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Corticosteroid
PRP vs Corticosteroids for Basal Joint Osteoarthritis
N/A
Recruiting
Research Sponsored by Kettering Health Network
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Stage 1-3 osteoarthritis of the basal joint
Be older than 18 years old
Must not have
Patients with Stage 4 1st carpometacarpal joint arthritis as described by Eaton
Patients with Pressier disease, Kienbock's, or avascular necrosis of the scaphoid
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Summary
This trial is testing whether or not a type of blood injection called PRP is more effective than a corticosteroid for treating arthritis in the basal joint.
Who is the study for?
This trial is for people with early to moderate osteoarthritis in the basal joint of the thumb. It's not suitable for those with fibromyalgia, inflammatory diseases, bone tumors, certain wrist conditions like DeQuervain's tenosynovitis recently treated or advanced arthritis as per Eaton stage 4. Pregnant or terminally ill patients and those who've had a corticosteroid injection in the past year at the affected site are also excluded.
What is being tested?
The study tests three treatments: platelet concentrate (PRP), corticosteroid injections, and placebo (normal saline) injected into the joint. Participants won't know which treatment they're getting but will be randomly assigned to one of these options to compare effectiveness.
What are the potential side effects?
Possible side effects include pain at injection site, infection risk increase due to needle insertion, allergic reactions especially from corticosteroids which may also raise blood sugar levels temporarily.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My arthritis in the thumb joint is at an early to moderate stage.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My thumb joint arthritis is severe (Stage 4).
Select...
I have Pressier disease, Kienbock's, or avascular necrosis of the scaphoid.
Select...
I have fibromyalgia or an inflammatory rheumatic disease.
Select...
I've had a corticosteroid injection in my thumb joint within the last year.
Select...
I have arthritis in specific wrist joints.
Select...
I have or was treated for wrist tendon issues in the last 3 months.
Select...
I have had a bone tumor in the past.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Disabilities arm shoulder and hand score
Secondary study objectives
Pinch Strength
Other study objectives
Visual Analog Score
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: PRPExperimental Treatment1 Intervention
Intra-articular injection of platelet rich plasma.
Group II: CorticosteroidActive Control1 Intervention
Intra-articular injection of kenalog.
Group III: Normal SalinePlacebo Group1 Intervention
Intra-articular injection of normal saline
Find a Location
Who is running the clinical trial?
Kettering Health NetworkLead Sponsor
19 Previous Clinical Trials
1,707 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My thumb joint arthritis is severe (Stage 4).I have Pressier disease, Kienbock's, or avascular necrosis of the scaphoid.You are pregnant or have a terminal illness.My arthritis in the thumb joint is at an early to moderate stage.I have fibromyalgia or an inflammatory rheumatic disease.I've had a corticosteroid injection in my thumb joint within the last year.I have arthritis in specific wrist joints.I have or was treated for wrist tendon issues in the last 3 months.I have had a bone tumor in the past.I am being checked for nerve pain in my neck.
Research Study Groups:
This trial has the following groups:- Group 1: Normal Saline
- Group 2: Corticosteroid
- Group 3: PRP
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Osteoarthritis Patient Testimony for trial: Trial Name: NCT03196310 — N/A
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