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Completed

NCT Number: NCT03308760

Analytical and Functional Evaluation of Recovery Following Acute Rupture of the Achilles Tendon and Surgical Repair in Young Patients

Acute rupture of the Achilles tendon is a very frequent sports injury. Surgical repair is the usual treatment in young subjects, and although the optimal technique is still a matter of debate, conventional surgery with a direct approach is still the reference technique in young sportsmen and women. Studies investigating the evolution of ankle muscle strength following surgery for a ruptured Achilles tendon are rare, even though it is a crucial criterion to determine the possibility of returning to the sport. This project thus proposes to study, in comparison with the healthy ankle:(1) the evolution of muscle strength in the flexors/extensors and invertors/evertors of the injured ankle, evaluated using an isokinetic dynamometer, and (2) the evolution of stabilometry parameters, at 6 months, then at 12 months, following surgery for acute unilateral rupture of the Achilles tendon, operated on using the conventional technique in young sportsmen and women and in comparison with the healthy side.

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Key information

Conditions

Acute Unilateral Rupture of the Achilles Tendon

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Dijon Bourgogne

Dijon, 21000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • persons informed about the research
  • sportsmen and women (competition or leisure, practiced > 3h/week)
  • Between 18 and 45 years old
  • First episode of acute traumatic unilateral rupture of the Achilles tendon
  • Open surgery in the Orthopaedic and Traumatology Department of Dijon University Hospital
  • Identical post-operative immobilisation programme for 6 weeks
  • Absence of major post-operative complications delaying the rehabilitation

Exclusion criteria

  • persons without national health insurance cover
  • concomitant joint disease that could be aggravated by the tests
  • heart disease/contra-indication to effort required during the isokinetic test
  • management other than open surgery (orthopaedic, functional, percutaneous surgery, …)
  • Rupture of the contralateral tendon
  • Contra-indication for the use of the Biodex S4 pro

Treatment and study plan

Questionnaire

Other

Interview concerning the post-operative rehabilitation programme and a functional analysis using the American Orthopaedic Foot and Ankle Society questionnaire

Static stabilometry

Other

on a force plate, in a double- then single-foot stance, with the eyes open and then closed

isokinetic test

Other

Isokinetic test of the flexors/extensors and invertors/evertors of the ankle

Primary outcomes

  1. Muscle strength

    Time frame: 6 months

    measured on the healthy and injured side using an isokinetic dynamometer

  2. Postural parameters measured using a stabilometry platform

    Time frame: 6 months

    measured using a stabilometry platform

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Acronym: ACHILLE

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Oct 13, 2017
Registry last updated
Oct 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.