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)

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.

Study Overview

• Status: Completed
• Conditions: Anterior Cruciate Ligament Rupture
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 141

Contacts and Locations

Study Locations

• France
  • Rennes, France, 35000
    • Rennes University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Athletic patients who have consulted in Sports Medicine Department at Rennes University Hospital

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Rennes University Hospital
• Investigators: Principal Investigator: Jacqueline JAN, MD, Rennes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2017
• Primary Completion (Actual): August 31, 2018
• Study Completion (Actual): August 31, 2018

Study Registration Dates

• First Submitted: September 5, 2018
• First Submitted That Met QC Criteria: September 10, 2018
• First Posted (Actual): September 12, 2018

Study Record Updates

• Last Update Posted (Actual): September 12, 2018
• Last Update Submitted That Met QC Criteria: September 10, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: Anterior cruciate ligament; ligamentoplasty; isokinetics
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Knee Injuries; Rupture; Anterior Cruciate Ligament Injuries
• Other Study ID Numbers: 35RC17_3074

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No