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

M

Mostafa Hassanein, Msc

Status

Completed

Conditions

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

Treatments

Procedure: anterior cruciate ligament reconstruction
Procedure: medial opening wedge high tibial osteotomy

Study type

Interventional

Funder types

Other

Identifiers

NCT05817084
FMASU MD80/2022

Details and patient eligibility

About

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.

Enrollment

24 patients

Sex

All

Ages

20 to 50 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

24 participants in 2 patient groups

12 patients with varus knee malalignment and acl deficiency under went acl reconstruction and hto
Active Comparator group
Description:
anterior cruciate ligament reconstruction and medial opening wedge high tibial osteotomy in the same session
Treatment:
Procedure: medial opening wedge high tibial osteotomy
Procedure: anterior cruciate ligament reconstruction
12 patients with varus knee malalignment and acl deficiency underwent acl reconstruction
Active Comparator group
Description:
anterior cruciate ligament reconstruction alone.
Treatment:
Procedure: anterior cruciate ligament reconstruction

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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