Clinical trial NCT04531826: The Use of Five-strand Hamstring Autograft to Increase the Graft Size in Anterior Cruciate Ligament Reconstruction - a Prospective Randomized Controlled Trial
Official title: The Use of Five-strand Hamstring Autograft to Increase the Graft Size in Anterior Cruciate Ligament Reconstruction - a Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anterior Cruciate Ligament Injuries
Lead sponsor: Hospital Authority, Hong Kong
Sponsor class: OTHER_GOV
First posted: 2020-08-31
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Mean graft diameter
timeFrame: Intra-operative
Secondary outcomes:
measure: Adverse event
timeFrame: Post-operative 3 months, 6 months, 9 months, 12 months, 18 months and 2 years.
measure: ACL failure
timeFrame: Post-operative 3 months, 6 months, 9 months, 12 months, 18 months and 2 years.
measure: Clinical measures of knee function and structure
timeFrame: Post-operative 3 months, 6 months, 9 months, 12 months, 18 months and 2 years.
Other outcomes:
Locations:
Study officials:
References: