Single Blinded First CMC Osteoarthritis Treatment

March 26, 2024 updated by: Kettering Health Network

Randomized Single Blinded First CMC Osteoarthritis Treatment: Therapy and Bracing Alone vs. Intra-Articular Corticosteroid Injection vs Intra-Articular Leukocyte Depleted Platelet Rich Plasma

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Ohio
      • Centerville, Ohio, United States, 45459
        • Recruiting
        • Orthopedic Associates of Southwest Ohio
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PRP
Intra-articular injection of platelet rich plasma.
Drug: Platelet Concentrate
Platelet Rich plasma
Active Comparator: Corticosteroid
Intra-articular injection of kenalog.
Drug: Corticosteroid injection
Kenalog
Placebo Comparator: Normal Saline
Intra-articular injection of normal saline
Other: Normal Saline
Control Group - Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disabilities arm shoulder and hand score
Time Frame: 1 year
functional score
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pinch Strength
Time Frame: 1 year
Objective measurement
1 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog Score
Time Frame: 1 year
Pain reduction
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kettering Health Network

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2018

Primary Completion (Estimated)

March 31, 2025

Study Completion (Estimated)

March 31, 2025

Study Registration Dates

First Submitted

June 21, 2017

First Submitted That Met QC Criteria

June 21, 2017

First Posted (Actual)

June 22, 2017

Study Record Updates

Last Update Posted (Actual)

March 28, 2024

Last Update Submitted That Met QC Criteria

March 26, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-008

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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