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临床试验/NCT01727739
NCT01727739已完成不适用

Tibial Tunnel Widening in ACL Reconstruction-Comparing Two Bioscrews: A Prospective Randomized Clinical Trial

Panam Clinic2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2012年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
80
试验地点
2
主要终点
Radiographs

研究概览

简要总结

Widening of the single tibial tunnel following ACL surgery with quadrupled hamstrings autograft may contribute to failure of the graft and/or present technical challenges secondary to bone loss in a revision setting (Getelman, 1999). As such, efforts should be made to minimize the incidence and magnitude of tibial tunnel widening without sacrificing the biomechanical properties of the graft construct. The purpose of this investigation is to examine the tibial tunnel widening relationship between bioabsorbable interference screws composed of poly-L-lactic acid (PLLA) alone and composite bioabsorbable interference screws composed of poly-L-lactic acid embedded with beta tricalcium phosphate (PLLA+TCP) utilized as tibial fixation devices.

Specifically the study has the following objectives: 1) To quantify the extent of tibial tunnel enlargement at 3-, 6- and 12-months post ACL reconstruction with autogenous quadrupled hamstring graft; 2) To determine if the incorporation of beta tricalcium phosphate to the bioabsorbable interference screw alters the observed magnitude of tunnel widening; 3) To hypothesize mechanisms for any observed differences between tibial fixation devices; and 4) To correlate tibial tunnel widening with clinical outcome status. It is hypothesized that the PLLA+TCP bioabsorbable interference screw will not be associated with a reduction in tibial tunnel widening around the implant but rather between the implant and articular surface, compared to the PLLA alone screw. It is also hypothesized that there will be no effect of observed tunnel widening on clinical outcomes or graft failure rates.

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 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Must have a unilateral ACL rupture
  • Patients must be between 18 and 45 years old

排除标准

  • Concomitant medial collateral, lateral collateral, or posterior collateral ligament tears
  • Severe chondromalacia or severe meniscal tear
  • Previous history of ipsilateral knee joint pathology, surgery, or trauma to that knee
  • Unwillingness to be followed for 12 months post-operatively
  • History of arthritis (osteoarthritis or rheumatoid)
  • Pregnancy
  • Psychiatric illness that precludes informed consent
  • Unable to speak or read English/French
  • Major medical illness (life expectancy less than 1 year or unacceptably high operative risk)

研究组 & 干预措施

PLLA bioscrew

Active Comparator

poly-L-lactic acid bioscrew

干预措施: Linvatec PLLA (Device)

PLLA+TCP bioscrew

Active Comparator

poly-l-lactic acid with beta tricalcium phosphate bioscrew

干预措施: Linvatec PLLA+TCP (Device)

结局指标

主要结局

Radiographs

时间窗: 12 months post op

At 3-, 6- and 12-months post-operatively, subjects will undergo radiographic examination of their affected knee (standardized AP and lateral views) for analysis of tibial tunnel parameters. Radiographic analysis will be conducted by a single orthopaedic surgeon/fellow/resident blinded to subject group and clinical examination results. Parameters to be recorded and analyzed according to a standardized method: tibial tunnel diameter (max/min). We will also look for: Evidence of lysis in the tunnel and changes in morphological features of tunnel over time

次要结局

  • ACL Quality of Life Scores(12 months post op)

研究者

发起方
Panam Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Peter MacDonald

Research Associate

Panam Clinic

研究点 (2)

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