Use of FlexHD as Post Trapeziectomy Spacer (NCT01998594) | Clinical Trial Compass
CompletedPhase 4
Use of FlexHD as Post Trapeziectomy Spacer
United States30 participantsStarted 2013-08
Plain-language summary
The objective of this study is to show that using FlexHD® (or HADM) to fill the empty space created by removal of the trapezium improves the subject's outcome and subsequent functionality of the basilar joint arthroplasty procedure.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male or Female \>18 years of age
* Be willing to undergo thumb basilar joint arthroplasty with the use of acellular dermal matrix
* Basilar Joint Arthritis Eaton Stage III or IV
* Be in good health other than the arthritis
* Have realistic expectations of surgical results
* Understand and be willing to follow all aspects of the study protocol and have signed and dated the IRB-approved Informed Consent Form and the Authorization for Use and Release of Health and Research Study Information (HIPAA) form prior to any study-related procedures being performed
Exclusion Criteria:
* Have collagen-vascular, connective tissue, or bleeding disorders
* Be a smoker or have smoked in last 2 months
* Have any disease, including uncontrolled diabetes, which is clinically known to impact wound healing ability
* Have regional sympathetic dystrophy
* Be pregnant, lactating or expecting to be within the next 24 months