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Can Sensorimotor Function Predict Graft Rupture After ACL Reconstruction

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04162613
Enrollment
201
Registered
2019-11-14
Start date
2019-10-01
Completion date
2026-02-15
Last updated
2026-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anterior Cruciate Ligament Injuries

Keywords

anterior cruciate ligament injury, re-injury, muscle function, functional performance, rehabilitation, physiotherapy, sensorimotor control

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%.

Interventions

OTHERDifferent 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.

Sponsors

Umeå University
Lead SponsorOTHER
Lund University
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
15 Years to 35 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Number of participants with graft rupture2 yearsNumber of patients that have sustained a rupture of the reconstructed ligament

Secondary

MeasureTime frameDescription
Number of patients with contra-lateral ACL injury2 yearsNumber of patients that have sustained an injur to the contra-lateral knee
Failure to return to sport/previous activity level2 yearsNumber of patients that had failed to return to previous sport/activity level

Countries

Sweden

Contacts

PRINCIPAL_INVESTIGATORAnna Cronström, PhD

Umeå University

STUDY_CHAIRCharlotte Häger, Professor

Umeå University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 30, 2026