NCT03668210

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
141

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 31, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2018

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

September 5, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 12, 2018

Completed
Last Updated

September 12, 2018

Status Verified

September 1, 2018

Enrollment Period

1.1 years

First QC Date

September 5, 2018

Last Update Submit

September 10, 2018

Conditions

Keywords

Anterior cruciate ligamentligamentoplastyisokinetics

Outcome Measures

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.

    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.

    At inclusion

Study Arms (2)

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

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 with contralateral ACL after LigamentoplastyPatients without contralateral ACL rupture

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rennes University Hospital

Rennes, 35000, France

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Study Officials

  • Jacqueline JAN, MD

    Rennes University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2018

First Posted

September 12, 2018

Study Start

July 31, 2017

Primary Completion

August 31, 2018

Study Completion

August 31, 2018

Last Updated

September 12, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations