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

NCT ID: NCT05817084

Last Updated: 2024-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-01

Study Completion Date

2024-03-30

Brief Summary

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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

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Conditions

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ACL - Anterior Cruciate Ligament Deficiency Varus Deformity of Tibia (Disorder) ACL Injury Knee Deformity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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12 patients with varus knee malalignment and acl deficiency under went acl reconstruction and hto

anterior cruciate ligament reconstruction and medial opening wedge high tibial osteotomy in the same session

Group Type ACTIVE_COMPARATOR

medial opening wedge high tibial osteotomy

Intervention Type PROCEDURE

medial opening wedge valgus high tibial osteotomy

anterior cruciate ligament reconstruction

Intervention Type PROCEDURE

anterior cruciate ligament reconstruction

12 patients with varus knee malalignment and acl deficiency underwent acl reconstruction

anterior cruciate ligament reconstruction alone.

Group Type ACTIVE_COMPARATOR

anterior cruciate ligament reconstruction

Intervention Type PROCEDURE

anterior cruciate ligament reconstruction

Interventions

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medial opening wedge high tibial osteotomy

medial opening wedge valgus high tibial osteotomy

Intervention Type PROCEDURE

anterior cruciate ligament reconstruction

anterior cruciate ligament reconstruction

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mostafa Hassanein, Msc

OTHER

Sponsor Role lead

Responsible Party

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Mostafa Hassanein, Msc

principal investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Ain Shams University Hospitals

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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FMASU MD80/2022

Identifier Type: -

Identifier Source: org_study_id

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