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

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ClinicalTrials.gov Identifier: NCT03308760
Recruitment Status : Completed
First Posted : October 13, 2017
Last Update Posted : October 13, 2017
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon

Brief Summary:
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.

Condition or disease Intervention/treatment
Acute Unilateral Rupture of the Achilles Tendon Other: Questionnaire Other: Static stabilometry Other: Isokinetic test

Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Analytical and Functional Evaluation of Recovery Following Acute Rupture of the Achilles Tendon and Surgical Repair in Young Patients
Actual Study Start Date : December 2012
Actual Primary Completion Date : August 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears
U.S. FDA Resources


Intervention Details:
    Other: Questionnaire
    Interview concerning the post-operative rehabilitation programme and a functional analysis using the American Orthopaedic Foot and Ankle Society questionnaire
    Other: Static stabilometry
    on a force plate, in a double- then single-foot stance, with the eyes open and then closed
    Other: Isokinetic test
    Isokinetic test of the flexors/extensors and invertors/evertors of the ankle


Primary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients followed at the Convalescence and Rehabilitation Unit of Dijon CHU
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03308760


Locations
France
CHU Dijon Bourgogne
Dijon, France, 21000
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon

Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT03308760     History of Changes
Other Study ID Numbers: GREMEAUX 2013
First Posted: October 13, 2017    Key Record Dates
Last Update Posted: October 13, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Rupture
Wounds and Injuries