A Study on the Effect of High-concentrated Platelet Rich Plasma (PRP) on Osteoarthritis in the Thumb Base.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Platelet rich plasma (PRP), Placebo.
- Who it may be relevant to
- Registry conditions: Osteoarthritis Thumb. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
This is a randomized double-blinded randomized comparison between injection of platelet rich plasma (PRP) and placebo for thumb basale osteoarthritis.
Detailed description
The aim of this study is to evaluate if high-concentration PRP injection decreases pain and disability in patients with thumb base osteoarthritis in the short-term and compare the effect to placebo.90 patients will be inlcuded (45+45). The primary outcome is pain on load (numerical rating scale) after 6 months. Patient-rated outcome measures, pinch grip and key pinch, range of motion of the CMC.1 joint will be assessed before treatment and at 3, 6 and months after the injection. Participants and assessors will be blinded.
Interventions
- Procedure Platelet rich plasma (PRP)
Intra-articular injection of platelet rich plasma (PRP) - Other Placebo
Intra-articular Saline injection (0,6-1ml)
Primary outcome measures
- Pain on load in thumb [Time frame: 6 months after the first injection.]
Secondary outcome measures (12)
- Patient-rated Wrist and Hand (PRWHE) score [Time frame: 3 months]
- Patient-rated Wrist and Hand (PRWHE) score [Time frame: 6 months]
- Patient-rated Wrist and Hand (PRWHE) score [Time frame: 12 months]
- Nelson thumb score [Time frame: 3 months]
- Nelson thumb score [Time frame: 6 months]
- Nelson thumb score [Time frame: 12 months]
- HAKIR symptom score (HQ-8) [Time frame: 3 months]
- HAKIR symptom score (HQ-8) [Time frame: 6 months]
- HAKIR symptom score (HQ-8) [Time frame: 12 months]
- key pinch and pinch strength [Time frame: 3 months]
- key pinch and pinch strength [Time frame: 6 months]
- key pinch and pinch strength [Time frame: 12 months]
Eligibility criteria
Inclusion criteria
- Osteoarthritis in the thumb base
- Radiological Eaton Littler class 1-3.
- Clinical signs of thumb base osteoarthritis )pain at palpation of the CMC-1 joint and pain during provocation/grinding test).
Exclusion criteria
- Rheumatoid arthritis
- Ongoing infection in the hand or wrist
- History of gout or pseudogout in the hand
- Inability to co-operate with the follow-up protocol (language difficulties, severe psychiatric disorder, cognitive impairment, drug addiction).
- Chronic pain syndrome / centralized pain.
- Intra-articular injection in the affected joint within 6 months.
- Eaton Littler class 4 (symptomatic STT joint osteoarthritis).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Sweden · 1 center
- Department of Hand Surgery Södersjukhuset — Stockholm
Publications
- von Kieseritzky J, Wilcke M. High-concentrated platelet-rich plasma (PRP) versus placebo in osteoarthritis in the thumb base: study protocol for an assessor-blinded randomized controlled trial. Trials. 2024 Nov 26;25(1):797. doi: 10.1186/s13063-024-08636-2. PMID 39587622
Identifiers
NCT: NCT06193499 · PRP2.0