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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

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ClinicalTrials.gov Identifier: NCT04531826
Recruitment Status : Not yet recruiting
First Posted : August 31, 2020
Last Update Posted : August 31, 2020
Sponsor:
Information provided by (Responsible Party):
Keith Hay-Man Wan, Hospital Authority, Hong Kong

Study Description
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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.


Condition or disease Intervention/treatment Phase
Anterior Cruciate Ligament Injuries Other: 5-strand hamstring graft preparation Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Use of Five-strand Hamstring Autograft to Increase the Graft Size in Anterior Cruciate Ligament Reconstruction - a Prospective Randomized Controlled Trial
Estimated Study Start Date : January 1, 2021
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Group A
Five-strand hamstring autograft group
 Other: 5-strand hamstring graft preparation
Five-strand hamstring graft preparation
Placebo Comparator: Group B
Quadripled hamstring autograft group
 Other: 5-strand hamstring graft preparation
Five-strand hamstring graft preparation


Outcome Measures
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Primary Outcome Measures :
  1. Mean graft diameter [ Time Frame: Intra-operative ]

Secondary Outcome Measures :
  1. Adverse event [ Time Frame: Post-operative 3 months, 6 months, 9 months, 12 months, 18 months and 2 years. ]
    intra-operative complications, infections, venous thromboembolism

  2. ACL failure [ Time Frame: Post-operative 3 months, 6 months, 9 months, 12 months, 18 months and 2 years. ]
    Graft failure / re-rupture, ACL revision, contralateral ACL injury

  3. Clinical measures of knee function and structure [ Time Frame: Post-operative 3 months, 6 months, 9 months, 12 months, 18 months and 2 years. ]
    strength testing, hoop test, range of motion, knee osteoarthritis.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04531826


Contacts
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Contact: Keith Hay-Man Wan, FRCSEd (Orth) +852 35178089 keithayman@hotmail.com
Contact: Keith Hay-Man Wan, FRCSEd (Orth) +852 35178089

Sponsors and Collaborators
Hospital Authority, Hong Kong
More Information
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Responsible Party: Keith Hay-Man Wan, Associate Consultant, Hospital Authority, Hong Kong
ClinicalTrials.gov Identifier: NCT04531826    
Other Study ID Numbers: HAREC1
First Posted: August 31, 2020    Key Record Dates
Last Update Posted: August 31, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anterior Cruciate Ligament Injuries
Knee Injuries
Leg Injuries
Wounds and Injuries