Single Blinded First CMC Osteoarthritis Treatment

NCT ID: NCT03196310

Last Updated: 2024-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-01

Study Completion Date

2025-03-31

Brief Summary

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

Detailed Description

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Conditions

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Osteoarthritis Thumb

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
Patients will be blinded to therapy they receive

Study Groups

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PRP

Intra-articular injection of platelet rich plasma.

Group Type EXPERIMENTAL

Platelet Concentrate

Intervention Type DRUG

Platelet Rich plasma

Corticosteroid

Intra-articular injection of kenalog.

Group Type ACTIVE_COMPARATOR

Corticosteroid injection

Intervention Type DRUG

Kenalog

Normal Saline

Intra-articular injection of normal saline

Group Type PLACEBO_COMPARATOR

Normal Saline

Intervention Type OTHER

Control Group - Placebo

Interventions

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Platelet Concentrate

Platelet Rich plasma

Intervention Type DRUG

Corticosteroid injection

Kenalog

Intervention Type DRUG

Normal Saline

Control Group - Placebo

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kettering Health Network

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Orthopedic Associates of Southwest Ohio

Centerville, Ohio, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Naem Mufarreh

Role: CONTACT

937-298-4331

Facility Contacts

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Laura Peterson

Role: primary

800-824-9861

Other Identifiers

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17-008

Identifier Type: -

Identifier Source: org_study_id

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