Osteoarthrosis of the Carpometacarpal Joint of the Thumb Clinical Trial
Official title:
Resection Suspension Arthroplasty With Interposition of GraftJacket Versus Tendon Interposition for Trapeziometacarpal Osteoarthritis: A Randomised Controlled Trial
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.
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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