NCT05712109

Brief Summary

Anterior cruciate ligament (ACL) tear is a frequent and devastating injury in sport, especially in pivoting-contact disciplines. In many cases, athletes will undergo an ACL reconstruction (ACL-R) for recovering knee stability, preventing further injuries and returning to sport (RTS). Among the criteria for RTS, knee muscle strength is the most used objective criteria and especially the symmetry of knee flexors and/or extensors between the operated and uninjured knee. Isokinetic testing of knee muscle strength is considered as a reference for knee muscle testing during the follow up stages after ACL-R. This evaluation allows to measure the strength (torque) of knee flexors and extensors at several angular velocities. However, there is no relevant litterature about the force-velocity (Fo-v) relationship of knee flexors and extensors after ACL-R. The present study aimed to evaluate and test the differences between the Fo-v relationship parameters between the operated and uninjured knees at 4 months and 8 months after ACL-R, using the 2-points method with isokinetic testing. Also, the investigators aimed to test the impact of the type of surgery (patellar tendon autograft vs. hamstring tendon autograft) on the Fo-v relationship after ACL-R

Trial Health

87
On Track

Trial Health Score

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

Enrollment
103

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2017

Longer than P75 for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2017

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2020

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

January 26, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 3, 2023

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 5, 2023

Completed
Last Updated

March 26, 2025

Status Verified

March 1, 2023

Enrollment Period

3 years

First QC Date

January 26, 2023

Last Update Submit

March 24, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Change in strength

    Measurement of knee extensors and flexors peak strength (in newton.meter, Nm) on isokinetic dynamometer at two angular velocities of 60°/s and 240°/s respectively

    Time Frame: ACL group: Two evaluations on both injured and healthy knees: (1) 4 months after surgery and (2) 8 months after surgery; Routine practice following guidelines

  • Change in the force-velocity relationship

    Calculation of the corresponding slope and maximal force (Y-intercept) of the regression line of the force-velocity curve

    Time Frame: ACL group: Two evaluations on both injured and healthy knees: (1) 4 months after surgery and (2) 8 months after surgery; Routine practice following guidelines

Secondary Outcomes (3)

  • Individual characteristics

    Time Frame: ACL group: Two evaluations on both injured and healthy knees: (1) 4 months after surgery and (2) 8 months after surgery; Routine practice following guidelines

  • Injury characteristics

    Time Frame: ACL group: Two evaluations on both injured and healthy knees: (1) 4 months after surgery and (2) 8 months after surgery; Routine practice following guidelines

  • Surgery characteristics

    Time Frame: ACL group: Two evaluations on both injured and healthy knees: (1) 4 months after surgery and (2) 8 months after surgery; Routine practice following guidelines

Study Arms (1)

ACL group

The patients were referred to the sport medicine department for the post ACL-R follow-up including isokinetic knee muscle strength evaluations at 4 months and 8 months after the surgery

Other: Follow-up after Anterior cruciate ligament reconstruction

Interventions

The patients were referred to the sport medicine department for the post ACL-R follow-up including isokinetic knee muscle strength evaluations at 4 months and 8.months after the surgery

ACL group

Eligibility Criteria

Age16 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

All sports patients included in the sport medicine follow-up protocole with isokinetic muscular assessment at 4 months and 8 months after ACL reconstruction surgery since January 2017

You may qualify if:

  • Patients who have had an ACL reconstruction surgery (isolated or associated with other meniscal or ligamentary surgery)
  • Patient included in the sport medicine follow-up protocole with intermediate and final isokinetic muscular assessment at 4 months and8 months after surgery respectively
  • Patients who completed both tests at the 60°/s and 240°/s velocities

You may not qualify if:

  • Patient who did not participate in all follow-up consultations and isokinetic muscular assessments
  • Cognitive or sensory impairment making it impossible to understand the information form
  • Neurological, traumatic or osteoarticular history responsible for muscle imbalance prior to surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Caen Normandie

Caen, 14000, France

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament InjuriesMuscle Weakness

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and InjuriesMuscular DiseasesMusculoskeletal DiseasesNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2023

First Posted

February 3, 2023

Study Start

January 15, 2017

Primary Completion

January 15, 2020

Study Completion

February 5, 2023

Last Updated

March 26, 2025

Record last verified: 2023-03

Locations