Use of FlexHD as Post Trapeziectomy Spacer

Use of FlexHD as a Post-Trapeziectomy Spacer in Patients Treated for Thumb Basal Joint Arthritis

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.

Subjects will be followed for 12 months post basilar joint arthroplasty procedure with an interposition arthroplasty technique using a spacer constructed from human acellular matrix (HADM). Their postoperative DASH scores, grip strength, pinch strength, pain scale scores, quality of life and trapezial space on radiographs are compared to their preoperative scores. Study visits will coincide with standard clinical course visits including: Pre-operative visits and follow-up visits at week 6, month 6, and year 1 post-operatively.

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