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临床试验/NCT01724840
NCT01724840已完成不适用

Resection Suspension Arthroplasty With Interposition of GraftJacket Versus Tendon Interposition for Trapeziometacarpal Osteoarthritis: A Randomised Controlled Trial

Schulthess Klinik2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2012年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
Pain subscale of the Michigan Hand Questionnaire, 1 year following surgery

研究概览

简要总结

Studies at the shoulder, Achilles tendon and thumb show satisfactory results regarding the use of GaftJacket. Initial trials at the thumb show, that the GraftJacket can be safely and successfully used in TMC OA surgery and therefore represents an acceptable alternative for avoiding possible donor-site morbidity. However, there are no randomised controlled trials (RCT) in which the outcomes of using a tendon interposition or the GraftJacket are compared. Only with an RCT design it is possible to gain evidence about the advantages of one treatment method over another. The main objective of the study is the comparison between two surgical techniques for TMC OA: The resection interposition suspension arthroplasty using a part of the flexor carpi radialis tendon as interpositional material and using the GraftJacket as interpositional material.

详细描述

Besides the use of the flexor carpi radialis tendon, several materials can serve as the interposition tissue including Gore-Tex, silicone and other types of metal or polymer implants. The use of Gore-Tex, silicone and metal implants, have been shown to carry high complication rates secondary to synovitis and mechanical failure combined with poor patient outcomes. A study about a porcine collagen xenograft was terminated prematurely because of poor outcomes and adverse immunologic reactions.

Another option is using allograft, which is dermal or tendon tissue from another human donor such as the GraftJacket (Wright Medical Technology, Inc., Arlington, TN). This product is manufactured from donated cadaveric tissue that is treated to remove all cellular components while preserving the native collagen scaffold. It thus provides the strength and integrity of native autograft without the adverse immunologic response of traditional allograft. It is in compliance with the American Association of Tissue Banks guidelines for allograft material, and it is classified as human tissue for transplantation.

The GraftJacket shows high biocompatibility and the advantages compared to autograft are avoiding donor site morbidity as well as decreased surgical time.

GraftJacket has mainly being used for the repair of rotator cuff tears and Achilles tendons ruptures. No complications have been reported and patients showed significant improved outcomes compared with their preoperative conditions. Although all of the studies show methodological limitations due to the lack of a control group, these results show a great potential and warrant further investigations.

In contrast to the studies already conducted in the Achilles tendon and shoulder joint, there are only sparse data concerning other joints of the upper extremity such as the elbow and the hand. Treating TMC OA of Eaton stage ll, lll and lV with GraftJacket has only been reported in two studies. The patients under investigation reported significant pain relief, significant improvements regarding grip and key pinch strength, good ability to perform activities of daily living (ADL) and high satisfaction rates. No or only minimal postoperative complications such as paraesthesia which are not directly related to the GraftJacket have been reported. However, some limitations of these two studies have to be acknowledges. Both are observational studies without control group making it impossible to conclude if this approach is favourable compared to standard techniques.

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
None

入排标准

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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Pain subscale of the Michigan Hand Questionnaire, 1 year following surgery

时间窗: preOP, 6 weeks, 3, 6, and 12months post OP

次要结局

  • Secondary objectives are the comparison of the complications associated with the different surgical procedures as well as a cost-utility analysis.(preOP, 6 weeks, 3, 6, and 12months post OP)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Daniel Herren

MD, MHA

Schulthess Klinik

研究点 (2)

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