Back to resultsSingle Blinded First CMC Osteoarthritis Treatment
Primary Purpose
Osteoarthritis Thumb
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Platelet Concentrate
Corticosteroid injection
Normal Saline
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis Thumb
Eligibility Criteria
Inclusion Criteria:
- Stage 1-3 osteoarthritis of the basal joint
Exclusion Criteria:
- 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
Sites / Locations
- Orthopedic Associates of Southwest OhioRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
PRP
Corticosteroid
Normal Saline
Arm Description
Intra-articular injection of platelet rich plasma.
Intra-articular injection of kenalog.
Intra-articular injection of normal saline
Outcomes
Primary Outcome Measures
Disabilities arm shoulder and hand score
functional score
Secondary Outcome Measures
Pinch Strength
Objective measurement
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03196310
Brief Title
Single Blinded First CMC Osteoarthritis Treatment
Official Title
Randomized Single Blinded First CMC Osteoarthritis Treatment: Therapy and Bracing Alone vs. Intra-Articular Corticosteroid Injection vs Intra-Articular Leukocyte Depleted Platelet Rich Plasma
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kettering Health Network
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
5. Study Description
Brief Summary
Single blinded PRP vs. Corticosteroid vs. Placebo (normal saline) intra-articular injection for basal joint arthritis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis Thumb
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Patients will be blinded to therapy they receive
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PRP
Arm Type
Experimental
Arm Description
Intra-articular injection of platelet rich plasma.
Arm Title
Corticosteroid
Arm Type
Active Comparator
Arm Description
Intra-articular injection of kenalog.
Arm Title
Normal Saline
Arm Type
Placebo Comparator
Arm Description
Intra-articular injection of normal saline
Intervention Type
Drug
Intervention Name(s)
Platelet Concentrate
Intervention Description
Platelet Rich plasma
Intervention Type
Drug
Intervention Name(s)
Corticosteroid injection
Intervention Description
Kenalog
Intervention Type
Other
Intervention Name(s)
Normal Saline
Intervention Description
Control Group - Placebo
Primary Outcome Measure Information:
Title
Disabilities arm shoulder and hand score
Description
functional score
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Pinch Strength
Description
Objective measurement
Time Frame
1 year
Other Pre-specified Outcome Measures:
Title
Visual Analog Score
Description
Pain reduction
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Stage 1-3 osteoarthritis of the basal joint
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Naem Mufarreh
Phone
937-298-4331
Email
naem.mufarreh@ketteringhealth.org
Facility Information:
Facility Name
Orthopedic Associates of Southwest Ohio
City
Centerville
State/Province
Ohio
ZIP/Postal Code
45459
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura Peterson
Phone
800-824-9861
Email
lpeterson@oaswo.com
12. IPD Sharing Statement
Learn more about this trial
Single Blinded First CMC Osteoarthritis Treatment
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