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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 ? (DIS-RRACT)

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ClinicalTrials.gov Identifier: NCT03668210
Recruitment Status : Completed
First Posted : September 12, 2018
Last Update Posted : September 12, 2018
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital

Brief 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.


Condition or disease Intervention/treatment
Anterior Cruciate Ligament Rupture Procedure: Isokinetic evaluation

Detailed 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.

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Study Type : Observational
Actual Enrollment : 141 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official 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 ?
Actual Study Start Date : July 31, 2017
Actual Primary Completion Date : August 31, 2018
Actual Study Completion Date : August 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

Group/Cohort Intervention/treatment
Patients with contralateral ACL after Ligamentoplasty

Athletic patients who have consulted in Sports Medicine Department at the Rennes University Hospital, victims of an ACL rupture during sports activity and who declared a contralateral ACL after the ligamentoplasty.

Isokinetic evaluation.

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.

Patients without contralateral ACL rupture

Athletic patients who have consulted in Sports Medicine Department at Rennes University Hospital, without ACL rupture.

Isokinetic evaluation.

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.




Primary Outcome Measures :
  1. Evaluation of relative hamstrings deficiency versus quadriceps expressed by a concentric hamstrings/quadriceps ratio [ Time Frame: At inclusion ]
    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.


Secondary Outcome Measures :
  1. 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. [ Time Frame: At inclusion ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Athletic patients who have consulted in Sports Medicine Department at Rennes University Hospital
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03668210


Locations
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France
Rennes University Hospital
Rennes, France, 35000
Sponsors and Collaborators
Rennes University Hospital
Investigators
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Principal Investigator: Jacqueline JAN, MD Rennes University Hospital
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Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT03668210    
Other Study ID Numbers: 35RC17_3074
First Posted: September 12, 2018    Key Record Dates
Last Update Posted: September 12, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rennes University Hospital:
Anterior cruciate ligament
ligamentoplasty
isokinetics
Additional relevant MeSH terms:
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Rupture
Anterior Cruciate Ligament Injuries
Wounds and Injuries
Knee Injuries
Leg Injuries