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

Acute Unilateral Rupture of the Achilles Tendon Clinical Trial

— ACHILLE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03308760
• Other study ID #: GREMEAUX 2013
• Status: Completed
• Phase: N/A
• First received: October 4, 2017
• Last updated: October 9, 2017
• Start date: December 2012
• Est. completion date: December 2014

Study information

• Verified date: October 2017
• Source: Centre Hospitalier Universitaire Dijon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Unilateral Rupture of the Achilles Tendon
• Rupture

Intervention

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

Locations

Country	Name	City	State
France	CHU Dijon Bourgogne	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscle strength	measured on the healthy and injured side using an isokinetic dynamometer	6 months
Primary	Postural parameters measured using a stabilometry platform	measured using a stabilometry platform	6 months