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

Study Overview
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Brief Summary
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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: Which group's patients are more satisfied? Which group's patients appear to have a greater complication rate? Which group's patients have greater calf and ankle circumference compared to the unaffected limb? Which group's patients have greater passive and active range of ankle motion compared to the unaffected limb? Are group 1 patients characterized by strength deficit in hallux flexion power?

Detailed Description
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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.

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

Conditions
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Achilles Tendon Rupture, Achilles Tendon Surgery, Achilles Tendon Injury

Intervention / Treatment
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* Procedure: Surgery for the treatment of Acute Achilles tendon rupture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Endoscopic Flexor Hallucis Longus transfer / Group 1<br>Patients with acute Achilles tendon rupture managed with Endoscopic Flexor Hallucis Longus transfer by one surgeon (A.E.) in one hospital (General Hospital of Naoussa, Naoussa, Greece), all of which followed the same rehabilitation protocol. | Procedure: Surgery for the treatment of Acute Achilles tendon rupture<br>* Two different surgical techniques were applied in two different patient groups for the same disease. Their outcomes are evaluated and compared<br>|
| Minimally Invasive Primary repair / Group 2<br>Patients with acute Achilles tendon rupture managed with Minimally Invasive Primary repair by one surgeon (P.S.) in one hospital (St. Luke's Hospital, Thessaloniki, Greece), all of which followed the same rehabilitation protocol. | Procedure: Surgery for the treatment of Acute Achilles tendon rupture<br>* Two different surgical techniques were applied in two different patient groups for the same disease. Their outcomes are evaluated and compared<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Satisfaction assessed with the Achilles Tendon Total Rupture Score | Evaluated and quantified with the Achilles Tendon Total Rupture Score (minimum value = 0 - worst outcome, maximal value = 100 - best outcome) | More than 12 months postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication Rate | Complications will be recorded and categorized: Rerupture, Infection, Nerve injury, Miscellaneous | More than 12 months postoperatively | 
| Calf Circumference | 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. | More than 12 months postoperatively | 
| Ankle Circumference | 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. | More than 12 months postoperatively | 
| Ankle joint Range of Motion | 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. | More than 12 months postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rupture, Achilles tendon, Endoscopic, Flexor Hallucis Longus transfer, repair, Percutaneous Achilles Repair System - PARS, Minimally invasive