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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Anterior Cruciate Ligament Injuries
• Intervention / Treatment: Other: 5-strand hamstring graft preparation

• Study Type: Interventional
• Enrollment (Anticipated): 62
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Keith Hay-Man Wan, FRCSEd (Orth); Phone Number: +852 35178089; Email: keithayman@hotmail.com
• Study Contact Backup: Name: Keith Hay-Man Wan, FRCSEd (Orth); Phone Number: +852 35178089

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Collaborators and Investigators

• Sponsor: Hospital Authority, Hong Kong

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2021
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: August 26, 2020
• First Submitted That Met QC Criteria: August 26, 2020
• First Posted (Actual): August 31, 2020

Study Record Updates

• Last Update Posted (Actual): August 31, 2020
• Last Update Submitted That Met QC Criteria: August 26, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Knee Injuries; Anterior Cruciate Ligament Injuries
• Other Study ID Numbers: HAREC1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No