Anterior Cruciate Ligament InjuriesNCT04162613
Can Sensorimotor Function Predict Graft Rupture After ACL Reconstruction
An observational study of Anterior Cruciate Ligament Injuries, run by Umeå University at 1 site in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 15 to 35 years
- Conditions the study is for
- Anterior Cruciate Ligament Injuries
- What is being tested?
- Different measures of muscle function such as muscle strength, hop tests, postural orientation and muscle activation
- How many people
- 201 participants
- Where
- 1 siteSweden
- Study dates
- 1 Oct 2019to 15 Feb 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients will be recruited from the Department of Orthopedics, Norrland University hospital, Umeå, Sweden and Skåne University Hospital, Lund, Sweden.
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sensorimotor Function as Predictor for Graft Rupture After Anterior Cruciate Ligament Reconstruction: A Prospective Cohort Study (STOP Graft Rupture)
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%.
- Conditions
- Anterior Cruciate Ligament Injuries
- Being tested
- Different measures of muscle function such as muscle strength, hop tests, postural orientation and muscle activation
- Keywords
- anterior cruciate ligament injury, re-injury, muscle function, functional performance, rehabilitation, physiotherapy, sensorimotor control
- Medical subject headings
- Anterior Cruciate Ligament Injuries, Reinjuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Different measures of muscle function such as muscle strength, hop tests, postural orientation and muscle activationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with ACL reconstruction in Lund and Umeå | Persons who have suffered a unilateral anterior cruciate ligament injury treated with reconstruction Receives: Other: Different measures of muscle function such as muscle strength, hop tests, postural orientation and muscle activation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with graft rupture
Number of patients that have sustained a rupture of the reconstructed ligament
Measured: 2 years
Secondary outcomes (2)
Number of patients with contra-lateral ACL injury
Number of patients that have sustained an injur to the contra-lateral knee
Measured: 2 years
Failure to return to sport/previous activity level
Number of patients that had failed to return to previous sport/activity level
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2019
- Study start1 Oct 2019
- Primary completion15 Feb 2026
- Study completion15 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anterior Cruciate Ligament InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Collaborators
- Lund University
- Responsible party
- Sponsor
- Investigators
- Anna Cronström, PhD, Principal investigator, Umeå UniversityCharlotte Häger, Professor, Study chair, Umeå University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04162613
- Sponsor's protocol ID
- STOP Graft Rupture
- Status last verified
- Apr 2026
- First submitted
- 11 Nov 2019
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensorimotor Function as Predictor for Graft Rupture After Anterior Cruciate Ligament Reconstruction: A Prospective Cohort Study (STOP Graft Rupture)
- ClinicalTrials.gov ID
- NCT04162613
- Acronym / sponsor ID
- STOP Graft Rupture
- Conditions
- Anterior Cruciate Ligament Injuries
- Keywords
- anterior cruciate ligament injury, re-injury, muscle function, functional performance, rehabilitation, physiotherapy, sensorimotor control
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Collaborators
- Lund University
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 15 Feb 2026 (actual)
- Study completion
- 15 Feb 2026 (actual)
- First posted
- 14 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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%.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with ACL reconstruction in Lund and Umeå | – | Other: Different measures of muscle function such as muscle strength, hop tests, postural orientation and muscle activationPersons who have suffered a unilateral anterior cruciate ligament injury treated with reconstruction |
Who may qualify
- Ages
- 15 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients will be recruited from the Department of Orthopedics, Norrland University hospital, Umeå, Sweden and Skåne University Hospital, Lund, Sweden.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Different measures of muscle function such as muscle strength, hop tests, postural orientation and muscle activationThe 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. | Other | Patients with ACL reconstruction in Lund and Umeå |
Primary outcome
Number of participants with graft rupture
Time frame: 2 years
Number of patients that have sustained a rupture of the reconstructed ligament
2 secondary outcomes
Number of patients with contra-lateral ACL injury
Time frame: 2 years
Failure to return to sport/previous activity level
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Derived from this study: PubMed 33419913Cronstrom 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna Cronström, PhD principal investigator
Umeå University
Charlotte Häger, Professor study chair
Umeå University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anterior Cruciate Ligament Injuries, run by Umeå University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with graft rupture (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04162613, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.