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| Name | Class |
|---|---|
| Arthrex, Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Platelet-rich plasma group A | Experimental |
| |
| Placebo group B | Placebo Comparator | Saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Platelet-Rich Plasma (PRP) Injections | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3, 6, 9 and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D007267 | Injections |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D002712 | Chlorides |
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| Saline (0.9% NaCl) | Drug | 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. |
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| 3, 6, 9 and 12 months |
| 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 | 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. | 3, 6, 9 and 12 months |
| D006851 |
| Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |