Evaluation of the Results of Two Different Methods in Management of Antero-lateral Instability of the Knee
1 other identifier
interventional
40
1 country
1
Brief Summary
This randomized clinical study will be conducted to compare the results of anterior cruciate ligament reconstruction (ACLR) combined with either anterolateral ligament reconstruction using peroneus longus autograft or extra-articular tenodesis (Modified Lemaire) in management of antero-lateral instability of the knee
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2023
CompletedFirst Submitted
Initial submission to the registry
January 1, 2024
CompletedFirst Posted
Study publicly available on registry
January 25, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2025
CompletedJanuary 25, 2024
January 1, 2024
2 years
January 1, 2024
January 24, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Functional results of knee stability and return to normal activity
IKDC (International Knee Documentation Committee) subjective knee evaluation form
12 months postoperatively
Study Arms (2)
Reconstruction group
ACTIVE COMPARATORPatients with ACL injury and antero-lateral knee instability undergo ACL reconstruction combined with anterolateral ligament reconstruction using peroneus longus autograft
Tenodesis group
ACTIVE COMPARATORPatients with ACL injury and antero-lateral knee instability undergo ACL reconstruction combined with extra-articular tenodesis (Modified Lemaire).
Interventions
ACL reconstruction combined with anterolateral ligament reconstruction using peroneus longus autograft
ACL reconstruction combined with extra-articular tenodesis (Modified Lemaire)
Eligibility Criteria
You may qualify if:
- The ACL deficient knee was clinically manifested by physical examination and confirmed by MRI.
- Age 18-45 years, skeletally mature patient.
- A positive pivot shift test of at least grade II is required (significant anterolateral instability).
You may not qualify if:
- Multiple ligament injuries or a polytraumatized patient
- Revision cases.
- Generalized laxity.
- Symptomatic articular cartilage defect requiring treatment; Outerbridge \> grade II.
- More than three degrees of varus or valgus malalignment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sohag Universitylead
Study Sites (1)
Sohag University
Sohag, Egypt
Related Publications (1)
El-Azab H, Abdelkareem O, Hafez AR, Elsayed M, Ali M. Comparative study between lateral extra-articular tenodesis versus anterolateral ligament reconstruction in combination with anterior cruciate ligament reconstruction. J Orthop Surg Res. 2026 Jan 17. doi: 10.1186/s13018-025-06561-x. Online ahead of print.
PMID: 41547885DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Abdelrahman Hafez, MD
Professor
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant lecturer
Study Record Dates
First Submitted
January 1, 2024
First Posted
January 25, 2024
Study Start
September 1, 2023
Primary Completion
August 31, 2025
Study Completion
August 31, 2025
Last Updated
January 25, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will not share