Osteoarthritis ThumbNCT06193499
A Study on the Effect of High-concentrated Platelet Rich Plasma (PRP) on Osteoarthritis in the Thumb Base.
A study testing Platelet rich plasma (PRP) in people with Osteoarthritis Thumb, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
This is a randomized double-blinded randomized comparison between injection of platelet rich plasma (PRP) and placebo for thumb basale osteoarthritis. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteoarthritis Thumb
- What is being tested?
- Platelet rich plasma (PRP)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteSweden
- Study dates
- 17 Jan 2024to 31 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
This is a randomized double-blinded randomized comparison between injection of platelet rich plasma (PRP) and placebo for thumb basale osteoarthritis.
Read the 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.
- Conditions
- Osteoarthritis Thumb
- Being tested
- Platelet rich plasma (PRP), Placebo
- Keywords
- CMC-1 joint, thumb basal joint, PRP, Platelet-rich plasma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet rich plasma (PRP)Procedure or surgery
Intra-articular injection of platelet rich plasma (PRP)
PlaceboOther
Intra-articular Saline injection (0,6-1ml)
| Study group | Role | What they receive |
|---|---|---|
| Platelet rich plasma (PRP) | Active comparator | High-concentration PRP injection PRP injection (0,6-1ml). Arthrex ACPmax system. Receives: Procedure: Platelet rich plasma (PRP) |
| Placebo | Placebo comparator | intraarticular saline injection (0,6-1ml) Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain on load in thumb
Pain on load (numerical rating scale (NRS) 0-100, higher score represents more pain)
Measured: 6 months after the first injection.
Secondary outcomes (15)
Patient-rated Wrist and Hand (PRWHE) score
0-100, higher score represents more disability
Measured: 3 months
Patient-rated Wrist and Hand (PRWHE) score
0-100, higher score represents more disability
Measured: 6 months
Patient-rated Wrist and Hand (PRWHE) score
0-100, higher score represents more disability
Measured: 12 months
Nelson thumb score
0-100, lower score represents more symptoms
Measured: 3 months
Nelson thumb score
0-100, lower score represents more symptoms
Measured: 6 months
Nelson thumb score
0-100, lower score represents more symptoms
Measured: 12 months
HAKIR symptom score (HQ-8)
0-100, lower score represents more symptoms
Measured: 3 months
HAKIR symptom score (HQ-8)
0-100, lower score represents more symptoms
Measured: 6 months
HAKIR symptom score (HQ-8)
0-100, lower score represents more symptoms
Measured: 12 months
key pinch and pinch strength
key pinch and pinch strength (kg)
Measured: 3 months
key pinch and pinch strength
key pinch and pinch strength (kg)
Measured: 6 months
key pinch and pinch strength
key pinch and pinch strength (kg)
Measured: 12 months
Radial and palmar abduction
Radial and palmar abduction of the first metacarpal (degrees)
Measured: 3 months
Radial and palmar abduction
Radial and palmar abduction of the first metacarpal (degrees)
Measured: 6 months
Radial and palmar abduction
Radial and palmar abduction of the first metacarpal (degrees)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start17 Jan 2024
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis ThumbStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- 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
- Model description
- Randomized controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Wilcke, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06193499
- Sponsor's protocol ID
- PRP2.0
- Status last verified
- Aug 2026
- First submitted
- 20 Dec 2023
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 39587622
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Effect of High-concentrated Platelet Rich Plasma (PRP) on Osteoarthritis in the Thumb Base.
- ClinicalTrials.gov ID
- NCT06193499
- Acronym / sponsor ID
- PRP2.0
- Conditions
- Osteoarthritis Thumb
- Keywords
- CMC-1 joint, thumb basal joint, PRP, Platelet-rich plasma
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 17 Jan 2024 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 5 Jan 2024 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Platelet rich plasma (PRP) | Active comparator | Procedure: Platelet rich plasma (PRP)High-concentration PRP injection PRP injection (0,6-1ml). Arthrex ACPmax system. |
| Placebo | Placebo comparator | Other: Placebointraarticular saline injection (0,6-1ml) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (7 listed)
- 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.
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 rich plasma (PRP)Intra-articular injection of platelet rich plasma (PRP) | Procedure or surgery | Platelet rich plasma (PRP) |
| PlaceboIntra-articular Saline injection (0,6-1ml) | Other | Placebo |
Primary outcome
Pain on load in thumb
Time frame: 6 months after the first injection.
Pain on load (numerical rating scale (NRS) 0-100, higher score represents more pain)
15 secondary outcomes
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
Radial and palmar abduction
Time frame: 3 months
Radial and palmar abduction
Time frame: 6 months
Radial and palmar abduction
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Derived from this study: PubMed 39587622von 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.
- Individual participant dataSharing planned: No
Related trials for Osteoarthritis Thumb
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Thumb Osteoarthritis, Thumb Carpometacarpal Joint Osteoarthritis
Not yet recruitingObservational study
Thumb Muscle Activation During Different Activities of Daily Living in Thumb Base Osteoarthritis and Healthy Controls
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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 rich plasma (PRP) in people with Osteoarthritis Thumb, run by Karolinska Institutet at 1 site in Sweden.
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 3 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 10 Aug 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 Sweden. 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?
This study is still under way. Results are not available in the source record yet.
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?
Pain on load in thumb (time frame: 6 months after the first injection.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06193499, which also lists 1 linked publication.
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 10 Aug 2026.