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临床试验/NCT04531826
NCT04531826Unknown不适用

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

Hospital Authority, Hong Kong0 个研究点目标入组 62 人开始时间: 2021年1月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
62
主要终点
Mean graft diameter

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18-50
  • Symptoms and physical examinations consistent with ACL deficiency and magnetic resonance imaging indicating ACL injury

排除标准

  • Previous surgeries in the operated knee
  • Revision ACL reconstruction
  • Contralateral ACL injury
  • Concomitant posterior cruciate ligament / collateral ligament surgeries in the operated knee

结局指标

主要结局

Mean graft diameter

时间窗: Intra-operative

次要结局

  • Clinical measures of knee function and structure(Post-operative 3 months, 6 months, 9 months, 12 months, 18 months and 2 years.)
  • ACL failure(Post-operative 3 months, 6 months, 9 months, 12 months, 18 months and 2 years.)
  • Adverse event(Post-operative 3 months, 6 months, 9 months, 12 months, 18 months and 2 years.)

研究者

发起方
Hospital Authority, Hong Kong
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Keith Hay-Man Wan

Associate Consultant

Hospital Authority, Hong Kong

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