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

Sponsor

Mostafa Hassanein, Msc (Other)

Overall Status

Completed

CT.gov ID

NCT05817084

Collaborator

(none)

Enrollment

Location

Arms

11.1

Actual Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
ACL - Anterior Cruciate Ligament Deficiency Varus Deformity of Tibia (Disorder) ACL Injury Knee Deformity	Procedure: medial opening wedge high tibial osteotomy Procedure: anterior cruciate ligament reconstruction	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 1, 2022

Actual Primary Completion Date :

Jan 7, 2023

Actual Study Completion Date :

Mar 5, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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	Procedure: medial opening wedge high tibial osteotomy medial opening wedge valgus high tibial osteotomy Procedure: anterior cruciate ligament reconstruction anterior cruciate ligament reconstruction
Active Comparator: 12 patients with varus knee malalignment and acl deficiency underwent acl reconstruction anterior cruciate ligament reconstruction alone.	Procedure: anterior cruciate ligament reconstruction anterior cruciate ligament reconstruction

Arm

Intervention/Treatment

Active Comparator: 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

Procedure: medial opening wedge high tibial osteotomy

medial opening wedge valgus high tibial osteotomy

Procedure: anterior cruciate ligament reconstruction

anterior cruciate ligament reconstruction

Active Comparator: 12 patients with varus knee malalignment and acl deficiency underwent acl reconstruction

anterior cruciate ligament reconstruction alone.

Procedure: anterior cruciate ligament reconstruction

anterior cruciate ligament reconstruction

Outcome Measures

Primary Outcome Measures

Lysholm knee score [1 month post operative]
knee score from 0 to 100 where a higher score means better outcome.
Lysholm knee score [3 month post operative]
knee score from 0 to 100 where a higher score means better outcome.
Lysholm knee score [6 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
Tegner activity level [3 months post operative]
activity level from 0 to 11 where 11 means highest level
Tegner activity level [6 months 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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 50 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ain Shams University Hospitals	Cairo		Egypt	11517

Sponsors and Collaborators

Mostafa Hassanein, Msc

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mostafa Hassanein, Msc, principal investigator, Ain Shams University

ClinicalTrials.gov Identifier:

NCT05817084

Other Study ID Numbers:

FMASU MD80/2022

First Posted:

Apr 18, 2023

Last Update Posted:

Apr 18, 2023

Last Verified:

Apr 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Congenital Abnormalities

Anterior Cruciate Ligament Injuries

Study Results

No Results Posted as of Apr 18, 2023