High-concentrated platelet-rich plasma (PRP) versus placebo in osteoarthritis in the thumb base: study protocol for an assessor-blinded randomized controlled trial.
Johanna von Kieseritzky, Maria Wilcke
https://pubmed.ncbi.nlm.nih.gov/39587622Actively Recruiting
Phase Not Applicable
All Genders
ID06193499
A Study on the Effect of High-concentrated Platelet Rich Plasma (PRP) on Osteoarthritis in the Thumb Base.
Led by Karolinska Institutet · Updated on 2025-06-03
90
Participants Needed
1
Research Sites
25 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate whether injecting high-concentration platelet rich plasma (PRP) can reduce pain and disability in patients with osteoarthritis at the base of the thumb. The study compares this treatment to a placebo injection to see if there is a difference in short-term effects. It involves 90 patients and is designed as a double-blinded randomized trial to ensure unbiased results. Participants will be randomly assigned to receive either an injection of high-concentration PRP (0.6-1 ml) using the Arthrex ACPmax system or a placebo injection of saline (0.6-1 ml) into the thumb base joint. The treatments are given once, and both participants and those assessing outcomes will not know which treatment was administered to maintain blinding. During the study, patients will be assessed before treatment and then at 3, 6, and 12 months after the injection. Researchers will measure pain during thumb movement, hand function scores, pinch strength, and thumb joint motion. The main focus is pain on load at 6 months. These evaluations will help determine if PRP injections have benefits compared to placebo over time.
CONDITIONS
Brief Title
A Study on the Effect of High-concentrated Platelet Rich Plasma (PRP) on Osteoarthritis in the Thumb Base.
Who Can Participate
All Genders
Eligibility Criteria
You may qualify if you...
- Osteoarthritis in the thumb base
- Radiological Eaton Littler class 1-3
- Clinical signs of thumb base osteoarthritis including pain at palpation of the CMC-1 joint and pain during provocation or grinding test
You will not qualify if you...
- Rheumatoid arthritis
- Ongoing infection in the hand or wrist
- History of gout or pseudogout in the hand
- Inability to cooperate with follow-up (language difficulties, severe psychiatric disorder, cognitive impairment, drug addiction)
- Chronic pain syndrome or centralized pain
- Intra-articular injection in the affected joint within 6 months
- Eaton Littler class 4 (symptomatic STT joint osteoarthritis)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Single injection visit with follow-up assessments up to 12 months
Participants receive an intra-articular injection of either high-concentration platelet rich plasma (PRP) or placebo (saline) in the thumb base joint.
1 injection visit and follow-up visits at 3, 6, and 12 months
Trial Site Locations
Total: 1 location
1
Department of Hand Surgery Södersjukhuset
Stockholm, Sweden, S-11883
Actively Recruiting
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Research Team
M
Maria Wilcke, MD, PhD
J
Johanna VonKieseritzky, MD. PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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