Single Blinded First CMC Osteoarthritis Treatment

Osteoarthritis Thumb Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03196310
• Other study ID #: 17-008
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2018
• Est. completion date: March 31, 2025

Study information

• Verified date: March 2024
• Source: Kettering Health Network
• Contact: Naem Mufarreh
• Phone: 937-298-4331
• Email: naem.mufarreh[@]ketteringhealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Single blinded PRP vs. Corticosteroid vs. Placebo (normal saline) intra-articular injection for basal joint arthritis.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: March 31, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis Thumb

Intervention

Drug:
• Platelet Concentrate
Platelet Rich plasma
• Corticosteroid injection
Kenalog

Other:
• Normal Saline
Control Group - Placebo

Locations

Country	Name	City	State
United States	Orthopedic Associates of Southwest Ohio	Centerville	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Kettering Health Network

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Visual Analog Score	Pain reduction	1 year
Primary	Disabilities arm shoulder and hand score	functional score	1 year
Secondary	Pinch Strength	Objective measurement	1 year