NCT04906538

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Ain Shams University · Academic / Other
• Sex: All
• Age: 20 Years – 35 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Anterior Cruciate Ligament Injuries

Interventions

Type	Name	Description
PROCEDURE	all- inside anterior cruciate ligament reconstruction	all- inside anterior cruciate ligament reconstruction with internal suture augmentation technique

Timeline

• Start date: 2018-09-01
• Primary completion: 2021-04-01
• Completion: 2021-04-01
• First posted: 2021-05-28
• Last updated: 2021-06-02

Locations

1 site across 1 country: Egypt