Study Stopped
Due to lack of enrollment, challenging follow-up, and lack of funding.
Single Blinded First CMC Osteoarthritis Treatment
Randomized Single Blinded First CMC Osteoarthritis Treatment: Therapy and Bracing Alone vs. Intra-Articular Corticosteroid Injection vs Intra-Articular Leukocyte Depleted Platelet Rich Plasma
1 other identifier
interventional
74
1 country
1
Brief Summary
Single blinded PRP vs. Corticosteroid vs. Placebo (normal saline) intra-articular injection for basal joint arthritis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 21, 2017
CompletedFirst Posted
Study publicly available on registry
June 22, 2017
CompletedStudy Start
First participant enrolled
September 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2025
CompletedApril 8, 2026
April 1, 2026
6.6 years
June 21, 2017
April 2, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Disabilities arm shoulder and hand score
functional score
1 year
Secondary Outcomes (1)
Pinch Strength
1 year
Other Outcomes (1)
Visual Analog Score
1 year
Study Arms (3)
PRP
EXPERIMENTALIntra-articular injection of platelet rich plasma.
Corticosteroid
ACTIVE COMPARATORIntra-articular injection of kenalog.
Normal Saline
PLACEBO COMPARATORIntra-articular injection of normal saline
Interventions
Eligibility Criteria
You may qualify if:
- Stage 1-3 osteoarthritis of the basal joint
You may not qualify if:
- Patients with Stage 4 1st carpometacarpal joint arthritis as described by Eaton
- Patients who have received a corticosteroid injection in the last year to the 1st CMC joint on the proposed study side
- Patients who have scaphotriquetral, radioscaphoid, or scaphotrapezial osteoarthritis
- Patients who have concurrent DeQuervain's tenosynovitis or intersection syndrome or have been treated for either of these in the last 3 months
- Patients undergoing evaluation of cervical radiculopathy
- Patients with fibromyalgia or inflammatory rheumatic disease
- Patients with Pressier disease, Kienbock's, or avascular necrosis of the scaphoid
- Patients with any history of primary or secondary bone tumor
- Patients that are pregnant or terminally ill
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Orthopedic Associates of Southwest Ohio
Centerville, Ohio, 45459, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Patients will be blinded to therapy they receive
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 21, 2017
First Posted
June 22, 2017
Study Start
September 1, 2018
Primary Completion
March 31, 2025
Study Completion
March 31, 2025
Last Updated
April 8, 2026
Record last verified: 2026-04