The Effect of Accelerated Rehabilitation After Anterior Cruciate Ligament Reconstruction With and Without Suture Tape Reinforcement
Primary Purpose
ACL Injury
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ACL Reconstruction
Sponsored by
About this trial
This is an interventional prevention trial for ACL Injury focused on measuring Rehabilitation
Eligibility Criteria
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 -
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group 1
Group 2
Arm Description
Without augmentation
With augmentation
Outcomes
Primary Outcome Measures
Clinical outcome
Tegner Lysholm scores, which assesses activity levels
Clinical outcome
International Knee Documentation Committee (IKDC) scores which assesses symptoms and function in daily living activities
Secondary Outcome Measures
Radiological outcome
Magnetic resonance imaging (MRI) to assess graft healing, ACL tear and graft loosening
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05270551
Brief Title
The Effect of Accelerated Rehabilitation After Anterior Cruciate Ligament Reconstruction With and Without Suture Tape Reinforcement
Official Title
The Effect of Accelerated Rehabilitation After Anterior Cruciate Ligament Reconstruction With and Without Suture Tape Reinforcement
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 1, 2022 (Anticipated)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
May 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ACL Injury
Keywords
Rehabilitation
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
114 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
Without augmentation
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
With augmentation
Intervention Type
Procedure
Intervention Name(s)
ACL Reconstruction
Intervention Description
All participants will do ACL reconstruction with and without Augmentation and will receive Accelerated rehabilitation program
Primary Outcome Measure Information:
Title
Clinical outcome
Description
Tegner Lysholm scores, which assesses activity levels
Time Frame
1 year follow up
Title
Clinical outcome
Description
International Knee Documentation Committee (IKDC) scores which assesses symptoms and function in daily living activities
Time Frame
1 year follow up
Secondary Outcome Measure Information:
Title
Radiological outcome
Description
Magnetic resonance imaging (MRI) to assess graft healing, ACL tear and graft loosening
Time Frame
6 months follow up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed Abdel Tawab, Master
Phone
+201022141998
Email
mohamedtawab8892@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed Abdel Hamid, Professor
Organizational Affiliation
Mohamad Mohamed Abdel-Hamid Morsy
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Hatem Galal El-Din Zaki, Professor
Organizational Affiliation
Hatem Galal El-Din Zaki
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mohamed Abd El-Radi, Lecturer
Organizational Affiliation
Mohamed Abd El-Radi Abd El-Salam
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
26410092
Citation
Schlumberger M, Schuster P, Schulz M, Immendorfer M, Mayer P, Bartholoma 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.
Results Reference
background
PubMed Identifier
30945237
Citation
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.
Results Reference
background
PubMed Identifier
33128587
Citation
Cristiani R, Mikkelsen C, Wange P, Olsson D, Stalman A, Engstrom 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.
Results Reference
background
PubMed Identifier
28224069
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.
Results Reference
background
PubMed Identifier
19047767
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.
Results Reference
background
PubMed Identifier
16230470
Citation
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. doi: 10.1177/0363546505279922.
Results Reference
background
Citation
Dean AG. OpenEpi: open source epidemiologic statistics for public health, version 2.3. 1. http://www. openepi. com. 2010.
Results Reference
background
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The Effect of Accelerated Rehabilitation After Anterior Cruciate Ligament Reconstruction With and Without Suture Tape Reinforcement
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