NCT06114368

Endoscopic Flexor Hallucis Longus Transfer vs Minimally Invasive Repair in Acute Achilles Tendon Rupture

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

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 40 (estimated)
• Sponsor: Aristotle University Of Thessaloniki · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: —

Summary

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?

Detailed description

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.

Conditions

• Achilles Tendon Rupture
• Achilles Tendon Surgery
• Achilles Tendon Injury

Interventions

Type	Name	Description
PROCEDURE	Surgery for the treatment of Acute Achilles tendon rupture	Two different surgical techniques were applied in two different patient groups for the same disease. Their outcomes are evaluated and compared

Timeline

• Start date: 2023-03-05
• Primary completion: 2025-03-30
• Completion: 2026-03-30
• First posted: 2023-11-02
• Last updated: 2024-10-15

Locations

1 site across 1 country: Greece