Clinical trial NCT04162613: Can Sensorimotor Function Predict Graft Rupture After ACL Reconstruction
Official title: Sensorimotor Function as Predictor for Graft Rupture After Anterior Cruciate Ligament Reconstruction: A Prospective Cohort Study (STOP Graft Rupture)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Anterior Cruciate Ligament Injuries
Keywords: anterior cruciate ligament injury
re-injury
muscle function
functional performance
rehabilitation
physiotherapy
sensorimotor control
Lead sponsor: Umeå University
Sponsor class: OTHER
Collaborators: name: Lund University
First posted: 2019-11-14
Enrollment: 200
Sex: ALL
Minimum age (years): 15
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be recruited from the Department of Orthopedics, Norrland University hospital, Umeå, Sweden and Skåne University Hospital, Lund, Sweden.

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%.

Eligibility criteria: 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).

Primary outcomes:
measure: Number of participants with graft rupture
timeFrame: 2 years
Secondary outcomes:
measure: Number of patients with contra-lateral ACL injury
timeFrame: 2 years
measure: Failure to return to sport/previous activity level
timeFrame: 2 years
Other outcomes:
Locations:
city: Umeå
country: Sweden
facility: UMotion laboratory
Study officials:
affiliation: Umeå University
name: Anna Cronström, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Umeå University
name: Charlotte Häger, Professor
role: STUDY_CHAIR
References:
citation: Cronstrom A, Ageberg E, Hager CK. Does sensorimotor function predict graft rupture, contra-lateral injury or failure to return to sports after ACL reconstruction? A protocol for the STOP Graft Rupture study. BMJ Open. 2021 Jan 8;11(1):e042031. doi: 10.1136/bmjopen-2020-042031.