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NCT Number: NCT05270551

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

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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Key information

Age range

15 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 -

Treatment and study plan

ACL reconstruction

Procedure

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

Primary outcomes

  1. Clinical outcome

    Time frame: 1 year follow up

    Tegner Lysholm scores, which assesses activity levels

  2. Clinical outcome

    Time frame: 1 year follow up

    International Knee Documentation Committee (IKDC) scores which assesses symptoms and function in daily living activities

Secondary outcomes

  1. Radiological outcome

    Time frame: 6 months follow up

    Magnetic resonance imaging (MRI) to assess graft healing, ACL tear and graft loosening

Study contacts

Contact information is provided by the study sponsor or research team.

Mohamed Abdel Tawab, Master

CONTACT

[email protected]

+201022141998

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Mar 8, 2022
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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