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CompletedNCT03668210DIS-RRACTUpdated Sep 12, 2018

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 ?

An observational study in Anterior Cruciate Ligament Rupture, sponsored by Rennes University Hospital. Completed at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-09-12.

Sponsored by Rennes University Hospital · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
141
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Anterior Cruciate Ligament Rupture

Keywords

  • Anterior cruciate ligament
  • ligamentoplasty
  • isokinetics
03

In context

Rupture

557 studies on the registry are indexed under Rupture; 97 are open to participants now.

This study's enrollment of 141 is above the median of 100 across 203 observational studies indexed under Rupture.

Browse Rupture studies →

Lead sponsor

Rennes University Hospital is the lead sponsor of 440 studies on the registry; 51 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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

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
05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
141 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • 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

Interventions

  • ProcedureIsokinetic 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: At inclusion

Secondary outcomes

  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.

    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.

    Time frame: At inclusion

07

Study locations

1 site
  • Rennes University Hospital
    Rennes, 35000, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 12, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03668210
Lead sponsor
Rennes University Hospital
Responsible party
Sponsor
First posted
Sep 12, 2018
Start date
Jul 31, 2017
Primary completion
Aug 31, 2018
Completion
Aug 31, 2018
Last update
Sep 12, 2018

Study contacts

Jacqueline JAN, MD
principal investigator · Rennes University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.

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