Skip to main content
OpenTrials
Completed

NCT Number: NCT04162613

Can Sensorimotor Function Predict Graft Rupture After ACL Reconstruction

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Anterior Cruciate Ligament Injuries Knee Injuries Leg Injuries Reinjuries Wounds and Injuries

Age range

15 year–35 year

Sex eligibility

All sexes

Study type

Observational

Primary location

UMotion laboratory

Umeå, 90746, Sweden

About this study

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%.

Who can participate

Healthy volunteers accepted: No

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

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).

Treatment and study plan

Different measures of muscle function such as muscle strength, hop tests, postural orientation and muscle activation

Other

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.

Primary outcomes

  1. Number of participants with graft rupture

    Time frame: 2 years

    Number of patients that have sustained a rupture of the reconstructed ligament

Secondary outcomes

  1. Number of patients with contra-lateral ACL injury

    Time frame: 2 years

    Number of patients that have sustained an injur to the contra-lateral knee

  2. Failure to return to sport/previous activity level

    Time frame: 2 years

    Number of patients that had failed to return to previous sport/activity level

Sponsors and collaborators

Lead sponsor

Umeå University

Other

Collaborators

  • Lund University

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Nov 14, 2019
Registry last updated
Apr 29, 2026

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.