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

ACL Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05270551
• Other study ID #: ACL Recon. rehabilitation
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: May 2023

Study information

• Verified date: February 2022
• Source: Assiut University
• Contact: Mohamed Abdel Tawab, Master
• Phone: +201022141998
• Email: mohamedtawab8892[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 114
• Est. completion date: May 2023
• Est. primary completion date: March 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 50 Years

Eligibility

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 -

Related Conditions & MeSH terms

• ACL Injury
• Anterior Cruciate Ligament Injuries

Intervention

Procedure:
• ACL Reconstruction
All participants will do ACL reconstruction with and without Augmentation and will receive Accelerated rehabilitation program

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (7)

Beynnon BD, Johnson RJ, Abate JA, Fleming BC, Nichols CE. Treatment of anterior cruciate ligament injuries, part 2. Am J Sports Med. 2005 Nov;33(11):1751-67. Review. — View Citation

Chmielewski TL, Jones D, Day T, Tillman SM, Lentz TA, George SZ. The association of pain and fear of movement/reinjury with function during anterior cruciate ligament reconstruction rehabilitation. J Orthop Sports Phys Ther. 2008 Dec;38(12):746-53. doi: 10.2519/jospt.2008.2887. — View Citation

Cristiani R, Mikkelsen C, Wange P, Olsson D, Stålman A, Engström B. Autograft type affects muscle strength and hop performance after ACL reconstruction. A randomised controlled trial comparing patellar tendon and hamstring tendon autografts with standard or accelerated rehabilitation. Knee Surg Sports Traumatol Arthrosc. 2021 Sep;29(9):3025-3036. doi: 10.1007/s00167-020-06334-5. Epub 2020 Oct 31. — View Citation

Dean AG. OpenEpi: open source epidemiologic statistics for public health, version 2.3. 1. http://www. openepi. com. 2010.

Riediger MD, Stride D, Coke SE, Kurz AZ, Duong A, Ayeni OR. ACL Reconstruction with Augmentation: a Scoping Review. Curr Rev Musculoskelet Med. 2019 Jun;12(2):166-172. doi: 10.1007/s12178-019-09548-4. Review. — View Citation

Schlumberger M, Schuster P, Schulz M, Immendörfer M, Mayer P, Bartholomä J, Richter J. Traumatic graft rupture after primary and revision anterior cruciate ligament reconstruction: retrospective analysis of incidence and risk factors in 2915 cases. Knee Surg Sports Traumatol Arthrosc. 2017 May;25(5):1535-1541. doi: 10.1007/s00167-015-3699-0. Epub 2015 Sep 26. — View Citation

Smith PA, Bley JA. Allograft Anterior Cruciate Ligament Reconstruction Utilizing Internal Brace Augmentation. Arthrosc Tech. 2016 Oct 10;5(5):e1143-e1147. doi: 10.1016/j.eats.2016.06.007. eCollection 2016 Oct. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical outcome	Tegner Lysholm scores, which assesses activity levels	1 year follow up
Primary	Clinical outcome	International Knee Documentation Committee (IKDC) scores which assesses symptoms and function in daily living activities	1 year follow up
Secondary	Radiological outcome	Magnetic resonance imaging (MRI) to assess graft healing, ACL tear and graft loosening	6 months follow up