Use of FlexHD as Post Trapeziectomy Spacer

Completed · Phase 4

Conditions studied: Osteoarthrosis of the Carpometacarpal Joint of the Thumb

In brief

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.

Key facts

Study ID

NCT01998594

Run by

Cedars-Sinai Medical Center

People needed

30

Starts

2013-08-01

Expected to finish

2017-12-01

Last updated by the study team

2019-01-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Cedars-Sinai Department of Hand Surgery — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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