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

Phase 2

Completed

• Conditions: Anterior Cruciate Ligament Injuries
• Interventions: Procedure: all- inside anterior cruciate ligament reconstruction

• Registration Number: NCT04906538
• Lead Sponsor: Ain Shams University

Brief Summary

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

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).

Study Timeline

• Study Start: 2018-09-01
• Primary Completion: 2021-04-01
• Study Completion: 2021-04-01
• Status Verified: 2021-05
• Study First Submitted: 2021-05-25
• Study First Submitted QC: 2021-05-25
• Study First Posted: 2021-05-28
• Last Update Submitted: 2021-05-28
• Last Update Posted: 2021-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
anterior cruciate ligament reconstruction without internal suture augmentation technique	all- inside anterior cruciate ligament reconstruction	This group will be operated by using all-inside ACLR technique without internal suture augmentation technique
anterior cruciate ligament reconstruction with internal suture augmentation technique	all- inside anterior cruciate ligament reconstruction	This group will be operated by using all-inside ACLR technique with internal suture augmentation technique

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
knee ROM	9 months	post- operative knee ROM

Trial Locations

Locations (1)

Faculty of medicine; 🇪🇬 Cairo, Egypt