Association Between 4-Month Isokinetic Testing Measures and Second Knee Injuries After Primary Anterior Cruciate Ligament Reconstruction (PREDICT-ACLv2)

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

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.

Study Overview

• Status: Completed
• Conditions: Muscle Weakness; Knee Injuries; ACL Injury
• Intervention / Treatment: Diagnostic test: Return-to-sport (RTS) follow-up

• Study Type: Observational
• Enrollment (Actual): 150

Contacts and Locations

Study Locations

• France
  • Caen, France, 14000
    • CHU Caen Normandie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; All sports patients who had a muscle evaluation at 3-4 months after ACLR since January 2017

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 and severe reinjury on the operated knee or contralateral knee.	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	Surgery characteristics recorded in the medical report as the type of surgery, the surgery duration	ACLR group: Two follow-up medical consultations 4 months after surgery
Re-injuries	Web based questionnaire about any sever knee injury (meniscus or ACL) after the primary ACLR	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.	Web based questionnaire with completion of the 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

Collaborators and Investigators

• Sponsor: University Hospital, Caen

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Actual): May 1, 2021
• Study Completion (Actual): May 1, 2023

Study Registration Dates

• First Submitted: June 1, 2023
• First Submitted That Met QC Criteria: June 1, 2023
• First Posted (Actual): June 12, 2023

Study Record Updates

• Last Update Posted (Actual): June 12, 2023
• Last Update Submitted That Met QC Criteria: June 1, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Leg Injuries; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Weakness; Wounds and Injuries; Anterior Cruciate Ligament Injuries; Knee Injuries
• Other Study ID Numbers: PREDICT-ACLv2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No