NCT04162613

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
201

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 11, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 14, 2019

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2026

Completed
Last Updated

April 29, 2026

Status Verified

April 1, 2026

Enrollment Period

6.4 years

First QC Date

November 11, 2019

Last Update Submit

April 28, 2026

Conditions

Keywords

anterior cruciate ligament injuryre-injurymuscle functionfunctional performancerehabilitationphysiotherapysensorimotor control

Outcome Measures

Primary Outcomes (1)

  • Number of participants with graft rupture

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

    2 years

Secondary Outcomes (2)

  • Number of patients with contra-lateral ACL injury

    2 years

  • Failure to return to sport/previous activity level

    2 years

Study Arms (1)

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

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.

Patients with ACL reconstruction in Lund and Umeå

Eligibility Criteria

Age15 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients will be recruited from the Department of Orthopedics, Norrland University hospital, Umeå, Sweden and Skåne University Hospital, Lund, Sweden.

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UMotion laboratory

Umeå, 90746, Sweden

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Anterior Cruciate Ligament InjuriesReinjuries

Interventions

Muscle Strength

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

Physical ExaminationDiagnostic Techniques and ProceduresDiagnosisMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Anna Cronström, PhD

    Umeå University

    PRINCIPAL INVESTIGATOR
  • Charlotte Häger, Professor

    Umeå University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 11, 2019

First Posted

November 14, 2019

Study Start

October 1, 2019

Primary Completion

February 15, 2026

Study Completion

February 15, 2026

Last Updated

April 29, 2026

Record last verified: 2026-04

Locations