Anterior Cruciate Ligament Rupture Clinical Trial
— DIS-RRACTOfficial title:
Risk Factor of Anterior Cruciate Ligament Rupture After Ligamentoplasty : What is the Importance of a Relative Deficit of Contralateral Hamstrings Assessed by Isokinetic in Postoperative ?
NCT number | NCT03668210 |
Other study ID # | 35RC17_3074 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | July 31, 2017 |
Est. completion date | August 31, 2018 |
Verified date | September 2018 |
Source | Rennes University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Anterior cruciate ligament (ACL) is a common pathology (37 000 operations in 2006, nearly 43
000 in 2012 in France) justifying more and more operating indications in younger and younger
patients. 70-80% of ACL ruptures occur without contact, which makes it a major public health
interest because of its frequency and accessibility in terms of prevention.
The place of isokinetic assessment is important pre and postoperatively so that it has become
systematic.
Status | Completed |
Enrollment | 141 |
Est. completion date | August 31, 2018 |
Est. primary completion date | August 31, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Athletic patients all levels - victims of ACL rupture during sports practice, - operated by the same surgeon - having been evaluated in isokinetic postoperative in the Sports Medicine Department of Rennes University Hospital - having resumed a sporting activity - with the first ACL rupture between 01/01/1994 and 12/31/2015 Exclusion Criteria: - Patients with ACL rupture outside of a sporting context - not having resumed post-operative sports activity on the maximum follow-up period of 15 years - not evaluated for isokinetic activity in the sports medicine department - minors at the time of inclusion |
Country | Name | City | State |
---|---|---|---|
France | Rennes University Hospital | Rennes |
Lead Sponsor | Collaborator |
---|---|
Rennes University Hospital |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluation of relative hamstrings deficiency versus quadriceps expressed by a concentric hamstrings/quadriceps ratio | Isokineticism makes it possible to measure the peak of force of quadriceps and hamstrings. Concentric hamstrings/quadriceps ratio in isokinetic is calculated to detect a relative deficiency if it is below threshold values of 55% at 60 °/s slow speed, or 65% at 180 °/s fast speed. | At inclusion | |
Secondary | Investigating whether a lack of recruitment of hamstring at fast speed is a potential risk factor for ACL rupture, by evaluating hamstrings/quadriceps ratio in isokinetics. | The lack of recruitment of the hamstrings when increasing speed is defined as normal ratios of peaks of force at the two speeds in isokinetic, but with an increase of the ratio hamstrings/Quadriceps in concentric at fast speed lower than 10%, with reference to the value of the ratio hamstrings/Quadriceps at slow speed. | At inclusion |
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