Status:
ENROLLING_BY_INVITATION
Efficacy of a Single Injection of CTM for Post-Operative CMC Arthritis
Lead Sponsor:
Indiana Hand to Shoulder Center
Collaborating Sponsors:
CTM Biomedical
Conditions:
Osteoarthritis
Osteoarthritis Thumb Base Joint
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The goal of this study is to determine the success rate of a single Carpometacarpal (CMC) thumb injection after arthroplasty surgery for primary osteoarthritis of the CMC joint.
Detailed Description
CTM Biomedical markets and distributes decellularized particulate human placental connective-tissue matrix products, intended solely for homologous use to supplement or replace damaged or inadequate c...
Eligibility Criteria
Inclusion
- Males or females age 18 or older
- Patients presenting for basilar thumb reconstruction surgery (any surgical technique)
- Patients who can consent to be a part of this study
- Patients who are able to return to the Indiana Hand to Shoulder Center or satellite location for follow up time points
Exclusion
- Additional procedures at the same time
- Patients with previous basilar thumb reconstruction on the operative side (revision surgery)
- Chronic narcotic use
- Women who are pregnancy or breastfeeding
- Non-English speaking
Key Trial Info
Start Date :
March 7 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06171529
Start Date
March 7 2023
End Date
January 31 2026
Last Update
March 28 2024
Active Locations (1)
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1
Indiana Hand to Shoulder Center
Indianapolis, Indiana, United States, 46260