Osteoarthritis ThumbNCT03196310
Single Blinded First CMC Osteoarthritis Treatment
A study testing Platelet Concentrate, Corticosteroid injection and Normal Saline in people with Osteoarthritis Thumb, run by Kettering Health Network at 1 site in United States.
Trial summary
Single blinded PRP vs. Corticosteroid vs. Placebo (normal saline) intra-articular injection for basal joint arthritis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis Thumb
- What is being tested?
- Platelet Concentrate, Corticosteroid injection and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2018to 31 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stage 1-3 osteoarthritis of the basal joint
Who cannot join
- 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
Show all 9Show fewer
- 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 locations and contacts
1 site in 1 country.
United States1 site
Orthopedic Associates of Southwest Ohio
Centerville, Ohio, 45459
About this study
Official title: 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.
- Conditions
- Osteoarthritis Thumb
- Being tested
- Platelet Concentrate, Corticosteroid injection, Normal Saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet ConcentrateDrug
Platelet Rich plasma
Corticosteroid injectionDrug
Kenalog
Normal SalineOther
Control Group - Placebo
| Study group | Role | What they receive |
|---|---|---|
| PRP | Experimental | Intra-articular injection of platelet rich plasma. Receives: Drug: Platelet Concentrate |
| Corticosteroid | Active comparator | Intra-articular injection of kenalog. Receives: Drug: Corticosteroid injection |
| Normal Saline | Placebo comparator | Intra-articular injection of normal saline Receives: Other: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disabilities arm shoulder and hand score
functional score
Measured: 1 year
Secondary outcomes (1)
Pinch Strength
Objective measurement
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2017
- Study start1 Sep 2018
- Primary completion31 Mar 2025
- Study completion31 Mar 2025
Why it stopped: Due to lack of enrollment, challenging follow-up, and lack of funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis ThumbStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kettering Health Network
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03196310
- Sponsor's protocol ID
- 17-008
- Status last verified
- Apr 2026
- First submitted
- 21 Jun 2017
- Last updated
- 8 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Single Blinded First CMC Osteoarthritis Treatment: Therapy and Bracing Alone vs. Intra-Articular Corticosteroid Injection vs Intra-Articular Leukocyte Depleted Platelet Rich Plasma
- ClinicalTrials.gov ID
- NCT03196310
- Acronym / sponsor ID
- 17-008
- Conditions
- Osteoarthritis Thumb
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to lack of enrollment, challenging follow-up, and lack of funding.
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Kettering Health NetworkUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 22 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Single blinded PRP vs. Corticosteroid vs. Placebo (normal saline) intra-articular injection for basal joint arthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PRP | Experimental | Drug: Platelet ConcentrateIntra-articular injection of platelet rich plasma. |
| Corticosteroid | Active comparator | Drug: Corticosteroid injectionIntra-articular injection of kenalog. |
| Normal Saline | Placebo comparator | Other: Normal SalineIntra-articular injection of normal saline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Stage 1-3 osteoarthritis of the basal joint
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Platelet ConcentratePlatelet Rich plasma | Drug | PRP |
| Corticosteroid injectionKenalog | Drug | Corticosteroid |
| Normal SalineControl Group - Placebo | Other | Normal Saline |
Primary outcome
Disabilities arm shoulder and hand score
Time frame: 1 year
functional score
1 secondary outcome
Pinch Strength
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Due to lack of enrollment, challenging follow-up, and lack of funding.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Platelet Concentrate, Corticosteroid injection and Normal Saline in people with Osteoarthritis Thumb, run by Kettering Health Network at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Due to lack of enrollment, challenging follow-up, and lack of funding.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disabilities arm shoulder and hand score (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.