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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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04531826
Enrollment
62
Registered
2020-08-31
Start date
2021-01-01
Completion date
2023-12-31
Last updated
2020-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anterior Cruciate Ligament Injuries

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.

Interventions

OTHER5-strand hamstring graft preparation

Five-strand hamstring graft preparation

Sponsors

Hospital Authority, Hong Kong
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Mean graft diameterIntra-operative

Secondary

MeasureTime frameDescription
Adverse eventPost-operative 3 months, 6 months, 9 months, 12 months, 18 months and 2 years.intra-operative complications, infections, venous thromboembolism
ACL failurePost-operative 3 months, 6 months, 9 months, 12 months, 18 months and 2 years.Graft failure / re-rupture, ACL revision, contralateral ACL injury
Clinical measures of knee function and structurePost-operative 3 months, 6 months, 9 months, 12 months, 18 months and 2 years.strength testing, hoop test, range of motion, knee osteoarthritis.

Contacts

Primary ContactKeith Hay-Man Wan, FRCSEd (Orth)
keithayman@hotmail.com+852 35178089
Backup ContactKeith Hay-Man Wan, FRCSEd (Orth)
+852 35178089

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026