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CompletedNCT04162613Updated Apr 29, 2026

Can Sensorimotor Function Predict Graft Rupture After ACL Reconstruction

An observational study in Anterior Cruciate Ligament Injuries, sponsored by Umeå University. Completed at 1 site in Sweden. Open to participants aged 15 Years to 35 Years. Per ClinicalTrials.gov, last updated 2026-04-29.

Sponsored by Umeå University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
201
Ages
15 Years to 35 Years
Sex
All
01

Study 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.

Read the 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%.

02

Conditions studied

  • Anterior Cruciate Ligament Injuries

Keywords

  • anterior cruciate ligament injury
  • re-injury
  • muscle function
  • functional performance
  • rehabilitation
  • physiotherapy
  • sensorimotor control
03

In context

Anterior Cruciate Ligament Injuries

512 studies on the registry are indexed under Anterior Cruciate Ligament Injuries; 164 are open to participants now.

This study's enrollment of 201 is above the median of 92 across 127 observational studies indexed under Anterior Cruciate Ligament Injuries.

Browse Anterior Cruciate Ligament Injuries studies →

Lead sponsor

Umeå University is the lead sponsor of 263 studies on the registry; 60 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

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).
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
201 participants (actual)
Patient registry
No

Groups and cohorts

  • Patients with ACL reconstruction in Lund and Umeå

    Persons who have suffered a unilateral anterior cruciate ligament injury treated with reconstruction

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

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.

06

What researchers measure

Primary outcomes

  1. Number of participants with graft rupture

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

    Time frame: 2 years

Secondary outcomes

  1. Number of patients with contra-lateral ACL injury

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

    Time frame: 2 years

  2. Failure to return to sport/previous activity level

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

    Time frame: 2 years

07

Study locations

1 site
  • UMotion laboratory
    Umeå, 90746, Sweden
08

References and documents

Publications

  • 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. PubMed 33419913 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04162613
Lead sponsor
Umeå University
Collaborators
Lund University
Responsible party
Sponsor
First posted
Nov 14, 2019
Start date
Oct 1, 2019
Primary completion
Feb 15, 2026
Completion
Feb 15, 2026
Last update
Apr 29, 2026

Study contacts

Anna Cronström, PhD
principal investigator · Umeå University
Charlotte Häger, Professor
study chair · Umeå University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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