Reconstruction of the Anterolateral Ligament (ALL) With Revision Anterior Cruciate Ligament (ACL) Surgery

• Sponsor: Aarhus University Hospital (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT02680821
• Collaborator: (none)
• Enrollment: 102
• Location: 1
• Arms: 2
• Duration (Months): 103
• Patients Per Site Per Month: 1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Rupture of Anterior Cruciate Ligament; Anterolateral Ligament Reconstruction	Procedure: ALL reconstruction (Anterolateral ligament); Procedure: ACL revision (Anterior cruciate ligament )	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 102 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Health Services Research
• Official Title: Effect of Reconstruction of the Anterolateral Ligament (ALL) in Combination With Revision Anterior Cruciate Ligament (ACL) Surgery. A Clinical Randomized Trial
• Study Start Date: Feb 1, 2016
• Anticipated Primary Completion Date: Sep 1, 2024
• Anticipated Study Completion Date: Sep 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Other: Isolated ACL-revision The standard operation with an isolated Anterior cruciate ligament.	Procedure: ACL revision (Anterior cruciate ligament )
Other: Combined ACL and ALL surgery An operation with an Anterior cruciate ligament combined with an anterolateral ligament.	Procedure: ALL reconstruction (Anterolateral ligament); Procedure: ACL revision (Anterior cruciate ligament )

Outcome Measures

Primary Outcome Measures

1. Difference in The Knee Numeric-Entity Evaluation Score (KNEES) [12 months]

   questionaire

Secondary Outcome Measures

1. Difference in Knee injury and Osteoarthritis Outcome Score (KOOS) [12 Months]

   questionaire

2. Difference in KT-1000 [12 Months]

   Objective Knee stability

3. Difference in TEGNER functional score [12 Months]

   questionaire

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients with ACL revision surgery indication

Exclusion Criteria:

• Patients with difficulties of understanding danish

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Division of Sports Trauma, Tage-Hansens Gade 2b	Aarhus		Denmark	8000

Sponsors and Collaborators

• Aarhus University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Martin Lind, Professor, Aarhus University Hospital
• ClinicalTrials.gov Identifier: NCT02680821
• Other Study ID Numbers: Danish EC - 1107232415
• First Posted: Feb 12, 2016
• Last Update Posted: Feb 16, 2022
• Last Verified: Feb 1, 2022

• Keywords provided by Martin Lind, Professor, Aarhus University Hospital: Laxity; Knee; Rupture; ALL
• Additional relevant MeSH terms: Rupture

Study Results

No Results Posted as of Feb 16, 2022