Rupture of Anterior Cruciate LigamentNCT02680821
Reconstruction of the Anterolateral Ligament (ALL) With Revision Anterior Cruciate Ligament (ACL) Surgery
A study testing ALL reconstruction (Anterolateral ligament) and ACL revision (Anterior cruciate ligament ) in people with Rupture of Anterior Cruciate Ligament and Anterolateral Ligament Reconstruction, run by Aarhus University Hospital at 1 site in Denmark.
Trial summary
Patients with combined Anterolateral ligament (ALL) reconstruction- Anterior cruciate ligament (ACL) revision will have a better rotational knee stability and therefore better patient reported outcome measure (PROM) scores compared to patients, who have ACL revision surgery without ALL reconstruction. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Rupture of Anterior Cruciate Ligament, Anterolateral Ligament Reconstruction
- What is being tested?
- ALL reconstruction (Anterolateral ligament) and ACL revision (Anterior cruciate ligament )
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2016to Sep 2024
- Phase
- Interventional
- 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with ACL revision surgery indication
Who cannot join
- Patients with difficulties of understanding danish
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Reconstruction of the Anterolateral Ligament (ALL) in Combination With Revision Anterior Cruciate Ligament (ACL) Surgery. A Clinical Randomized Trial
Patients with combined Anterolateral ligament (ALL) reconstruction- Anterior cruciate ligament (ACL) revision will have a better rotational knee stability and therefore better patient reported outcome measure (PROM) scores compared to patients, who have ACL revision surgery without ALL reconstruction.
- Being tested
- ALL reconstruction (Anterolateral ligament), ACL revision (Anterior cruciate ligament )
- Keywords
- Laxity, Knee, Rupture, ALL
- Medical subject headings
- Anterior Cruciate Ligament Injuries, Rupture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALL reconstruction (Anterolateral ligament)Procedure or surgery
ACL revision (Anterior cruciate ligament )Procedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Isolated ACL-revision | Other | The standard operation with an isolated Anterior cruciate ligament. Receives: Procedure: ACL revision (Anterior cruciate ligament ) |
| Combined ACL and ALL surgery | Other | An operation with an Anterior cruciate ligament combined with an anterolateral ligament. Receives: Procedure: ALL reconstruction (Anterolateral ligament); Procedure: ACL revision (Anterior cruciate ligament ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in The Knee Numeric-Entity Evaluation Score (KNEES)
questionaire
Measured: 12 months
Secondary outcomes (3)
Difference in Knee injury and Osteoarthritis Outcome Score (KOOS)
questionaire
Measured: 12 Months
Difference in KT-1000
Objective Knee stability
Measured: 12 Months
Difference in TEGNER functional score
questionaire
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionSep 2024
- Study completionSep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rupture of Anterior Cruciate LigamentStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 102 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
- NCT02680821
- Sponsor's protocol ID
- Danish EC - 1107232415
- Status last verified
- Sep 2025
- First submitted
- 8 Feb 2016
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Reconstruction of the Anterolateral Ligament (ALL) in Combination With Revision Anterior Cruciate Ligament (ACL) Surgery. A Clinical Randomized Trial
- ClinicalTrials.gov ID
- NCT02680821
- Acronym / sponsor ID
- Danish EC - 1107232415
- Keywords
- Laxity, Knee, Rupture, ALL
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Study start
- Feb 2016 (actual)
- Primary completion
- Sep 2024 (actual)
- Study completion
- Sep 2024 (actual)
- First posted
- 12 Feb 2016 (estimated)
- 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.
Patients with combined Anterolateral ligament (ALL) reconstruction- Anterior cruciate ligament (ACL) revision will have a better rotational knee stability and therefore better patient reported outcome measure (PROM) scores compared to patients, who have ACL revision surgery without ALL reconstruction.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Isolated ACL-revision | Other | Procedure: ACL revision (Anterior cruciate ligament )The standard operation with an isolated Anterior cruciate ligament. |
| Combined ACL and ALL surgery | Other | Procedure: ALL reconstruction (Anterolateral ligament), Procedure: ACL revision (Anterior cruciate ligament )An operation with an Anterior cruciate ligament combined with an anterolateral ligament. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients with ACL revision surgery indication
Key exclusion criteria (1 listed)
- Patients with difficulties of understanding danish
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 |
|---|---|---|
| ALL reconstruction (Anterolateral ligament) | Procedure or surgery | Combined ACL and ALL surgery |
| ACL revision (Anterior cruciate ligament ) | Procedure or surgery | Combined ACL and ALL surgery, Isolated ACL-revision |
Primary outcome
Difference in The Knee Numeric-Entity Evaluation Score (KNEES)
Time frame: 12 months
questionaire
3 secondary outcomes
Difference in Knee injury and Osteoarthritis Outcome Score (KOOS)
Time frame: 12 Months
Difference in KT-1000
Time frame: 12 Months
Difference in TEGNER functional score
Time frame: 12 Months
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 3 Oct 2025.
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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?
A study testing ALL reconstruction (Anterolateral ligament) and ACL revision (Anterior cruciate ligament ) in people with Rupture of Anterior Cruciate Ligament and Anterolateral Ligament Reconstruction, 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 1 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 3 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?
Difference in The Knee Numeric-Entity Evaluation Score (KNEES) (time frame: 12 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 3 Oct 2025.