Form
  • Age between 18-75 years
  • Acute Achilles Tendon Rupture (<3 weeks)
  • Surgical Management with Endoscopic Flexor Hallucis Longus transfer or Minimally Invasive primary tendon repair
  • More than 12 months postoperative follow-up
  • Patients operated after 2015

排除标准

  • Inability or Unwillingness to cooperate
  • Medically unfit for examination (e.g. due to terminal illness)
  • Age less than 18 or more than 75 years
  • Non-operative Management as definitive treatment
  • Surgical Management other than the ones described in the inclusion criteria
  • Neglected Achilles Tendon Rupture (>3 weeks)
  • Bilateral Achilles Tendon Rupture
  • Patients operated before 2015
  • 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 assessed with the Achilles Tendon Total Rupture Score

时间窗: More than 12 months postoperatively

Evaluated and quantified with the Achilles Tendon Total Rupture Score (minimum value = 0 - worst outcome, maximal value = 100 - best outcome)

次要结局

  • Complication Rate(More than 12 months postoperatively)
  • Calf Circumference(More than 12 months postoperatively)
  • Ankle Circumference(More than 12 months postoperatively)
  • Ankle joint Range of Motion(More than 12 months postoperatively)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

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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