Thumb Osteoarthritis
Conditions
Keywords
platelet-rich plasma, CMC-I joint, carpometacarpal joint osteoarthritis, Thumb base osteoarthritis, PRP injection, Placebo-controlled trial, Orthobiologics, Regenerative medicine, Ultrasound-guided injection
Brief 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 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
DRUGSaline (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 standardized to ensure comparable treatment conditions between groups. No repeated injections are performed.
BIOLOGICALPlatelet-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-articular and 1 mL peri-articular injection. No repeated injections are performed.
Sponsors
Goed Medisch Centrum
Arthrex, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical pain improvement: Visual Analog Scale (VAS) for pain | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional improvement: Michigan Hand Outcomes Questionnaire (MHQ-DLV) | 3, 6, 9 and 12 months | 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. |
| Functional improvement: Grip and pinch test | 3, 6, 9 and 12 months | — |
| Functional improvement: Opposition of the thumb (pollexograph) | 3, 6, 9 and 12 months | — |
| Functional improvement: Kapandji Opposition Score | 3, 6, 9 and 12 months | 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. |
Outcome results
None listed