Thumb Base Osteoarthritis: Ultrasound-guided Platelet-rich Plasma Versus Placebo Injection
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) Injections, Saline (0.9% NaCl).
- Who it may be relevant to
- Registry conditions: Thumb Osteoarthritis. Basic parameters: from 18 years · 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
- Center list to be confirmed — check the primary protocol.
- 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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Official title
Thumb Base Osteoarthritis: Ultrasound-guided Platelet-rich Plasma Versus Placebo Injection (Thumbs-up Study)
Overview
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.
Interventions
- Biological Platelet-Rich Plasma (PRP) Injections
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-articul - Drug Saline (0.9% NaCl)
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 stan
Primary outcome measures
- Clinical pain improvement: Visual Analog Scale (VAS) for pain [Time frame: 3, 6, 9 and 12 months]
Secondary outcome measures (4)
- 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]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
- Neuropathic chronic pain syndrome
- Intra articular injection 6 months prior to inclusion
- Smoking
- Active use of statins
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
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07491302 · NL-010929