The Effect of Accelerated Rehabilitation After Anterior Cruciate Ligament Reconstruction With and Without Suture Tape Reinforcement

Not Applicable

• Conditions: ACL Injury
• Interventions: Procedure: ACL Reconstruction

• Registration Number: NCT05270551
• Lead Sponsor: Assiut University

Brief Summary

The aim of our study is to evaluate the effect of accelerated rehabilitation post ACL reconstruction with and without augmentation on graft healing and return to normal activity clinically by scoring system and radiologically.

Detailed Description

ACL reconstruction is the most commonly performed knee ligament reconstruction and employs a variety of surgical techniques. However, despite high success rates, it is still challenged by residual laxity and graft rupture.

While the majority of patients who undergo ACLR will have good to excellent results, a subset of patients is at a higher risk for graft failure. For those that require revision surgery, the second operation often fails. Anterior cruciate ligament injuries account for 50% of knee ligament injuries for high school-aged adults.

The most commonly used autografts for ACLR are the hamstring tendons (HT) and the bone-patellar tendon-bone (BPTB). However, questions remain about how patients with either an HT or a BPTB autograft recover knee muscle strength postoperatively.

To help address and prevent future ACL failures, new repair and reconstruction techniques have been employed that incorporate suture augmentation. The goal of augmentation is to protect the newly repaired or reconstructed ligament during rehabilitation.

Despite advances in anterior cruciate ligament (ACL) reconstruction surgical techniques and rehabilitation, recent studies report that between 20% to 50% of those with ACL reconstruction do not return to the same sports after surgery and 10% to 70% of those who resume preinjury sports participate at a reduced level or with significant functional impairments.

Anecdotal evidence from patient report and clinical observation suggests that an inability to return to sports after ACL reconstruction can be partially attributed to a fear of reinjuring the knee.

Study Timeline

• Status Verified: 2022-02
• Study First Submitted: 2022-02-14
• Study First Submitted QC: 2022-02-27
• Last Update Submitted: 2022-02-27
• Study Start: 2022-03-01
• Study First Posted: 2022-03-08
• Last Update Posted: 2022-03-08
• Primary Completion: 2023-03
• Study Completion: 2023-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 114

Inclusion Criteria

• Age from 15 to 50 years old.
• With or without meniscal injury.
• Isolated ACL injury without any other ligament injury.
• Recent and chronic injury.

Exclusion Criteria

• Multiligament injury.
• Deformed knee (Genu varus or valgus).
• Previous ACL reconstruction or repair.
• Older than 50 years old and younger than 15 years old.
• Failed ACL reconstruction or repair -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	ACL Reconstruction	Without augmentation
Group 2	ACL Reconstruction	With augmentation

Primary Outcome Measures

Name	Time	Method
Clinical outcome	1 year follow up	International Knee Documentation Committee (IKDC) scores which assesses symptoms and function in daily living activities

Secondary Outcome Measures

Name	Time	Method
Radiological outcome	6 months follow up	Magnetic resonance imaging (MRI) to assess graft healing, ACL tear and graft loosening