Anterior Cruciate Ligament RuptureNCT04644497
Comparison of Different Anterior Cruciate Ligament Surgery Techniques in Skeletally Immature Patients.
An observational study of Anterior Cruciate Ligament Rupture, run by Aarhus University Hospital at 1 site in Denmark.
Trial summary
This cohort study compares to groups of patients with reconstruction of anterior cruciate ligament (ACL). Patients in group 1 had ACL-reconstruction in the years 2001-2010 with a transphyseal drilling technique. Patient in group 2 had ACL-reconstruction in the years 2013-2018 with a physeal sparing technique. Read more about this study
- Who is it for?
- Ages 16 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Anterior Cruciate Ligament Rupture
- What is being tested?
- ACL-reconstruction
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 1 siteDenmark
- Study dates
- 31 Jan 2021to 30 Jul 2025
- 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 16 to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Study population: -ACL-reconstruction in one knee, operated in to periods (2001-2010 or 2013-2018) with two different techniques in each period.
Who may be able to join
- ACL reconstruction as skeletally immature
Who cannot join
- Other ligament injuries in index knee
- Other ligament injuries in opposite knee
- Revision ACL reconstruction
- Pregnant
- Not able to read or understand the danish languages
Trial locations and contacts
1 site in 1 country.
About this study
This cohort study compares to groups of patients with reconstruction of anterior cruciate ligament (ACL). Patients in group 1 had ACL-reconstruction in the years 2001-2010 with a transphyseal drilling technique. Patient in group 2 had ACL-reconstruction in the years 2013-2018 with a physeal sparing technique.
Data including: x-ray exam, patient reported questionnaires and clinical evaluation will be compared between the 2 groups.
- Conditions
- Anterior Cruciate Ligament Rupture
- Being tested
- ACL-reconstruction
- 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.
ACL-reconstructionProcedure or surgery
Surgery technique in skeletally immature patients
| Study group | Role | What they receive |
|---|---|---|
| Transphyseal drilling technique | Not described Receives: Procedure: ACL-reconstruction | |
| Physeal sparing drilling technique | Not described Receives: Procedure: ACL-reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Leg-length differences
X-ray evaluation
Measured: 2 Years Follow-up
Knee Angle differences
X-ray evaluation
Measured: 2 Years Follow-up
Secondary outcomes (4)
Knee Laxity
Clinical evaluation with rolimeter (arthrometer)
Measured: 2 Years Follow-up
IKDC-Questionnaire
The International Knee Documentation Committee (IKDC Questionnaire)
Measured: 2 Years Follow-up
Tegner-Questionnaire
Tegner (Activity function score)
Measured: 2 Years Follow-up
KOOS- Questionnaire
Knee injury and Osteoarthritis Outcome Score (KOOS)
Measured: 2 Years Follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2020
- Study start31 Jan 2021
- Primary completion31 Aug 2023
- Study completion30 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament RuptureStudies 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
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin Lind, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04644497
- Sponsor's protocol ID
- EC 1-10-72-246-20
- Status last verified
- Sep 2025
- First submitted
- 16 Nov 2020
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
- Comparison of Different Anterior Cruciate Ligament Surgery Techniques in Skeletally Immature Patients.
- ClinicalTrials.gov ID
- NCT04644497
- Acronym / sponsor ID
- EC 1-10-72-246-20
- Conditions
- Anterior Cruciate Ligament Rupture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Study start
- 31 Jan 2021 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 30 Jul 2025 (actual)
- First posted
- 25 Nov 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.
This cohort study compares to groups of patients with reconstruction of anterior cruciate ligament (ACL). Patients in group 1 had ACL-reconstruction in the years 2001-2010 with a transphyseal drilling technique. Patient in group 2 had ACL-reconstruction in the years 2013-2018 with a physeal sparing technique.
Data including: x-ray exam, patient reported questionnaires and clinical evaluation will be compared between the 2 groups.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transphyseal drilling technique | – | Procedure: ACL-reconstruction |
| Physeal sparing drilling technique | – | Procedure: ACL-reconstruction |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Study population: -ACL-reconstruction in one knee, operated in to periods (2001-2010 or 2013-2018) with two different techniques in each period.
Key inclusion criteria (1 listed)
- ACL reconstruction as skeletally immature
Key exclusion criteria (5 listed)
- Other ligament injuries in index knee
- Other ligament injuries in opposite knee
- Revision ACL reconstruction
- Pregnant
- Not able to read or understand the danish languages
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 |
|---|---|---|
| ACL-reconstructionSurgery technique in skeletally immature patients | Procedure or surgery | Physeal sparing drilling technique, Transphyseal drilling technique |
Primary outcome
Leg-length differences
Time frame: 2 Years Follow-up
X-ray evaluation
Knee Angle differences
Time frame: 2 Years Follow-up
X-ray evaluation
4 secondary outcomes
Knee Laxity
Time frame: 2 Years Follow-up
IKDC-Questionnaire
Time frame: 2 Years Follow-up
Tegner-Questionnaire
Time frame: 2 Years Follow-up
KOOS- Questionnaire
Time frame: 2 Years Follow-up
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 1 Oct 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Rupture, 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 5 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 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?
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?
Leg-length differences (time frame: 2 Years Follow-up). The study lists 2 primary outcomes in all. 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.