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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05817084
Other study ID # FMASU MD80/2022
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 1, 2022
Est. completion date September 1, 2023

Study information

Verified date April 2024
Source Ain Shams University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date September 1, 2023
Est. primary completion date September 1, 2023
Accepts healthy volunteers No
Gender All
Age group 20 Years to 50 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Egypt Ain Shams University Hospitals Cairo

Sponsors (1)

Lead Sponsor Collaborator
Mostafa Hassanein, Msc

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Lysholm knee score knee score from 0 to 100 where a higher score means better outcome. 1 month post operative
Primary Lysholm knee score knee score from 0 to 100 where a higher score means better outcome. 3 month post operative
Primary Lysholm knee score knee score from 0 to 100 where a higher score means better outcome. 6 month post operative
Primary Tegner activity level activity level from 0 to 11 where 11 means highest level 1 month post operative
Primary Tegner activity level activity level from 0 to 11 where 11 means highest level 3 months post operative
Primary Tegner activity level activity level from 0 to 11 where 11 means highest level 6 months post operative
Primary Return to pre injury level 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 knee range of motion measure knee range of motion in degrees "flexion and extension" pre operative, 1 month, 3months, and 6 months post operative
Secondary knee stability Lachman knee stability test pre operative, 1 month, 3months, and 6 months post operative
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