General Hospital of Naoussa
Náousa, Central Macedonia, 59200, Greece
NCT Number: NCT06114368
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?
Interested in participating?
Request Info18 year–75 year
All sexes
Observational
Náousa, Central Macedonia, 59200, Greece
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.
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Two different surgical techniques were applied in two different patient groups for the same disease. Their outcomes are evaluated and compared
Time frame: 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)
Time frame: More than 12 months postoperatively
Complications will be recorded and categorized: Rerupture, Infection, Nerve injury, Miscellaneous
Time frame: More than 12 months postoperatively
Calf circumference measured 15 cm distally to the inferior pole of the patella. Contralateral limb calf circumference will also be measured. The Calf Circumference Difference will be calculated and compared between the two groups.
Time frame: More than 12 months postoperatively
Ankle circumference measured 8 cm proximally to the lateral malleolus. Contralateral limb ankle circumference will also be measured. The Ankle Circumference Difference will be calculated and compared between the two groups.
Time frame: More than 12 months postoperatively
Active and Passive Ankle joint Range of Motion will be calculated with an electronic goniometer. Contralateral limb Range of Ankle joint Motion will also be measured. The Range of Motion Difference will be calculated and compared between the two groups.
Aristotle University Of Thessaloniki
Other
Outcomes Evaluation of Endoscopic Flexor Hallucis Longus Transfer Versus Minimally Invasive Primary Repair in Patients With Acute Achilles Tendon Rupture
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