Back to resultsReconstruction of the Anterolateral Ligament (ALL) With Revision Anterior Cruciate Ligament (ACL) Surgery
Primary Purpose
Rupture of Anterior Cruciate Ligament, Anterolateral Ligament Reconstruction
Status
Active
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
ALL reconstruction (Anterolateral ligament)
ACL revision (Anterior cruciate ligament )
Sponsored by
About this trial
This is an interventional health services research trial for Rupture of Anterior Cruciate Ligament focused on measuring Laxity, Knee, Rupture, ALL
Eligibility Criteria
Inclusion Criteria:
- Patients with ACL revision surgery indication
Exclusion Criteria:
- Patients with difficulties of understanding danish
Sites / Locations
- Division of Sports Trauma, Tage-Hansens Gade 2b
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Isolated ACL-revision
Combined ACL and ALL surgery
Arm Description
The standard operation with an isolated Anterior cruciate ligament.
An operation with an Anterior cruciate ligament combined with an anterolateral ligament.
Outcomes
Primary Outcome Measures
Difference in The Knee Numeric-Entity Evaluation Score (KNEES)
questionaire
Secondary Outcome Measures
Difference in Knee injury and Osteoarthritis Outcome Score (KOOS)
questionaire
Difference in KT-1000
Objective Knee stability
Difference in TEGNER functional score
questionaire
Full Information
NCT ID
NCT02680821
First Posted
February 8, 2016
Last Updated
July 31, 2023
Sponsor
Aarhus University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02680821
Brief Title
Reconstruction of the Anterolateral Ligament (ALL) With Revision Anterior Cruciate Ligament (ACL) Surgery
Official Title
Effect of Reconstruction of the Anterolateral Ligament (ALL) in Combination With Revision Anterior Cruciate Ligament (ACL) Surgery. A Clinical Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 2016 (undefined)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aarhus University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rupture of Anterior Cruciate Ligament, Anterolateral Ligament Reconstruction
Keywords
Laxity, Knee, Rupture, ALL
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
102 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Isolated ACL-revision
Arm Type
Other
Arm Description
The standard operation with an isolated Anterior cruciate ligament.
Arm Title
Combined ACL and ALL surgery
Arm Type
Other
Arm Description
An operation with an Anterior cruciate ligament combined with an anterolateral ligament.
Intervention Type
Procedure
Intervention Name(s)
ALL reconstruction (Anterolateral ligament)
Intervention Type
Procedure
Intervention Name(s)
ACL revision (Anterior cruciate ligament )
Primary Outcome Measure Information:
Title
Difference in The Knee Numeric-Entity Evaluation Score (KNEES)
Description
questionaire
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Difference in Knee injury and Osteoarthritis Outcome Score (KOOS)
Description
questionaire
Time Frame
12 Months
Title
Difference in KT-1000
Description
Objective Knee stability
Time Frame
12 Months
Title
Difference in TEGNER functional score
Description
questionaire
Time Frame
12 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with ACL revision surgery indication
Exclusion Criteria:
Patients with difficulties of understanding danish
Facility Information:
Facility Name
Division of Sports Trauma, Tage-Hansens Gade 2b
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
Reconstruction of the Anterolateral Ligament (ALL) With Revision Anterior Cruciate Ligament (ACL) Surgery
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