Anterior Cruciate Ligament InjuriesNCT04847258
Rate of Non-copers to Non-surgical ACL Treatment After 3 Months of Rehabilitation
An observational study of Anterior Cruciate Ligament Injuries, run by Vejle Hospital at 1 site in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 49 years
- Conditions the study is for
- Anterior Cruciate Ligament Injuries
- What is being tested?
- Standard rehabilitation
- How many people
- 357 participants
- Where
- 1 siteDenmark
- Study dates
- 19 Mar 2021to 30 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 49 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients will be recruited from the outpatient clinic at the Department of Orthopaedic Surgery at Vejle Hospital, Denmark
Who may be able to join
- unilateral primary ACL injury
- Index injury no older than 6 months
Who cannot join
- Multiligament rupture
- Large cartillage or meniscus injuries
- Scheduled ACL reconstruction within 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Anterior Cruciate Ligament Injuries
- Being tested
- Standard rehabilitation
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard rehabilitationOther
Patients follow standard municipal rehabilitation
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients undergoing ACL reconstruction after 3 months of standard rehabilitation
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2021
- Study start19 Mar 2021
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 357 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vejle Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claus Varnum, ph.d., Study director, Vejle Hosptal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04847258
- Sponsor's protocol ID
- ACL screening
- Status last verified
- Jun 2026
- First submitted
- 8 Apr 2021
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rate of Non-copers to Non-surgical ACL Treatment After 3 Months of Rehabilitation - a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT04847258
- Acronym / sponsor ID
- ACL screening
- Conditions
- Anterior Cruciate Ligament Injuries
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 357 participants (estimated)
- Lead sponsor
- Vejle HospitalUniversity, hospital or other
- Study start
- 19 Mar 2021 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 19 Apr 2021 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients will be recruited from the outpatient clinic at the Department of Orthopaedic Surgery at Vejle Hospital, Denmark
Key inclusion criteria (2 listed)
- unilateral primary ACL injury
- Index injury no older than 6 months
Key exclusion criteria (3 listed)
- Multiligament rupture
- Large cartillage or meniscus injuries
- Scheduled ACL reconstruction within 3 months
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 |
|---|---|---|
| Standard rehabilitationPatients follow standard municipal rehabilitation | Other | – |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Anterior Cruciate Ligament Injuries
Not yet recruiting
Stair Biomechanics and Vibration Study After ACLR
Anterior Cruciate Ligament Reconstruction (ACLR), Anterior Cruciate Ligament Injury
Not yet recruiting
Supporting Athletes' Return to Sports After ACL Reconstruction: A Study of a Psychological Readiness Program
Anterior Cruciate Ligament Reconstruction, Anterior Cruciate Ligament Injuries
Recruiting
Graded Exposure and Mindfulness Meditation for Patients Post-ACL Reconstruction
Anterior Cruciate Ligament Injuries
Not yet recruiting
Clinical and Biological Outcomes of BioBrace-Augmented ACL Reconstruction
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
Not yet recruiting
Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Postoperative Recovery Quality in Patients Undergoing Anterior Cruciate Ligament Reconstruction
Anterior Cruciate Ligament Injuries, Recovery Quality
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.
Claus Varnum, ph.d. study director
Vejle Hosptal
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 Vejle Hospital at 1 site in Denmark.
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 2 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: under way, not looking for participants, as of the sponsor's last update on 1 Jul 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 Denmark. 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?
This study is still under way. Results are not available in the source record yet.
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 patients undergoing ACL reconstruction after 3 months of standard rehabilitation (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jul 2026; AzTrials last refreshed its copy on 8 Nov 2026.