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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

NCT ID: NCT04531826

Last Updated: 2020-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2023-12-31

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.

Detailed Description

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Conditions

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Anterior Cruciate Ligament Injuries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Group A

Five-strand hamstring autograft group

Group Type ACTIVE_COMPARATOR

5-strand hamstring graft preparation

Intervention Type OTHER

Five-strand hamstring graft preparation

Group B

Quadripled hamstring autograft group

Group Type PLACEBO_COMPARATOR

5-strand hamstring graft preparation

Intervention Type OTHER

Five-strand hamstring graft preparation

Interventions

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5-strand hamstring graft preparation

Five-strand hamstring graft preparation

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Authority, Hong Kong

OTHER_GOV

Sponsor Role lead

Responsible Party

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Keith Hay-Man Wan

Associate Consultant

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Keith Hay-Man Wan, FRCSEd (Orth)

Role: CONTACT

Phone: +852 35178089

Email: [email protected]

Keith Hay-Man Wan, FRCSEd (Orth)

Role: CONTACT

Phone: +852 35178089

Other Identifiers

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HAREC1

Identifier Type: -

Identifier Source: org_study_id