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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-01

Study Completion Date

2023-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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ACL Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Group 1

Without augmentation

Group Type ACTIVE_COMPARATOR

ACL Reconstruction

Intervention Type PROCEDURE

All participants will do ACL reconstruction with and without Augmentation and will receive Accelerated rehabilitation program

Group 2

With augmentation

Group Type ACTIVE_COMPARATOR

ACL Reconstruction

Intervention Type PROCEDURE

All participants will do ACL reconstruction with and without Augmentation and will receive Accelerated rehabilitation program

Interventions

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ACL Reconstruction

All participants will do ACL reconstruction with and without Augmentation and will receive Accelerated rehabilitation program

Intervention Type PROCEDURE

Eligibility Criteria

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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 -

Minimum Eligible Age

15 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No