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

NCT ID: NCT06114368

Last Updated: 2024-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-05

Study Completion Date

2026-03-30

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:

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

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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.

Conditions

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Achilles Tendon Rupture Achilles Tendon Surgery Achilles Tendon Injury

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Endoscopic Flexor Hallucis Longus transfer / Group 1

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.

Surgery for the treatment of Acute Achilles tendon rupture

Intervention Type PROCEDURE

Two different surgical techniques were applied in two different patient groups for the same disease. Their outcomes are evaluated and compared

Minimally Invasive Primary repair / Group 2

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.

Surgery for the treatment of Acute Achilles tendon rupture

Intervention Type PROCEDURE

Two different surgical techniques were applied in two different patient groups for the same disease. Their outcomes are evaluated and compared

Interventions

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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

Intervention Type PROCEDURE

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

* 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)

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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General Hospital of Naoussa

UNKNOWN

Sponsor Role collaborator

Private Orthopedics Practice P. Symeonidis

UNKNOWN

Sponsor Role collaborator

Aristotle University Of Thessaloniki

OTHER

Sponsor Role lead

Responsible Party

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Michail Kotsapas

Michail Kotsapas, MD, MSc, Resident of Orthopedics (General Hospital of Naoussa), PhD Candidate (Aristotle University of Thessaloniki)

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michail K. Kotsapas, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Aristotle University Of Thessaloniki

Locations

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General Hospital of Naoussa

NĂ¡ousa, Central Macedonia, Greece

Site Status

Countries

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Greece

References

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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.

Reference Type RESULT
PMID: 35686445 (View on PubMed)

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.

Reference Type RESULT
PMID: 34558318 (View on PubMed)

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.

Reference Type RESULT
PMID: 32527698 (View on PubMed)

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.

Reference Type RESULT
PMID: 36816527 (View on PubMed)

Other Identifiers

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26543

Identifier Type: -

Identifier Source: org_study_id

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