- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01724840
GraftJacket Versus Tendon Interposition for Trapeziometacarpal Osteoarthritis
Resection Suspension Arthroplasty With Interposition of GraftJacket Versus Tendon Interposition for Trapeziometacarpal Osteoarthritis: A Randomised Controlled Trial
Study Overview
Status
Intervention / Treatment
Detailed Description
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Zurich, Switzerland, 8008
- Schulthess Klinik
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion criteria:
- All adult patients diagnosed for TMC OA
- willing to participate and provide informed consent
Exclusion criteria:
- Patients with rheumatoid arthritis,
- pregnant women,
- legal incompetent patients,
- persons with insufficient knowledge of the German language to complete the questionnaires
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: GraftJacket
GraftJAcket is used as interpositional material
|
Interposition with GraftJacket
|
Active Comparator: Tendon Interposition
Flexor carpi radialis tendon is used as interpositional material
|
Tendon Interposition with the FCR tendon
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pain subscale of the Michigan Hand Questionnaire, 1 year following surgery
Time Frame: preOP, 6 weeks, 3, 6, and 12months post OP
|
preOP, 6 weeks, 3, 6, and 12months post OP
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
preOP, 6 weeks, 3, 6, and 12months post OP
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Costs, Treatment satisfaction, objective and subjective function
Time Frame: preOP, 6 weeks, 3, 6, and 12months post OP
|
preOP, 6 weeks, 3, 6, and 12months post OP
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Daniel B Herren, MD, MHA, Schulthess Klinik
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GraftJacket01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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