- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02680821
Reconstruction of the Anterolateral Ligament (ALL) With Revision Anterior Cruciate Ligament (ACL) Surgery
September 30, 2025 updated by: Martin Lind, Aarhus University Hospital
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.
Study Overview
Status
Completed
Study Type
Interventional
Enrollment (Actual)
102
Phase
- Not Applicable
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
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-
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Aarhus, Denmark, 8000
- Division of Sports Trauma, Tage-Hansens Gade 2b
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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
14 years to 46 years (Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Patients with ACL revision surgery indication
Exclusion Criteria:
- Patients with difficulties of understanding danish
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
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Isolated ACL-revision
The standard operation with an isolated Anterior cruciate ligament.
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Other: Combined ACL and ALL surgery
An operation with an Anterior cruciate ligament combined with an anterolateral ligament.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Difference in The Knee Numeric-Entity Evaluation Score (KNEES)
Time Frame: 12 months
|
questionaire
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Difference in Knee injury and Osteoarthritis Outcome Score (KOOS)
Time Frame: 12 Months
|
questionaire
|
12 Months
|
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Difference in KT-1000
Time Frame: 12 Months
|
Objective Knee stability
|
12 Months
|
|
Difference in TEGNER functional score
Time Frame: 12 Months
|
questionaire
|
12 Months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
February 1, 2016
Primary Completion (Actual)
September 1, 2024
Study Completion (Actual)
September 1, 2024
Study Registration Dates
First Submitted
February 8, 2016
First Submitted That Met QC Criteria
February 11, 2016
First Posted (Estimated)
February 12, 2016
Study Record Updates
Last Update Posted (Estimated)
October 3, 2025
Last Update Submitted That Met QC Criteria
September 30, 2025
Last Verified
September 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Danish EC - 1107232415
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.