Use of FlexHD as Post Trapeziectomy Spacer
Last updated on April 2022Recruitment
- Recruitment Status
- Completed
- Estimated Enrollment
- 60
Inclusion Criteria
- Basilar Joint Arthritis Eaton Stage III or IV
- Be willing to undergo thumb basilar joint arthroplasty with the use of acellular dermal matrix
- 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
- ...
- Basilar Joint Arthritis Eaton Stage III or IV
- Be willing to undergo thumb basilar joint arthroplasty with the use of acellular dermal matrix
- 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 realistic expectations of surgical results
- Be in good health other than the arthritis
- Male or Female >18 years of age
Exclusion Criteria
- Have collagen-vascular, connective tissue, or bleeding disorders
- Have regional sympathetic dystrophy
- Be a smoker or have smoked in last 2 months
- ...
- Have collagen-vascular, connective tissue, or bleeding disorders
- Have regional sympathetic dystrophy
- 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
- Be pregnant, lactating or expecting to be within the next 24 months
Summary
- Conditions
- Osteoarthrosis of the Carpometacarpal Joint of the Thumb
- Type
- Interventional
- Phase
- Phase 4
- Design
- Allocation: Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 trapezi...
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
- Basilar Joint Arthritis Eaton Stage III or IV
- Be willing to undergo thumb basilar joint arthroplasty with the use of acellular dermal matrix
- 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
- ...
- Basilar Joint Arthritis Eaton Stage III or IV
- Be willing to undergo thumb basilar joint arthroplasty with the use of acellular dermal matrix
- 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 realistic expectations of surgical results
- Be in good health other than the arthritis
- Male or Female >18 years of age
Exclusion Criteria
- Have collagen-vascular, connective tissue, or bleeding disorders
- Have regional sympathetic dystrophy
- Be a smoker or have smoked in last 2 months
- ...
- Have collagen-vascular, connective tissue, or bleeding disorders
- Have regional sympathetic dystrophy
- 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
- Be pregnant, lactating or expecting to be within the next 24 months
Tracking Information
- NCT #
- NCT01998594
- Collaborators
- Musculoskeletal Transplant Foundation
- Investigators
- Principal Investigator: David Kulber, MD Cedars-Sinai Medical Center
- David Kulber, MD Cedars-Sinai Medical Center