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
About this trial
This is an interventional treatment trial for Anterior Cruciate Ligament Injuries
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
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
NCT ID
NCT04531826
First Posted
August 26, 2020
Last Updated
August 26, 2020
Sponsor
Hospital Authority, Hong Kong
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
We'll reach out to this number within 24 hrs