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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date September 2018
Source Rennes University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Description:

The main risk factors for known ACL lesions are female gender, pivotal sports, neuromuscular deficits, proprioceptive, hormonal, morphological deficits ... Moreover, there is also an increase in the number of contralateral fractures in patients who had a ligamentoplasty. There are many articles on the ACL pathology but unequal on the potential risk factors. The only proven risk factor for contralateral rupture is the age of the first episode; the female sex also seems to be important in some studies but remains more controversial. However, many factors have been studied: the intensity of the sport, the sex, the operative technique of ligamentoplasty, the operating duration, the duration of recovery of the sports activity, the level of recovery (of this sporting activity ) ...

Isokinetics is used to measure the peak of strength of quadriceps and hamstrings, in concentric or eccentric, at slow and fast speed and to determine a hamstring / quadriceps ratio to highlight a deficit or imbalance.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms

  • Anterior Cruciate Ligament Injuries
  • Anterior Cruciate Ligament Rupture
  • Rupture

Intervention

Procedure:
Isokinetic evaluation
Isokinetics is used to measure the peak of strength of quadriceps and hamstrings, in concentric or eccentric, at slow and fast speed to determine a hamstring / quadriceps ratio to highlight a deficit or imbalance.

Locations

Country Name City State
France Rennes University Hospital Rennes

Sponsors (1)

Lead Sponsor Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

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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