The Use of Five-strand Hamstring Autograft to Increase the Graft Size in Anterior Cruciate Ligament Reconstruction - a Prospective Randomized Controlled Trial
1 other identifier
interventional
62
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2021
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 26, 2020
CompletedFirst Posted
Study publicly available on registry
August 31, 2020
CompletedStudy Start
First participant enrolled
January 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedAugust 31, 2020
August 1, 2020
2 years
August 26, 2020
August 26, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Mean graft diameter
Intra-operative
Secondary Outcomes (3)
Adverse event
Post-operative 3 months, 6 months, 9 months, 12 months, 18 months and 2 years.
ACL failure
Post-operative 3 months, 6 months, 9 months, 12 months, 18 months and 2 years.
Clinical measures of knee function and structure
Post-operative 3 months, 6 months, 9 months, 12 months, 18 months and 2 years.
Study Arms (2)
Group A
ACTIVE COMPARATORFive-strand hamstring autograft group
Group B
PLACEBO COMPARATORQuadripled hamstring autograft group
Interventions
Eligibility Criteria
You may qualify if:
- Age 18-50
- Symptoms and physical examinations consistent with ACL deficiency and magnetic resonance imaging indicating ACL injury
You may not qualify if:
- Previous surgeries in the operated knee
- Revision ACL reconstruction
- Contralateral ACL injury
- Concomitant posterior cruciate ligament / collateral ligament surgeries in the operated knee
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Consultant
Study Record Dates
First Submitted
August 26, 2020
First Posted
August 31, 2020
Study Start
January 1, 2021
Primary Completion
December 31, 2022
Study Completion
December 31, 2023
Last Updated
August 31, 2020
Record last verified: 2020-08