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

April 16, 2024 updated by: Mostafa Hassanein, Msc

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 11517
        • Ain Shams University Hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lysholm knee score
Time Frame: 1 month post operative
knee score from 0 to 100 where a higher score means better outcome.
1 month post operative
Lysholm knee score
Time Frame: 3 month post operative
knee score from 0 to 100 where a higher score means better outcome.
3 month post operative
Lysholm knee score
Time Frame: 6 month post operative
knee score from 0 to 100 where a higher score means better outcome.
6 month post operative
Tegner activity level
Time Frame: 1 month post operative
activity level from 0 to 11 where 11 means highest level
1 month post operative
Tegner activity level
Time Frame: 3 months post operative
activity level from 0 to 11 where 11 means highest level
3 months post operative
Tegner activity level
Time Frame: 6 months post operative
activity level from 0 to 11 where 11 means highest level
6 months post operative
Return to pre injury level
Time Frame: through study completion, an average of 7 months
time needed by the patient in months post operative to return to pre injury activity level
through study completion, an average of 7 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
knee range of motion
Time Frame: pre operative, 1 month, 3months, and 6 months post operative
measure knee range of motion in degrees "flexion and extension"
pre operative, 1 month, 3months, and 6 months post operative
knee stability
Time Frame: pre operative, 1 month, 3months, and 6 months post operative
Lachman knee stability test
pre operative, 1 month, 3months, and 6 months post operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mostafa Hassanein, Msc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2022

Primary Completion (Actual)

September 1, 2023

Study Completion (Actual)

September 1, 2023

Study Registration Dates

First Submitted

March 10, 2023

First Submitted That Met QC Criteria

April 5, 2023

First Posted (Actual)

April 18, 2023

Study Record Updates

Last Update Posted (Actual)

April 18, 2024

Last Update Submitted That Met QC Criteria

April 16, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMASU MD80/2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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