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Clinical Trials/NCT03308760
NCT03308760CompletedNot Applicable

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

Centre Hospitalier Universitaire Dijon1 site in 1 country20 target enrollmentStarted: December 2012Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
20
Locations
1
Primary Endpoint
Postural parameters measured using a stabilometry platform

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 45 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Postural parameters measured using a stabilometry platform

Time Frame: 6 months

measured using a stabilometry platform

Muscle strength

Time Frame: 6 months

measured on the healthy and injured side using an isokinetic dynamometer

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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