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OpenTrials
Completed

NCT Number: NCT05817084

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

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.

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Key information

Conditions

ACL - Anterior Cruciate Ligament Deficiency ACL Injury Anterior Cruciate Ligament Injuries Knee Deformity Knee Injuries Leg Injuries Varus Deformity of Tibia (Disorder) Wounds and Injuries

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams University Hospitals

Cairo, 11517, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

medial opening wedge high tibial osteotomy

Procedure

medial opening wedge valgus high tibial osteotomy

anterior cruciate ligament reconstruction

Procedure

anterior cruciate ligament reconstruction

Primary outcomes

  1. Lysholm knee score

    Time frame: 1 month post operative

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

  2. Lysholm knee score

    Time frame: 3 month post operative

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

  3. Lysholm knee score

    Time frame: 6 month post operative

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

  4. Tegner activity level

    Time frame: 1 month post operative

    activity level from 0 to 11 where 11 means highest level

  5. Tegner activity level

    Time frame: 3 months post operative

    activity level from 0 to 11 where 11 means highest level

  6. Tegner activity level

    Time frame: 6 months post operative

    activity level from 0 to 11 where 11 means highest level

  7. 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

Secondary outcomes

  1. 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"

  2. knee stability

    Time frame: pre operative, 1 month, 3months, and 6 months post operative

    Lachman knee stability test

Sponsors and collaborators

Lead sponsor

Mostafa Hassanein, Msc

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Apr 18, 2023
Registry last updated
Jul 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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