Skip to main content
Clinical Trials/NCT05817084
NCT05817084
Completed
Not Applicable

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

Mostafa Hassanein, Msc1 site in 1 country24 target enrollmentApril 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
ACL - Anterior Cruciate Ligament Deficiency
Sponsor
Mostafa Hassanein, Msc
Enrollment
24
Locations
1
Primary Endpoint
Lysholm knee score
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2022
End Date
March 30, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Mostafa Hassanein, Msc
Responsible Party
Sponsor Investigator
Principal Investigator

Mostafa Hassanein, Msc

principal investigator

Ain Shams University

Eligibility Criteria

Inclusion Criteria

  • Age between 20 and
  • 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°.
  • Any ligamentous or meniscal knee injury other than ACL injury.

Outcomes

Primary Outcomes

Lysholm knee score

Time Frame: 6 month post operative

knee score from 0 to 100 where a higher score means better outcome.

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

Tegner activity level

Time Frame: 6 months post operative

activity level from 0 to 11 where 11 means highest level

Secondary Outcomes

  • knee range of motion(pre operative, 1 month, 3months, and 6 months post operative)
  • knee stability(pre operative, 1 month, 3months, and 6 months post operative)

Study Sites (1)

Loading locations...

Similar Trials