Single Blinded First CMC Osteoarthritis Treatment

Not Applicable

Recruiting

• Conditions: Osteoarthritis Thumb
• Interventions: Drug: Platelet Concentrate; Drug: Corticosteroid injection; Other: Normal Saline

• Registration Number: NCT03196310
• Lead Sponsor: Kettering Health Network

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-06-21
• Study First Submitted QC: 2017-06-21
• Study First Posted: 2017-06-22
• Study Start: 2018-09-01
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-26
• Last Update Posted: 2024-03-28
• Primary Completion: 2025-03-31
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PRP	Platelet Concentrate	Intra-articular injection of platelet rich plasma.
Corticosteroid	Corticosteroid injection	Intra-articular injection of kenalog.
Normal Saline	Normal Saline	Intra-articular injection of normal saline

Primary Outcome Measures

Name	Time	Method
Disabilities arm shoulder and hand score	1 year	functional score

Secondary Outcome Measures

Name	Time	Method
Pinch Strength	1 year	Objective measurement

Trial Locations

Locations (1)

Orthopedic Associates of Southwest Ohio; 🇺🇸 Centerville, Ohio, United States