NCT06114368

Brief Summary

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. 1.Which group's patients are more satisfied?
  2. 2.Which group's patients appear to have a greater complication rate?
  3. 3.Which group's patients have greater calf and ankle circumference compared to the unaffected limb?
  4. 4.Which group's patients have greater passive and active range of ankle motion compared to the unaffected limb?
  5. 5.Are group 1 patients characterized by strength deficit in hallux flexion power?

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 5, 2023

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 28, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 2, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2026

Completed
Last Updated

October 15, 2024

Status Verified

October 1, 2024

Enrollment Period

2.1 years

First QC Date

October 28, 2023

Last Update Submit

October 12, 2024

Conditions

Achilles Tendon RuptureAchilles Tendon SurgeryAchilles Tendon Injury

Keywords

Achilles tendonruptureEndoscopicFlexor Hallucis Longus transferrepairPercutaneous Achilles Repair System - PARSMinimally invasive

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Complication Rate

    More than 12 months postoperatively

  • Calf Circumference

    More than 12 months postoperatively

  • Ankle Circumference

    More than 12 months postoperatively

  • Ankle joint Range of Motion

    More than 12 months postoperatively

Study Arms (2)

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.

Procedure: Surgery for the treatment of Acute Achilles tendon rupture

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.

Procedure: Surgery for the treatment of Acute Achilles tendon rupture

Interventions

Surgery for the treatment of Acute Achilles tendon rupturePROCEDURE

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

Endoscopic Flexor Hallucis Longus transfer / Group 1Minimally Invasive Primary repair / Group 2

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with Achilles tendon rupture operated exclusively with these two surgical techniques, by these two particular surgeons (A.E. and P.S.) in their respective hospitals (General Hospital of Naoussa, St Luke's Hospital).

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General Hospital of Naoussa

Náousa, Central Macedonia, 59200, Greece

Location

Related Publications (4)

  • 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: 35686445RESULT

  • 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: 34558318RESULT

  • 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: 32527698RESULT

  • 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: 36816527RESULT

MeSH Terms

Conditions

Rupture

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Michail K. Kotsapas, MD, MSc

    Aristotle University Of Thessaloniki

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Michail Kotsapas, MD, MSc, Resident of Orthopedics (General Hospital of Naoussa), PhD Candidate (Aristotle University of Thessaloniki)

Study Record Dates

First Submitted

October 28, 2023

First Posted

November 2, 2023

Study Start

March 5, 2023

Primary Completion

March 30, 2025

Study Completion

March 30, 2026

Last Updated

October 15, 2024

Record last verified: 2024-10

Locations

GR(1)