ACL InjuryNCT04408885
Rehabilitation Treatment of Anterior Cruciate Ligament Rupture
An observational study of ACL Injury, run by Aarhus University Hospital at 1 site in Denmark.
Trial summary
The purpose with this present study is to investigate the effect og a non-surgical regime in patients with an Anterior Cruciate ligament injury. The effect will be measured by patient reported outcome scores, level of function and how many of the patients are converting to operative treatment. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- ACL Injury
- What is being tested?
- Rehabilitation
- How many people
- 400 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Aug 2020to 31 Dec 2030
- How long will I take part?
- 5 Years
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: We will include 400 patients with Anterior cruciate ligament injury. Patients will be included at different orthopaedic Clinics at 5 hospitals in Region Midtjylland.
Who may be able to join
- Anterior cruciate ligament injury where rehabilitation regime is selected as treatment.
Who cannot join
- Other knee ligament instability
- Rheumatoid arthritis
- Morbus Bechterews Disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Division of Sports Trauma, Palle Juul-Jensens Boulevard 99
Aarhus N, 8200
Martin Lind, Professor, +45 30248244, martli@rm.dk
Torsten Nielsen, coordinator, +45 40491184, torsne@rm.dk
About this study
The purpose with this present study is to investigate the effect og a non-surgical regime in patients with an Anterior Cruciate ligament injury.
The effect will be measured by patient reported outcome scores, level of function and how many of the patients are converting to operative treatment.
- Conditions
- ACL Injury
- Being tested
- 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.
RehabilitationOther
Non-surgical interventions to patients with an Anterior cruciate ligament injury. Rehabilitation regime is the regime provided by the physician at the rehabilitation clinic.
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in patient reported outcome score (IKDC)
The International Knee Documentation Committee (0-100)
Measured: Baseline - 2 Years
Secondary outcomes (3)
Changes in patient reported outcome score (KOOS)
Knee injury and Osteoarthritis Outcome Score (0-100)
Measured: Baseline - 2 Years
Changes in patient reported outcome score (KNEES-ACL)
Knee Numeric-Entity Evaluation Score (0-100)
Measured: Baseline - 2 Years
Changes in patient reported outcome score (TEGNER)
Activity scale (0-10)
Measured: Baseline - 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2020
- Study start15 Aug 2020
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ACL InjuryStudies of the same condition, open and under way.
- More trials run by Aarhus University HospitalThe sponsor's other registered studies.
- 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
- 400 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Horsens Hospital, Central Jutland Regional Hospital, Regionshospitalet Silkeborg, Herning Hospital
- Responsible party
- Principal investigator, Martin Lind, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04408885
- Sponsor's protocol ID
- Danish EC: 1-10-72-25-20
- Status last verified
- Sep 2025
- First submitted
- 26 May 2020
- Last updated
- 1 Oct 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will not be available for other researchers
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitation Treatment of Anterior Cruciate Ligament Rupture
- ClinicalTrials.gov ID
- NCT04408885
- Acronym / sponsor ID
- Danish EC: 1-10-72-25-20
- Conditions
- ACL Injury
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Collaborators
- Horsens Hospital, Central Jutland Regional Hospital, Regionshospitalet Silkeborg, Herning Hospital
- Study start
- 15 Aug 2020 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 29 May 2020 (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 purpose with this present study is to investigate the effect og a non-surgical regime in patients with an Anterior Cruciate ligament injury.
The effect will be measured by patient reported outcome scores, level of function and how many of the patients are converting to operative treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- We will include 400 patients with Anterior cruciate ligament injury. Patients will be included at different orthopaedic Clinics at 5 hospitals in Region Midtjylland.
Key inclusion criteria (1 listed)
- Anterior cruciate ligament injury where rehabilitation regime is selected as treatment.
Key exclusion criteria (3 listed)
- Other knee ligament instability
- Rheumatoid arthritis
- Morbus Bechterews Disease
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 |
|---|---|---|
| RehabilitationNon-surgical interventions to patients with an Anterior cruciate ligament injury. Rehabilitation regime is the regime provided by the physician at the rehabilitation clinic. | Other | – |
Primary outcome
Changes in patient reported outcome score (IKDC)
Time frame: Baseline - 2 Years
The International Knee Documentation Committee (0-100)
3 secondary outcomes
Changes in patient reported outcome score (KOOS)
Time frame: Baseline - 2 Years
Changes in patient reported outcome score (KNEES-ACL)
Time frame: Baseline - 2 Years
Changes in patient reported outcome score (TEGNER)
Time frame: Baseline - 2 Years
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 Oct 2025.
- Individual participant dataSharing planned: No. Data will not be available for other researchers
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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.
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 ACL Injury, run by Aarhus University 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 1 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: looking for participants now, as of the sponsor's last update on 1 Oct 2025. 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?
Contact Torsten G Nielsen, PT (+4540491184, torsne@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in patient reported outcome score (IKDC) (time frame: Baseline - 2 Years). 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 Oct 2025.