Rate of Non-copers to Non-surgical ACL Treatment After 3 Months of Rehabilitation
June 30, 2026 updated by: Vejle Hospital
Rate of Non-copers to Non-surgical ACL Treatment After 3 Months of Rehabilitation - a Prospective Cohort Study
The aim is to determine the sensitivity and specificity of a screening tool to identify patients who undergo ACL reconstruction (non-copers) after 3 months of standard rehabilitation following an anterior Cruciate ligament (ACL) injury.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
All included patients are referred to municipal rehabilitation to resolve effusion and range of motion deficits before the first screening (baseline screening) is completed.
Hereafter the patients follow 3 months municipal rehabilitation before the second screening (3 months screening).
A physiotherapist performs the screening and at the second screening, this is performed prior to consulting an orthopaedic surgeon.
Study Type
Observational
Enrollment (Estimated)
357
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Region Syddanmark
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Vejle, Region Syddanmark, Denmark, 7100
- Vejle Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 49 years (Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients will be recruited from the outpatient clinic at the Department of Orthopaedic Surgery at Vejle Hospital, Denmark
Description
Inclusion Criteria:
- unilateral primary ACL injury
- Index injury no older than 6 months
Exclusion Criteria:
- Multiligament rupture
- Large cartillage or meniscus injuries
- Scheduled ACL reconstruction within 3 months
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of patients undergoing ACL reconstruction after 3 months of standard rehabilitation
Time Frame: 3 months
|
Patients undergoing ACL reconstruction after 3 months of standard rehabilitation are defined as non-copers to the non-surgical treatment, which will define the sensitivity and specificity of the screening examination.
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Claus Varnum, ph.d., Vejle Hosptal
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 19, 2021
Primary Completion (Estimated)
September 30, 2026
Study Completion (Estimated)
September 30, 2027
Study Registration Dates
First Submitted
April 8, 2021
First Submitted That Met QC Criteria
April 14, 2021
First Posted (Actual)
April 19, 2021
Study Record Updates
Last Update Posted (Actual)
July 1, 2026
Last Update Submitted That Met QC Criteria
June 30, 2026
Last Verified
June 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ACL screening
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.