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

Outcomes of Anterior Cruciate Ligament Reconstruction With and Without High Tibial Osteotomy in Knees With Varus Malalignment. Comparative Study

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05817084

Enrollment

Registered

2023-04-18

Start date

2022-04-01

Completion date

2024-03-30

Last updated

2024-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

PROCEDUREmedial opening wedge high tibial osteotomy

medial opening wedge valgus high tibial osteotomy

PROCEDUREanterior cruciate ligament reconstruction

anterior cruciate ligament reconstruction

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 50 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Lysholm knee score	1 month post operative	knee score from 0 to 100 where a higher score means better outcome.
Tegner activity level	1 month post operative	activity level from 0 to 11 where 11 means highest level
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

Secondary

Measure	Time frame	Description
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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026