Patients With Acl Injury and Varus Knee Will Undergo Acl Reconstruction Alone, or Combined With High Tibial Osteotomy in the Same Session.

Not Applicable

Completed

• Conditions: ACL - Anterior Cruciate Ligament Deficiency; Varus Deformity of Tibia (Disorder); ACL Injury; Knee Deformity
• Interventions: Procedure: anterior cruciate ligament reconstruction; Procedure: medial opening wedge high tibial osteotomy

• Registration Number: NCT05817084
• Lead Sponsor: Mostafa Hassanein, Msc

Brief Summary

The purpose of this study is to compare the results of single-stage anterior cruciate ligament reconstruction combined with high tibial osteotomy and anterior cruciate ligament reconstruction alone in knees with varus malalignment and anterior cruciate ligament deficiency. Evaluation will be clinically, radiologically and time needed to return to pre injury activity level. Our Hypothesis: Simultaneous anterior cruciate ligament reconstruction and high tibial osteotomy provides good functional scores, low rate of graft failure and early return to pre injury activity level with minimal added morbidity.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-01
• Study First Submitted: 2023-03-10
• Study First Submitted QC: 2023-04-05
• Study First Posted: 2023-04-18
• Primary Completion: 2024-03-30
• Study Completion: 2024-03-30
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-04
• Last Update Posted: 2024-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Age between 20 and 50.
• Knee varus malalignment 7-10°.
• ACL injury with clinical anterior instability confirmed by MRI.

Exclusion Criteria

• Osteoarthritis (Kellgren-Lawrence grade IV).
• Inflammatory joint disease.
• Knee flexion < 120°
• Knee fixed flexion deformity > 10°.
• BMI >30
• Any ligamentous or meniscal knee injury other than ACL injury.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
12 patients with varus knee malalignment and acl deficiency underwent acl reconstruction	anterior cruciate ligament reconstruction	anterior cruciate ligament reconstruction alone.
12 patients with varus knee malalignment and acl deficiency under went acl reconstruction and hto	medial opening wedge high tibial osteotomy	anterior cruciate ligament reconstruction and medial opening wedge high tibial osteotomy in the same session
12 patients with varus knee malalignment and acl deficiency under went acl reconstruction and hto	anterior cruciate ligament reconstruction	anterior cruciate ligament reconstruction and medial opening wedge high tibial osteotomy in the same session

Primary Outcome Measures

Name	Time	Method
Lysholm knee score	6 month post operative	knee score from 0 to 100 where a higher score means better outcome.
Return to pre injury level	through study completion, an average of 7 months	time needed by the patient in months post operative to return to pre injury activity level
Tegner activity level	6 months post operative	activity level from 0 to 11 where 11 means highest level

Secondary Outcome Measures

Name	Time	Method
knee range of motion	pre operative, 1 month, 3months, and 6 months post operative	measure knee range of motion in degrees "flexion and extension"
knee stability	pre operative, 1 month, 3months, and 6 months post operative	Lachman knee stability test

Trial Locations

Locations (1)

Ain Shams University Hospitals; 🇪🇬 Cairo, Egypt