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This is a randomized double-blinded randomized comparison between injection of platelet rich plasma (PRP) and placebo for thumb basale osteoarthritis.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Platelet rich plasma (PRP) | Active Comparator | High-concentration PRP injection PRP injection (0,6-1ml). Arthrex ACPmax system. |
|
| Placebo | Placebo Comparator | intraarticular saline injection (0,6-1ml) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Platelet rich plasma (PRP) | Procedure | Intra-articular injection of platelet rich plasma (PRP) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain on load in thumb | Pain on load (numerical rating scale (NRS) 0-100, higher score represents more pain) | 6 months after the first injection. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient-rated Wrist and Hand (PRWHE) score | 0-100, higher score represents more disability | 3 months |
| Patient-rated Wrist and Hand (PRWHE) score | 0-100, higher score represents more disability |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maria Wilcke, MD, PhD | Contact | +46708294613 | maria.wilcke@regionstockholm.se | |
| Johanna VonKieseritzky, MD. PhD | Contact | johanna.vonkieseritzky@regionstockholm.se |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Hand Surgery Södersjukhuset | Recruiting | Stockholm | S-11883 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39587622 | Derived | 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. |
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Randomized controlled trial
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blind fold on participants. No infomration about given treatment to outcome assessors.
| Placebo | Other | Intra-articular Saline injection (0,6-1ml) |
|
| 6 months |
| Patient-rated Wrist and Hand (PRWHE) score | 0-100, higher score represents more disability | 12 months |
| Nelson thumb score | 0-100, lower score represents more symptoms | 3 months |
| Nelson thumb score | 0-100, lower score represents more symptoms | 6 months |
| Nelson thumb score | 0-100, lower score represents more symptoms | 12 months |
| HAKIR symptom score (HQ-8) | 0-100, lower score represents more symptoms | 3 months |
| HAKIR symptom score (HQ-8) | 0-100, lower score represents more symptoms | 6 months |
| HAKIR symptom score (HQ-8) | 0-100, lower score represents more symptoms | 12 months |
| key pinch and pinch strength | key pinch and pinch strength (kg) | 3 months |
| key pinch and pinch strength | key pinch and pinch strength (kg) | 6 months |
| key pinch and pinch strength | key pinch and pinch strength (kg) | 12 months |
| Radial and palmar abduction | Radial and palmar abduction of the first metacarpal (degrees) | 3 months |
| Radial and palmar abduction | Radial and palmar abduction of the first metacarpal (degrees) | 6 months |
| Radial and palmar abduction | Radial and palmar abduction of the first metacarpal (degrees) | 12 months |