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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

October 4, 2017
October 13, 2017
October 13, 2017
December 2012
August 2014   (Final data collection date for primary outcome measure)
  • Muscle strength [ Time Frame: 6 months ]
    measured on the healthy and injured side using an isokinetic dynamometer
  • Postural parameters measured using a stabilometry platform [ Time Frame: 6 months ]
    measured using a stabilometry platform
Same as current
No Changes Posted
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Analytical and Functional Evaluation of Recovery Following Acute Rupture of the Achilles Tendon and Surgical Repair in Young Patients
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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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
Patients followed at the Convalescence and Rehabilitation Unit of Dijon CHU
Acute Unilateral Rupture of the Achilles Tendon
  • 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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
Same as current
December 2014
August 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 45 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT03308760
GREMEAUX 2013
Not Provided
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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Centre Hospitalier Universitaire Dijon
Centre Hospitalier Universitaire Dijon
Not Provided
Not Provided
Centre Hospitalier Universitaire Dijon
October 2017