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Enrolling by invitation NCT06114368

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

— Observational Achilles Tendon Rupture Achilles Tendon Surgery Achilles Tendon Injury

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Surgery for the treatment of Acute Achilles tendon rupture.
Who it may be relevant to
Registry conditions: Achilles Tendon Rupture, Achilles Tendon Surgery, Achilles Tendon Injury. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Greece
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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

Primary outcome measures

  • Patient Satisfaction assessed with the Achilles Tendon Total Rupture Score [Time frame: More than 12 months postoperatively]
Secondary outcome measures (4)
  • Complication Rate [Time frame: More than 12 months postoperatively]
  • Calf Circumference [Time frame: More than 12 months postoperatively]
  • Ankle Circumference [Time frame: More than 12 months postoperatively]
  • Ankle joint Range of Motion [Time frame: More than 12 months postoperatively]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

Greece · 1 center
  • General Hospital of Naoussa — Náousa

Publications

  • 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 10. PMID 35686445
  • 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. PMID 34558318
  • 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. 2020 Sep-Oct;59(5):927-937. doi: 10.1053/j.jfas.2019.12.008. Epub 2020 Jun 9. PMID 32527698
  • 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. PMID 36816527

Identifiers

NCT: NCT06114368 · 26543

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