Single Blinded First CMC Osteoarthritis Treatment | NCT03196310

Studies
Single Blinded First CMC Osteoarthritis Treatment

NCT03196310

Sponsor

Kettering Health Network

Status

Terminated

Last Update Posted

Apr 8, 2026Actual

Enrollment

74Actual

Phase

Not Applicable

Conditions

Osteoarthritis Thumb

Interventions

Platelet Concentrate
Corticosteroid injection
Normal Saline

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Due to lack of enrollment, challenging follow-up, and lack of funding.

Expanded Access Info

Start Date

Sep 1, 2018Actual

Primary Completion Date

Mar 31, 2025Actual

Completion Date

Mar 31, 2025Actual

First Submitted Date

Jun 21, 2017

First Submission Date that Met QC Criteria

Jun 21, 2017

First Posted Date

Jun 22, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 2, 2026

Last Update Posted Date

Apr 8, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

74Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PRP	Experimental	Intra-articular injection of platelet rich plasma.	Drug: Platelet Concentrate
Corticosteroid	Active Comparator	Intra-articular injection of kenalog.	Drug: Corticosteroid injection
Normal Saline	Placebo Comparator	Intra-articular injection of normal saline	Other: Normal Saline

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Platelet Concentrate	Drug	Platelet Rich plasma	PRP
Corticosteroid injection

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Pinch Strength	Objective measurement	1 year

Other Outcomes

Measure	Description	Time Frame
Visual Analog Score	Pain reduction	1 year

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Orthopedic Associates of Southwest Ohio		Centerville	Ohio	45459	United States

Intervention Browse Module

MeSH Terms

ID	Term
D000305	Adrenal Cortex Hormones
D000077330	Saline Solution

Ancestor Terms

ID	Term
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists
D000077324	Crystalloid Solutions
D007552	Isotonic Solutions

Browse Leaves

Not provided

Browse Branches

Not provided