Thumb OsteoarthritisPhase 2Thumbs-upNCT07491302
Thumb Base Osteoarthritis: Ultrasound-guided Platelet-rich Plasma Versus Placebo Injection
A Phase 2 study testing Platelet-Rich Plasma (PRP) Injections and Saline (0.9% NaCl) in people with Thumb Osteoarthritis, run by Goed Medisch Centrum at 1 site in Netherlands.
Trial summary
The goal of this clinical trial is to evaluate whether platelet-rich plasma (PRP) injections improve pain and function in adults with thumb base osteoarthritis (CMC-I OA). The main questions it aims to answer are: Does a PRP injection reduce pain compared to a placebo (saline) injection? Does PRP improve hand… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thumb Osteoarthritis
- What is being tested?
- Platelet-Rich Plasma (PRP) Injections and Saline (0.9% NaCl)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteNetherlands
- Study dates
- 20 May 2026to Jun 2027
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 or older
- Patients with an Eaton-littler score of I, II or III
- Patients with uni- or bilateral CMC-I osteoarthritis
- Non-responders to conservative therapy i.e., hand therapy and immobilisation after 3 months
Who cannot join
- Aged below 18
- Patients with an Eaton-littler score of IV (STT arthrosis)
- Surgical interventions of the CMC-I joint
- A known articular systemic disease (e.g. rheumatoid arthritis) or additional hand osteoarthritis/ tenosynovitis or metabolic disease like diabetes mellitus
- Patients with an infectious arthritis of CMC-I joint
- A known psychiatric condition
Show all 10Show fewer
- Neuropathic chronic pain syndrome
- Intra articular injection 6 months prior to inclusion
- Smoking
- Active use of statins
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
GOED Medisch Centrum
Breda, North Brabant, 4811HR
Van Dongen MD PhD, +31619594029, joris@goedmedischcentrum.nl
About this study
Official title: Thumb Base Osteoarthritis: Ultrasound-guided Platelet-rich Plasma Versus Placebo Injection (Thumbs-up Study)
The goal of this clinical trial is to evaluate whether platelet-rich plasma (PRP) injections improve pain and function in adults with thumb base osteoarthritis (CMC-I OA).
The main questions it aims to answer are:
Read more
Does a PRP injection reduce pain compared to a placebo (saline) injection? Does PRP improve hand function, strength, and thumb mobility? What adverse events occur following PRP treatment?
Researchers will compare PRP injections to a placebo injection (saline solution) to determine whether PRP is an effective treatment for CMC-I osteoarthritis.
Participants will:
Receive a single ultrasound-guided injection of PRP or placebo (saline) in the CMC-I joint.
Attend follow-up visits at 3, 6, 9, and 12 months for clinical assessments. Complete questionnaires on pain (VAS) and hand function (MHQ-DLV) at multiple time points.
Undergo physical examinations (grip strength, pinch strength, thumb motion). Undergo ultrasound evaluations to assess joint characteristics.
- Conditions
- Thumb Osteoarthritis
- Being tested
- Platelet-Rich Plasma (PRP) Injections, Saline (0.9% NaCl)
- Keywords
- platelet-rich plasma, CMC-I joint, carpometacarpal joint osteoarthritis, Thumb base osteoarthritis, PRP injection, Placebo-controlled trial, Orthobiologics, Regenerative medicine, Ultrasound-guided injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet-Rich Plasma (PRP) InjectionsBiological
Autologous platelet-rich plasma (PRP) is prepared from 90 mL of the participant's venous blood using a standardized two-step centrifugation protocol (ACP® Max system, Arthrex Inc.). The first centrifugation is performed at 3200 rpm for 9 minutes, followed by a second centrifugation at 1500 rpm for 5 minutes, resulting in approximately 2 mL of PRP. A single injection of 2 mL PRP is administered under sterile conditions and ultrasound guidance into the CMC-I joint, consisting of 1 mL intra-articular and 1 mL peri-articular injection. No repeated injections are performed.
