NCT05897970

Brief Summary

Anterior cruciate ligament (ACL) is a frequent and disabling injury in athletes. Most of the time, ACL reconstruction (ACLR) is consider for regaining function and returning to preinjury sports while reducing the risk of secondary injuries. However, the risk of secondary severe knee injury is increased after ACLR, especially in athletes returning to strenuous activities. If strength symmetry is considered as an important factor in the Return-to-sport (RTS) decision, there is conflicting data about the association between strength symmetry and the risk of second knee injury after ACLR. The main objective of this study was to test if knee muscles strength symmetry at 4 months was associated with the psychological readiness and incidence of subsequent severe injury of both knees at a minimum 2 years follow-up after ACL-R.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2021

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

May 1, 2021

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 1, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 12, 2023

Completed
Last Updated

March 26, 2025

Status Verified

June 1, 2023

Enrollment Period

Same day

First QC Date

June 1, 2023

Last Update Submit

March 24, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in Strength

    Measurement of knee extensors and flexors peak strength (in newton.meter, Nm) on isokinetic dynamometer.

    ACL group: Two evaluations on both injured and healthy knees: 3-4 months after surgery; Routine practice following guidelines]

Secondary Outcomes (4)

  • Individual characteristics

    ACLR group: Two follow-up medical consultations: (1) 4 months after surgery and (2) 2 years after the surgery for return to sport and reinjury;

  • Surgery characteristics

    ACLR group: Two follow-up medical consultations 4 months after surgery

  • Re-injuries

    ACLR group: One evaluation with a minimum 2 years follow-up after the surgery

  • Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI) scale.

    ACLR group: One evaluation with a minimum 2 years follow-up after the surgery

Study Arms (1)

ACLR patients with Return-to-sport (RTS) follow-up

All sports patients who had a muscle evaluation at 3-4 months after ACLR since January 2017

Diagnostic Test: Return-to-sport (RTS) follow-up

Interventions

All sports patients who had a muscle evaluation at 3-4 months after ACLR since January 2017

ACLR patients with Return-to-sport (RTS) follow-up

Eligibility Criteria

Age16 Years - 55 Years
Sexall
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 3-4 months after ACL reconstruction surgery since January 2017 with a minium 2 years follow-up in the sports medicine department, Return To Sport Process

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 3-4 months Patient who received the information form Patients with access to the Internet

You may not qualify if:

  • Patient who did not participate in all follow-up consultations and isokinetic muscular assessments Patients who had a previous knee surgery before the ACLR 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 InjuriesKnee InjuriesMuscle Weakness

Condition Hierarchy (Ancestors)

Leg 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
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2023

First Posted

June 12, 2023

Study Start

May 1, 2021

Primary Completion

May 1, 2021

Study Completion

May 1, 2023

Last Updated

March 26, 2025

Record last verified: 2023-06

Locations