Skip to main content
OpenTrials
Completed

NCT Number: NCT05897970

Association Between 4-Month Isokinetic Testing Measures and Second Knee Injuries After Primary Anterior Cruciate Ligament Reconstruction

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

ACL Injury Anterior Cruciate Ligament Injuries Knee Injuries Leg Injuries Muscle Weakness Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Wounds and Injuries

Age range

16 year–55 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Caen Normandie

Caen, 14000, France

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Exclusion criteria

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

Treatment and study plan

Return-to-sport (RTS) follow-up

Diagnostic Test

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

Primary outcomes

  1. Change in Strength

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

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

Secondary outcomes

  1. Individual characteristics

    Time frame: 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;

    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 and severe reinjury on the operated knee or contralateral knee.

  2. Surgery characteristics

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

    Surgery characteristics recorded in the medical report as the type of surgery, the surgery duration

  3. Re-injuries

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

    Web based questionnaire about any sever knee injury (meniscus or ACL) after the primary ACLR

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

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

    Web based questionnaire with completion of the Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI) scale.

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Registry information

Official study title

Association Between 4-Month Isokinetic Testing Measures and Second Knee Injuries After

Acronym: PREDICT-ACLv2

Important dates

Study start
2021
Primary completion
2021
Study completion
2023
First posted
Jun 12, 2023
Registry last updated
Mar 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.