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

Ain Shams University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Anterior Cruciate Ligament Injuries

Treatments: Procedure: all- inside anterior cruciate ligament reconstruction

Study type: Interventional

Funder types: Other

Identifiers

NCT04906538

FMASU MD 310 2018

Details and patient eligibility

About

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.

Full 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).

Enrollment: 38 patients

Sex: All

Ages: 20 to 35 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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38 participants in 2 patient groups

anterior cruciate ligament reconstruction with internal suture augmentation technique

Active Comparator group

Description:

This group will be operated by using all-inside ACLR technique with internal suture augmentation technique

Treatment:

Procedure: all- inside anterior cruciate ligament reconstruction

anterior cruciate ligament reconstruction without internal suture augmentation technique

Active Comparator group

Description:

This group will be operated by using all-inside ACLR technique without internal suture augmentation technique

Treatment:

Procedure: all- inside anterior cruciate ligament reconstruction