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

ACL Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05817084
• Other study ID #: FMASU MD80/2022
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• ACL - Anterior Cruciate Ligament Deficiency
• ACL Injury
• Anterior Cruciate Ligament Injuries
• Congenital Abnormalities
• Knee Deformity

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