Can Sensorimotor Function Predict Graft Rupture After ACL Reconstruction

Recruiting

• Conditions: Anterior Cruciate Ligament Injuries
• Interventions: Other: Different measures of muscle function such as muscle strength, hop tests, postural orientation and muscle activation

• Registration Number: NCT04162613
• Lead Sponsor: Umeå University

Brief Summary

In this longitudinal prospective cohort study including young people with anterior cruciate ligament (ACL) reconstruction, the investigators will evaluate if poor sensorimotor function at baseline can predict 1) graft rupture 2) the risk of contra-lateral ACL injury and 3) failure to return to sport/previous activity level within 3 years following ACL reconstruction.

Detailed Description

In this longitudinal prospective cohort study including young athletic men and women (aged 15-35) with ACL reconstruction (ACLR), it will be investigated if poor sensorimotor function at baseline (1 year post ACLR), such as hop performance, muscle strength and postural orientation can predict 1) graft rupture 2) the risk of contra-lateral ACL injury and 3) failure to return to sport/previous activity level within 3 years following ACLR.

Statistics Separate logistic regression models will be used to elucidate the influence of each muscle sensorimotor function variable on the outcomes (graft rupture, contra-lateral injury, return to sport/activity level failure), adjusted for potential confounders. With the LSI for the single-leg hop test as main outcome, power calculations show that with a re-injury rate of 7%, an estimated odds ratio of 0.95, power=80% and alpha=5 %, at least 174 individuals are needed. Based on this calculation, 200 individuals will be included for the prospective analysis, allowing for an approximate drop-out of 10%.

Study Timeline

• Study Start: 2019-10-01
• Study First Submitted: 2019-11-11
• Study First Submitted QC: 2019-11-13
• Study First Posted: 2019-11-14
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-09
• Last Update Posted: 2024-01-10
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• 8-16 months after ACL reconstruction
• With or without associated injuries to other structures of the knee (e.g., collateral ligament(s), meniscal injury)
• Age 15-35 years.

Exclusion Criteria

• ACL injury other knee and previous ACL injury index knee
• Diseases or disorders overriding the knee condition (e.g., neurological or rheumatological disease)
• Not understanding the languages of interest (any Scandinavian language or English).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with ACL reconstruction in Lund and Umeå	Different measures of muscle function such as muscle strength, hop tests, postural orientation and muscle activation	Persons who have suffered a unilateral anterior cruciate ligament injury treated with reconstruction

Primary Outcome Measures

Name	Time	Method
Number of participants with graft rupture	2 years	Number of patients that have sustained a rupture of the reconstructed ligament

Secondary Outcome Measures

Name	Time	Method
Failure to return to sport/previous activity level	2 years	Number of patients that had failed to return to previous sport/activity level
Number of patients with contra-lateral ACL injury	2 years	Number of patients that have sustained an injur to the contra-lateral knee

Trial Locations

Locations (1)

UMotion laboratory; 🇸🇪 Umeå, Sweden