Recruitment

Recruitment Status
Completed
Estimated Enrollment
60

Inclusion Criterias

Be in good health other than the arthritis
Be willing to undergo thumb basilar joint arthroplasty with the use of acellular dermal matrix
Have realistic expectations of surgical results
...
Be in good health other than the arthritis
Be willing to undergo thumb basilar joint arthroplasty with the use of acellular dermal matrix
Have realistic expectations of surgical results
Male or Female >18 years of age
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

Exclusion Criterias

Have collagen-vascular, connective tissue, or bleeding disorders
Have any disease, including uncontrolled diabetes, which is clinically known to impact wound healing ability
Have regional sympathetic dystrophy
...
Have collagen-vascular, connective tissue, or bleeding disorders
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
Be a smoker or have smoked in last 2 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 Criterias

Be in good health other than the arthritis
Be willing to undergo thumb basilar joint arthroplasty with the use of acellular dermal matrix
Have realistic expectations of surgical results
...
Be in good health other than the arthritis
Be willing to undergo thumb basilar joint arthroplasty with the use of acellular dermal matrix
Have realistic expectations of surgical results
Male or Female >18 years of age
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

Exclusion Criterias

Have collagen-vascular, connective tissue, or bleeding disorders
Have any disease, including uncontrolled diabetes, which is clinically known to impact wound healing ability
Have regional sympathetic dystrophy
...
Have collagen-vascular, connective tissue, or bleeding disorders
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
Be a smoker or have smoked in last 2 months

Locations

Los Angeles, California, 90048
Los Angeles, California, 90048

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