Saline (0.9% NaCl)Drug
Also called Placebo injection
Participants receive a placebo injection consisting of 2 mL sterile saline (0.9% NaCl), administered under sterile conditions and ultrasound guidance into the CMC-I joint. The injection protocol is identical to the PRP group, with 1 mL injected intra-articularly and 1 mL peri-articularly. To maintain blinding, participants in the placebo group undergo a venous blood draw mimicking the PRP preparation procedure; however, the collected blood is discarded. The duration and procedural steps are standardized to ensure comparable treatment conditions between groups. No repeated injections are performed.
| Study group | Role | What they receive |
|---|---|---|
| Platelet-rich plasma group A | Experimental | Not described Receives: Biological: Platelet-Rich Plasma (PRP) Injections |
| Placebo group B | Placebo comparator | Saline Receives: Drug: Saline (0.9% NaCl) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pain improvement: Visual Analog Scale (VAS) for pain
Pain will be assessed using the Visual Analog Scale (VAS), a continuous scale ranging from 0 to 100, where 0 indicates no pain and 100 indicates worst imaginable pain. A decrease in VAS score reflects an improvement in pain.
Measured: 3, 6, 9 and 12 months
Secondary outcomes (4)
Functional improvement: Michigan Hand Outcomes Questionnaire (MHQ-DLV)
Hand function will be assessed using the Michigan Hand Outcomes Questionnaire (MHQ), Dutch Language Version (MHQ-DLV). The MHQ is a patient-reported outcome measure consisting of multiple domains (including overall hand function, activities of daily living, pain, work performance, aesthetics, and patient satisfaction), each scored on a scale from 0 to 100. For all domains except pain, higher scores indicate better hand function and greater satisfaction. For the pain domain, higher scores indicate more severe pain.
Measured: 3, 6, 9 and 12 months
Functional improvement: Grip and pinch test
Measured: 3, 6, 9 and 12 months
Functional improvement: Opposition of the thumb (pollexograph)
Measured: 3, 6, 9 and 12 months
Functional improvement: Kapandji Opposition Score
Thumb opposition will be assessed using the Kapandji Opposition Score, a clinical scale ranging from 0 to 10, where 0 indicates no opposition and 10 indicates maximal opposition of the thumb across the palm. Higher scores indicate better thumb function and greater range of opposition.
Measured: 3, 6, 9 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study start20 May 2026
- Primary completionMay 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thumb OsteoarthritisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Goed Medisch Centrum
- Sponsor type
- University, hospital or other
- Collaborators
- Arthrex, Inc.
- Responsible party
- Principal investigator, Evi Loos, Goed Medisch Centrum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07491302
- Sponsor's protocol ID
- NL-010929
- Acronym
- Thumbs-up
- Status last verified
- Sep 2026
- First submitted
- 18 Mar 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thumb Base Osteoarthritis: Ultrasound-guided Platelet-rich Plasma Versus Placebo Injection (Thumbs-up Study)
- ClinicalTrials.gov ID
- NCT07491302
- Acronym / sponsor ID
- Thumbs-up / NL-010929
- Conditions
- Thumb Osteoarthritis
- Keywords
- platelet-rich plasma, CMC-I joint, carpometacarpal joint osteoarthritis, Thumb base osteoarthritis, PRP injection, Placebo-controlled trial, Orthobiologics, Regenerative medicine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Goed Medisch CentrumUniversity, hospital or other
- Collaborators
- Arthrex, Inc.
- Study start
- 20 May 2026 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 24 Mar 2026 (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.
The goal of this clinical trial is to evaluate whether platelet-rich plasma (PRP) injections improve pain and function in adults with thumb base osteoarthritis (CMC-I OA).
The main questions it aims to answer are:
Does a PRP injection reduce pain compared to a placebo (saline) injection? Does PRP improve hand function, strength, and thumb mobility? What adverse events occur following PRP treatment?
