Back to resultsPatients With Acl Injury and Varus Knee Will Undergo Acl Reconstruction Alone, or Combined With High Tibial Osteotomy in the Same Session.
Primary Purpose
ACL - Anterior Cruciate Ligament Deficiency, Varus Deformity of Tibia (Disorder), ACL Injury
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
medial opening wedge high tibial osteotomy
anterior cruciate ligament reconstruction
Sponsored by
About this trial
This is an interventional treatment trial for ACL - Anterior Cruciate Ligament Deficiency
Eligibility Criteria
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.
Sites / Locations
- Ain Shams University Hospitals
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
12 patients with varus knee malalignment and acl deficiency under went acl reconstruction and hto
12 patients with varus knee malalignment and acl deficiency underwent acl reconstruction
Arm Description
anterior cruciate ligament reconstruction and medial opening wedge high tibial osteotomy in the same session
anterior cruciate ligament reconstruction alone.
Outcomes
Primary Outcome Measures
Lysholm knee score
knee score from 0 to 100 where a higher score means better outcome.
Lysholm knee score
knee score from 0 to 100 where a higher score means better outcome.
Lysholm knee score
knee score from 0 to 100 where a higher score means better outcome.
Tegner activity level
activity level from 0 to 11 where 11 means highest level
Tegner activity level
activity level from 0 to 11 where 11 means highest level
Tegner activity level
activity level from 0 to 11 where 11 means highest level
Return to pre injury level
time needed by the patient in months post operative to return to pre injury activity level
Secondary Outcome Measures
knee range of motion
measure knee range of motion in degrees "flexion and extension"
knee stability
Lachman knee stability test
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05817084
Brief Title
Patients With Acl Injury and Varus Knee Will Undergo Acl Reconstruction Alone, or Combined With High Tibial Osteotomy in the Same Session.
Official Title
Outcomes of Anterior Cruciate Ligament Reconstruction With and Without High Tibial Osteotomy in Knees With Varus Malalignment. Comparative Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
January 7, 2023 (Actual)
Study Completion Date
March 5, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mostafa Hassanein, Msc
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ACL - Anterior Cruciate Ligament Deficiency, Varus Deformity of Tibia (Disorder), ACL Injury, Knee Deformity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
12 patients with varus knee malalignment and acl deficiency under went acl reconstruction and hto
Arm Type
Active Comparator
Arm Description
anterior cruciate ligament reconstruction and medial opening wedge high tibial osteotomy in the same session
Arm Title
12 patients with varus knee malalignment and acl deficiency underwent acl reconstruction
Arm Type
Active Comparator
Arm Description
anterior cruciate ligament reconstruction alone.
Intervention Type
Procedure
Intervention Name(s)
medial opening wedge high tibial osteotomy
Intervention Description
medial opening wedge valgus high tibial osteotomy
Intervention Type
Procedure
Intervention Name(s)
anterior cruciate ligament reconstruction
Intervention Description
anterior cruciate ligament reconstruction
Primary Outcome Measure Information:
Title
Lysholm knee score
Description
knee score from 0 to 100 where a higher score means better outcome.
Time Frame
1 month post operative
Title
Lysholm knee score
Description
knee score from 0 to 100 where a higher score means better outcome.
Time Frame
3 month post operative
Title
Lysholm knee score
Description
knee score from 0 to 100 where a higher score means better outcome.
Time Frame
6 month post operative
Title
Tegner activity level
Description
activity level from 0 to 11 where 11 means highest level
Time Frame
1 month post operative
Title
Tegner activity level
Description
activity level from 0 to 11 where 11 means highest level
Time Frame
3 months post operative
Title
Tegner activity level
Description
activity level from 0 to 11 where 11 means highest level
Time Frame
6 months post operative
Title
Return to pre injury level
Description
time needed by the patient in months post operative to return to pre injury activity level
Time Frame
through study completion, an average of 7 months
Secondary Outcome Measure Information:
Title
knee range of motion
Description
measure knee range of motion in degrees "flexion and extension"
Time Frame
pre operative, 1 month, 3months, and 6 months post operative
Title
knee stability
Description
Lachman knee stability test
Time Frame
pre operative, 1 month, 3months, and 6 months post operative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Ain Shams University Hospitals
City
Cairo
ZIP/Postal Code
11517
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Patients With Acl Injury and Varus Knee Will Undergo Acl Reconstruction Alone, or Combined With High Tibial Osteotomy in the Same Session.
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