Objective Results of Anterior Cruciate Ligament Reconstruction With and Without Internal Suture Augmentation Technique

Study Overview
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Brief Summary
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The purpose of this study is (1) To report, compare and corelate the patient reported outcomes (PRO) (IKDC score, Lysholm Score) and range of motion (ROM) among patients following hamstring autograft ACLR with and without independent suture tape reinforcement against objective laxity test using Lachmeter. (2) Rate of complications and reoperation.

Detailed Description
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Investigators performed a randomized control trial in two groups utilizing All- inside ACLR. Group I was augmented by suture tape and Group 2 without suture tape augmentation. From October 2018 to June 2020, 20 patients underwent all-inside ACL reconstruction with internal suture augmentation technique (Group I, Brace group) and the other 18 patients underwent all- inside ACL reconstruction without internal suture augmentation technique (Group II, non-brace group). Demographic data (age, sex, side of injury, time since injury), manual assessment (Lachman test, pivot shift test, ROM), PROs (IKDC score, Lysholm score) and Lachmeter examination were collected and analyzed at fixed time points during follow-up period as mean duration of follow up in our series was 18 months ± 3.4 (range, 12-24 months).

Official Title
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Objective Results of Anterior Cruciate Ligament Reconstruction With and Without Internal Suture Augmentation Technique

Conditions
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Anterior Cruciate Ligament Injuries

Intervention / Treatment
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* Procedure: all- inside anterior cruciate ligament reconstruction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 20-35 years old. Patients will be diagnosed as ACL tear by the following: I. History of knee traumatic event. II. Clinical examination (ant. Drawer test, Lachman test and pivot shift test). III. Radiological evidence of ACL tear by MRI. Exclusion Criteria: Other intra or extra articular knee injuries. Previous ACL surgery on the affected knee. Bilateral ACL injuries. Significant Articular surface injury. Medical comorbidities Patients with malalignment (genu varum. Genu valgum and Genu recurvatum) Neuromuscular disorders

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: anterior cruciate ligament reconstruction with internal suture augmentation technique<br>This group will be operated by using all-inside ACLR technique with internal suture augmentation technique | Procedure: all- inside anterior cruciate ligament reconstruction<br>* all- inside anterior cruciate ligament reconstruction with internal suture augmentation technique<br>|
| Active Comparator: anterior cruciate ligament reconstruction without internal suture augmentation technique<br>This group will be operated by using all-inside ACLR technique without internal suture augmentation technique | Procedure: all- inside anterior cruciate ligament reconstruction<br>* all- inside anterior cruciate ligament reconstruction with internal suture augmentation technique<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lachmeter examination | objective measurement of knee laxity | 9 months | 
| Lysholm score | subjective knee functional score (0 - 100) score. 100 is better in function | 9 months | 
| International Knee Documentation score (IKDC) score | subjective knee functional score (0 - 100) score. 100 is better in function | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| knee ROM | post- operative knee ROM | 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rolimeter, ACLR, internal suture augmentation, IKDC score, Lysholm score