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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05712109
Other study ID # FoVeA
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 15, 2017
Est. completion date February 5, 2023

Study information

Verified date March 2023
Source University Hospital, Caen
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 103
Est. completion date February 5, 2023
Est. primary completion date January 15, 2020
Accepts healthy volunteers No
Gender All
Age group 16 Years to 55 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Follow-up after Anterior cruciate ligament reconstruction
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

Locations

Country Name City State
France CHU Caen Normandie Caen

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 Individual characteristics Personal characteristics recorded in the medical report as age, gender, type of sport and sport level of practice and return to sport after the surgery 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 Injury characteristics Injury characteristics recorded in the medical report as the type of injury (ACL only, ACL and meniscus, ACL with other ligament injury, recurrent ACL injury) the time before surgery, the type of rehabilitation before and after surgery 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 Surgery characteristics Surgery characteristics recorded in the medical report as the type of surgery, the surgery duration and tourniquet time 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
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