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The Use of Five-strand Hamstring Autograft to Increase the Graft Size in Anterior Cruciate Ligament Reconstruction - a Prospective Randomized Controlled Trial

Primary Purpose

Anterior Cruciate Ligament Injuries

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
5-strand hamstring graft preparation
Sponsored by
Hospital Authority, Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anterior Cruciate Ligament Injuries

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 18-50
  • Symptoms and physical examinations consistent with ACL deficiency and magnetic resonance imaging indicating ACL injury

Exclusion Criteria:

  • Previous surgeries in the operated knee
  • Revision ACL reconstruction
  • Contralateral ACL injury
  • Concomitant posterior cruciate ligament / collateral ligament surgeries in the operated knee

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Group A

    Group B

    Arm Description

    Five-strand hamstring autograft group

    Quadripled hamstring autograft group

    Outcomes

    Primary Outcome Measures

    Mean graft diameter

    Secondary Outcome Measures

    Adverse event
    intra-operative complications, infections, venous thromboembolism
    ACL failure
    Graft failure / re-rupture, ACL revision, contralateral ACL injury
    Clinical measures of knee function and structure
    strength testing, hoop test, range of motion, knee osteoarthritis.

    Full Information

    First Posted
    August 26, 2020
    Last Updated
    August 26, 2020
    Sponsor
    Hospital Authority, Hong Kong
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04531826
    Brief Title
    The Use of Five-strand Hamstring Autograft to Increase the Graft Size in Anterior Cruciate Ligament Reconstruction - a Prospective Randomized Controlled Trial
    Official Title
    The Use of Five-strand Hamstring Autograft to Increase the Graft Size in Anterior Cruciate Ligament Reconstruction - a Prospective Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2020
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 1, 2021 (Anticipated)
    Primary Completion Date
    December 31, 2022 (Anticipated)
    Study Completion Date
    December 31, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hospital Authority, Hong Kong

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Anterior cruciate ligament (ACL) reconstruction is one of most commonly performed orthopaedic surgeries. Several options for graft choice are available and autologous single bundle hamstring graft is most commonly used. Variability exists among patients in terms of hamstring size, and therefore the graft diameter. Recently there has been an increasing amount of literature correlating the hamstring graft diameter with the graft failure rate [1-4]. They concluded that graft exceeding 8mm in diameter is associated with a significant lower risk of graft failure. There has been study showing that Asian patients were indeed 'different' from the Caucasians. Ho et al published his findings on Singaporean patients showing that the median graft diameters for female and male patients were 7mm and 8mm respectively [5]. A retrospective review our patients undergoing ACL reconstruction in our department over the past 10 years has shown that the mean graft diameter was 7.8mm (range, 5.5-10mm). The conventional way of four-strand hamstring autograft is done by doubling both the semitendinosus and gracilis tendons to provide a quadrupled graft. Several techniques have been described to increase the size of the hamstring graft. One of those is the -strand hamstring graft, in which the longer semitendinosus tendon is tripled with the shorter gracilis tendon doubled to produce a 5-strand configuration. We hypothesized that the 5-strand hamstring graft would provide a graft of significantly larger diameter than the conventional quadrupled autograft.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anterior Cruciate Ligament Injuries

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    62 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group A
    Arm Type
    Active Comparator
    Arm Description
    Five-strand hamstring autograft group
    Arm Title
    Group B
    Arm Type
    Placebo Comparator
    Arm Description
    Quadripled hamstring autograft group
    Intervention Type
    Other
    Intervention Name(s)
    5-strand hamstring graft preparation
    Intervention Description
    Five-strand hamstring graft preparation
    Primary Outcome Measure Information:
    Title
    Mean graft diameter
    Time Frame
    Intra-operative
    Secondary Outcome Measure Information:
    Title
    Adverse event
    Description
    intra-operative complications, infections, venous thromboembolism
    Time Frame
    Post-operative 3 months, 6 months, 9 months, 12 months, 18 months and 2 years.
    Title
    ACL failure
    Description
    Graft failure / re-rupture, ACL revision, contralateral ACL injury
    Time Frame
    Post-operative 3 months, 6 months, 9 months, 12 months, 18 months and 2 years.
    Title
    Clinical measures of knee function and structure
    Description
    strength testing, hoop test, range of motion, knee osteoarthritis.
    Time Frame
    Post-operative 3 months, 6 months, 9 months, 12 months, 18 months and 2 years.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age 18-50 Symptoms and physical examinations consistent with ACL deficiency and magnetic resonance imaging indicating ACL injury Exclusion Criteria: Previous surgeries in the operated knee Revision ACL reconstruction Contralateral ACL injury Concomitant posterior cruciate ligament / collateral ligament surgeries in the operated knee
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Keith Hay-Man Wan, FRCSEd (Orth)
    Phone
    +852 35178089
    Email
    keithayman@hotmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Keith Hay-Man Wan, FRCSEd (Orth)
    Phone
    +852 35178089

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    The Use of Five-strand Hamstring Autograft to Increase the Graft Size in Anterior Cruciate Ligament Reconstruction - a Prospective Randomized Controlled Trial

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