Can Sensorimotor Function Predict Graft Rupture After ACL Reconstruction

Anterior Cruciate Ligament Injuries Clinical Trial

Official title:

Sensorimotor Function as Predictor for Graft Rupture After Anterior Cruciate Ligament Reconstruction: A Prospective Cohort Study (STOP Graft Rupture)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04162613
• Other study ID #: STOP Graft Rupture
• Status: Recruiting
• Start date: October 1, 2019
• Est. completion date: December 2026

Study information

• Verified date: January 2024
• Source: Umeå University
• Contact: Anna Cronström, PhD
• Phone: +46707488770
• Email: anna.cronstrom[@]umu.se
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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%.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 35 Years

Eligibility

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).

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Injuries
• Rupture

Intervention

Other:
• Different measures of muscle function such as muscle strength, hop tests, postural orientation and muscle activation
The participants will be assessed with a physical test battery at baseline including: Isokinetic knee strength, Isometric strength of trunk and lower extremity, Single-leg hop for distance, side hop, postural orientation (single leg-squat, stair descending, forward lunge, Single-leg hop for distance, side-hop), hip and ankle range of joint motion, muscular activation pattern, 3D movement analysis and proprioception test. At follow-up (2 years), the participants will be asked to answer a survey about new ACL injuries and return to sport/previous activity level.

Locations

Country	Name	City	State
Sweden	UMotion laboratory	Umeå

Sponsors (2)

Lead Sponsor	Collaborator
Umeå University	Lund University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with graft rupture	Number of patients that have sustained a rupture of the reconstructed ligament	2 years
Secondary	Number of patients with contra-lateral ACL injury	Number of patients that have sustained an injur to the contra-lateral knee	2 years
Secondary	Failure to return to sport/previous activity level	Number of patients that had failed to return to previous sport/activity level	2 years