Use of FlexHD as Post Trapeziectomy Spacer
- Conditions
- Osteoarthrosis of the Carpometacarpal Joint of the Thumb
- Interventions
- Procedure: Arthroplasty
- Registration Number
- NCT01998594
- Lead Sponsor
- Cedars-Sinai Medical Center
- Brief 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Arthroplasty with HADM Arthroplasty Twent-five (25) subjects with Eaton stage III-IV thumb CMC osteoarthritis undergo the 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 and quality of life questionnaires are compared to their preoperative scores. These subjects will be compared with a group of three - five (3 - 5) similar subjects who received the arthroplasty procedure without the use of the HADM spacer. Arthroplasty without HADM Arthroplasty Three - five (3 - 5) subjects with Eaton stage III-IV thumb CMC osteoarthritis undergo the basilar joint arthroplasty procedure without using a spacer constructed from human acellular matrix (HADM). Their postoperative DASH scores, grip strength, pinch strength, pain scale scores and quality of life questionnaires are compared to their preoperative scores. These subjects will be compared with a group of twenty-five (25) similar subjects who received the arthroplasty procedure with the use of the HADM spacer.
- Primary Outcome Measures
Name Time Method Functionality 12 months The objective of this study is to determine whether utilizing HADM will result in increased functionality measured by:
* DASH score
* Pinch and grip strength
* Pain scale
* Quality of life scores and
* Trapezial space on radiographs at designated intervals during the post-operative period
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Cedars-Sinai Department of Hand Surgery
🇺🇸Los Angeles, California, United States