GraftJacket Versus Tendon Interposition for Trapeziometacarpal Osteoarthritis
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|ClinicalTrials.gov Identifier: NCT01724840|
Recruitment Status : Completed
First Posted : November 12, 2012
Last Update Posted : August 22, 2016
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthrosis of the Carpometacarpal Joint of the Thumb||Procedure: GraftJacket Procedure: Tendon Interposition||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Resection Suspension Arthroplasty With Interposition of GraftJacket Versus Tendon Interposition for Trapeziometacarpal Osteoarthritis: A Randomised Controlled Trial|
|Study Start Date :||September 2012|
|Actual Primary Completion Date :||April 2015|
|Actual Study Completion Date :||April 2015|
GraftJAcket is used as interpositional material
Interposition with GraftJacket
Active Comparator: Tendon Interposition
Flexor carpi radialis tendon is used as interpositional material
Procedure: Tendon Interposition
Tendon Interposition with the FCR tendon
- Pain subscale of the Michigan Hand Questionnaire, 1 year following surgery [ Time Frame: preOP, 6 weeks, 3, 6, and 12months post OP ]
- Secondary objectives are the comparison of the complications associated with the different surgical procedures as well as a cost-utility analysis. [ Time Frame: preOP, 6 weeks, 3, 6, and 12months post OP ]
- Costs, Treatment satisfaction, objective and subjective function [ Time Frame: preOP, 6 weeks, 3, 6, and 12months post OP ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01724840
|Zurich, Switzerland, 8008|
|Principal Investigator:||Daniel B Herren, MD, MHA||Schulthess Klinik|