MedTrace Logo

Comparison of Functional Bracing vs Rigid Immobilization After Modified Percutaneous Achilles Tendon Repair

NCT04692883 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL

Last updated 2021-01-05

No results posted yet for this study

Summary

Rationale There is ongoing controversy over the optimal treatment and rehabilitation strategy of an acute Achilles tendon rupture (ATR). The highest general complication rate is reported in patients treated with percutaneous repair and early mobilization.

Objectives The purpose of the study is to compare the results of two ways of postoperative regimen after treatment with the modified and biomechanically significantly stronger percutaneous repair under local anesthesia.

Methods \& Population All the consecutive patients with an acute complete Achilles tendon rupture who will agree to take part in a study will be randomized after a modified percutaneous repair under local anesthesia into functional group (FG), using a modified brace and immobilization group (IG), wearing a rigid plaster, in both groups for the period of 6 weeks. After that they will follow the same (standardized) rehabilitation protocol. Major and minor complication rate, diameter of the healed tendon, active and passive ankle range of motion (using neutral zero method), standing heel-rise test (with 25 repetition within a minute for a grade of normal) and clinical outcome using American Foot and Ankle Society (AOFAS) hindfoot-ankle score, return to the previous activity level, presence of associated complaints and subjective assessment (scored as good, fair or poor) will be assessed.

Time frame This will be a 4-year study with a 3-year follow-up.

Expected outcomes: There will be no differences in demographic parameters (age, gender, side and mechanism of the injury) between groups. Patients in the FG will reach sooner final range of motion (ROM) and muscular strength without limping and will be (subjectively) more satisfied with the treatment. There will be no statistically significant differences observed between groups according to the number of complications and in the end functional results with return to pre-injury activities.

Conditions

  • Achilles Tendon Rupture
  • Percutaneous Repair
  • Local Anesthesia
  • Postoperative Complications

Interventions

PROCEDURE

Percutaneous suturing

Sponsors & Collaborators

  • University Medical Centre Maribor

    lead OTHER

Principal Investigators

  • Andrej Cretnik, MD, PhD · University Medical Center Maribor, Ljubljanska 5, 2000 Maribor, Slovenia

  • Roman Košir, MD, PhD · University Medical Center Maribor, Ljubljanska 5, 2000 Maribor, Slovenia

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-01-01
Primary Completion
2004-12-31
Completion
2007-12-31

Countries

  • Slovenia

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04692883 on ClinicalTrials.gov