Achilles Tendon Rupture Clinical Trial
Official title:
Outcomes Evaluation of Endoscopic Flexor Hallucis Longus Transfer Versus Minimally Invasive Primary Repair in Patients With Acute Achilles Tendon Rupture
Verified date | November 2023 |
Source | Aristotle University Of Thessaloniki |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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?
Status | Enrolling by invitation |
Enrollment | 40 |
Est. completion date | September 30, 2025 |
Est. primary completion date | September 30, 2024 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
Greece | General Hospital of Naoussa | Náousa | Central Macedonia |
Lead Sponsor | Collaborator |
---|---|
Aristotle University Of Thessaloniki | General Hospital of Naoussa, Private Orthopedics Practice P. Symeonidis |
Greece,
Abdelatif NMN, Batista JP. Endoscopic Flexor Hallucis Longus Transfer for the Management of Acute Achilles Tendon Ruptures in Professional Soccer Players. Foot Ankle Int. 2022 Feb;43(2):164-175. doi: 10.1177/10711007211036439. Epub 2021 Sep 24. — View Citation
Abdelatif NMN, Batista JP. Outcomes of Percutaneous Achilles Repair Compared With Endoscopic Flexor Hallucis Longus Tendon Transfer to Treat Achilles Tendon Ruptures. Foot Ankle Int. 2022 Sep;43(9):1174-1184. doi: 10.1177/10711007221096674. Epub 2022 Jun — View Citation
Batista JP, Abdelatif NMN, Del Vecchio JJ, Diniz P, Pereira H. Endoscopic Flexor Hallucis Longus Transfer for the Management of Acute Achilles Tendon Ruptures: A Prospective Case Series Report With a Minimum of 18 Months' Follow-Up. J Foot Ankle Surg. 202 — View Citation
Martin KD, Crouser NJ, Khan IA. Minimally Invasive Mid-Substance Achilles Tendon Repair Using the Percutaneous Achilles Repair System (PARS). JBJS Essent Surg Tech. 2022 Sep 22;12(3):e21.00050. doi: 10.2106/JBJS.ST.21.00050. eCollection 2022 Jul-Sep. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Complication Rate | Complications will be recorded and categorized: Rerupture, Infection, Nerve injury, Miscellaneous | More than 12 months postoperatively | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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