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

NCT03308760 | Completed

• 1 other identifier: GREMEAUX 2013
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Unilateral Rupture of the Achilles Tendon

Outcome Measures

Primary Outcomes (2)

• Muscle strength

  measured on the healthy and injured side using an isokinetic dynamometer

  6 months

• Postural parameters measured using a stabilometry platform

  measured using a stabilometry platform

  6 months

Interventions

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

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients followed at the Convalescence and Rehabilitation Unit of Dijon CHU

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

CHU Dijon Bourgogne

Dijon, 21000, France

Location

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2017
• First Posted: October 13, 2017
• Study Start: December 1, 2012
• Primary Completion: August 1, 2014
• Study Completion: December 1, 2014
• Last Updated: October 13, 2017

Record last verified: 2017-10

Locations

FR (1)