Single Blinded First CMC Osteoarthritis Treatment

Study Purpose

Single blinded PRP vs.#46; Corticosteroid vs.#46; Placebo (normal saline) intra-articular injection for basal joint arthritis.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03196310
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Kettering Health Network
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Osteoarthritis Thumb

Arms & Interventions

Arms

Experimental: PRP

Intra-articular injection of platelet rich plasma.

Active Comparator: Corticosteroid

Intra-articular injection of kenalog.

Placebo Comparator: Normal Saline

Intra-articular injection of normal saline

Interventions

Drug: - Platelet Concentrate

Platelet Rich plasma

Drug: - Corticosteroid injection

Kenalog

Other: - Normal Saline

Control Group - Placebo

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Orthopedic Associates of Southwest Ohio, Centerville, Ohio

Status

Recruiting

Address

Orthopedic Associates of Southwest Ohio

Centerville, Ohio, 45459

Site Contact

Laura Peterson

[email protected]

800-824-9861

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