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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Anterior Cruciate Ligament Injuries

Intervention / Treatment
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* Other: 5-strand hamstring graft preparation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A<br>Five-strand hamstring autograft group | Other: 5-strand hamstring graft preparation<br>* Five-strand hamstring graft preparation<br>|
| Placebo Comparator: Group B<br>Quadripled hamstring autograft group | Other: 5-strand hamstring graft preparation<br>* Five-strand hamstring graft preparation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean graft diameter |  | Intra-operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse event | intra-operative complications, infections, venous thromboembolism | Post-operative 3 months, 6 months, 9 months, 12 months, 18 months and 2 years. | 
| ACL failure | Graft failure / re-rupture, ACL revision, contralateral ACL injury | Post-operative 3 months, 6 months, 9 months, 12 months, 18 months and 2 years. | 
| Clinical measures of knee function and structure | strength testing, hoop test, range of motion, knee osteoarthritis. | Post-operative 3 months, 6 months, 9 months, 12 months, 18 months and 2 years. |