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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
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for ACL Injury focused on measuring Rehabilitation

Eligibility Criteria

15 Years - 50 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    February 14, 2022
    Last Updated
    February 27, 2022
    Sponsor
    Assiut University
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    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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