Researchers will compare PRP injections to a placebo injection (saline solution) to determine whether PRP is an effective treatment for CMC-I osteoarthritis.
Participants will:
Receive a single ultrasound-guided injection of PRP or placebo (saline) in the CMC-I joint.
Attend follow-up visits at 3, 6, 9, and 12 months for clinical assessments. Complete questionnaires on pain (VAS) and hand function (MHQ-DLV) at multiple time points.
Undergo physical examinations (grip strength, pinch strength, thumb motion). Undergo ultrasound evaluations to assess joint characteristics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Platelet-rich plasma group A | Experimental | Biological: Platelet-Rich Plasma (PRP) Injections |
| Placebo group B | Placebo comparator | Drug: Saline (0.9% NaCl)Saline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 or older
- Patients with an Eaton-littler score of I, II or III
- Patients with uni- or bilateral CMC-I osteoarthritis
- Non-responders to conservative therapy i.e., hand therapy and immobilisation after 3 months
Key exclusion criteria (10 listed)
- Aged below 18
- Patients with an Eaton-littler score of IV (STT arthrosis)
- Surgical interventions of the CMC-I joint
- A known articular systemic disease (e.g. rheumatoid arthritis) or additional hand osteoarthritis/ tenosynovitis or metabolic disease like diabetes mellitus
- Patients with an infectious arthritis of CMC-I joint
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) InjectionsAutologous platelet-rich plasma (PRP) is prepared from 90 mL of the participant's venous blood using a standardized two-step centrifugation protocol (ACP® Max system, Arthrex Inc.). The first centrifugation is performed at 3200 rpm for 9 minutes, followed by a second centrifugation at 1500 rpm for 5 minutes, resulting in approximately 2 mL of PRP. A single injection of 2 mL PRP is administered under sterile conditions and ultrasound guidance into the CMC-I joint, consisting of 1 mL intra-articular and 1 mL peri-articular injection. No repeated injections are performed. | Biological | Platelet-rich plasma group A |
| Saline (0.9% NaCl)Also: Placebo injectionParticipants receive a placebo injection consisting of 2 mL sterile saline (0.9% NaCl), administered under sterile conditions and ultrasound guidance into the CMC-I joint. The injection protocol is identical to the PRP group, with 1 mL injected intra-articularly and 1 mL peri-articularly. To maintain blinding, participants in the placebo group undergo a venous blood draw mimicking the PRP preparation procedure; however, the collected blood is discarded. The duration and procedural steps are standardized to ensure comparable treatment conditions between groups. No repeated injections are performed. | Drug | Placebo group B |
Primary outcome
Clinical pain improvement: Visual Analog Scale (VAS) for pain
Time frame: 3, 6, 9 and 12 months
Pain will be assessed using the Visual Analog Scale (VAS), a continuous scale ranging from 0 to 100, where 0 indicates no pain and 100 indicates worst imaginable pain. A decrease in VAS score reflects an improvement in pain.
4 secondary outcomes
Functional improvement: Michigan Hand Outcomes Questionnaire (MHQ-DLV)
Time frame: 3, 6, 9 and 12 months
Functional improvement: Grip and pinch test
Time frame: 3, 6, 9 and 12 months
Functional improvement: Opposition of the thumb (pollexograph)
Time frame: 3, 6, 9 and 12 months
Functional improvement: Kapandji Opposition Score
Time frame: 3, 6, 9 and 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 5 Oct 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Platelet-Rich Plasma (PRP) Injections and Saline (0.9% NaCl) in people with Thumb Osteoarthritis, run by Goed Medisch Centrum at 1 site in Netherlands.
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 4 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 5 Oct 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 Netherlands. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical pain improvement: Visual Analog Scale (VAS) for pain (time frame: 3, 6, 9 and 12 months). 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 5 Oct 2026.