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

April 28, 2026 updated by: Mohamed Abdel-Tawab, Assiut University
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

114

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 50 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group 1
Without augmentation
Procedure: ACL Reconstruction
All participants will do ACL reconstruction with and without Augmentation and will receive Accelerated rehabilitation program
Active Comparator: Group 2
With augmentation
Procedure: ACL Reconstruction
All participants will do ACL reconstruction with and without Augmentation and will receive Accelerated rehabilitation program

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical outcome
Time Frame: 1 year follow up
Tegner Lysholm scores, which assesses activity levels
1 year follow up
Clinical outcome
Time Frame: 1 year follow up
International Knee Documentation Committee (IKDC) scores which assesses symptoms and function in daily living activities
1 year follow up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiological outcome
Time Frame: 6 months follow up
Magnetic resonance imaging (MRI) to assess graft healing, ACL tear and graft loosening
6 months follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Chair: Mohamed Abdel Hamid, Professor, Mohamad Mohamed Abdel-Hamid Morsy
  • Principal Investigator: Hatem Galal El-Din Zaki, Professor, Hatem Galal El-Din Zaki
  • Study Director: Mohamed Abd El-Radi, Lecturer, Mohamed Abd El-Radi Abd El-Salam

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

February 14, 2022

First Submitted That Met QC Criteria

February 27, 2022

First Posted (Actual)

March 8, 2022

Study Record Updates

Last Update Posted (Actual)

April 30, 2026

Last Update Submitted That Met QC Criteria

April 28, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACL Recon. rehabilitation

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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