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| Name | Class |
|---|---|
| Tampere University Hospital | OTHER |
| Turku University Hospital | OTHER_GOV |
| Jyväskylä Central Hospital | OTHER |
| Kymenlaakso Central Hospital Kotka Finland |
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Study purpose is to compare the outcome after proximal row carpectomy (PRC) vs four-corner fusion (FCA) for SLAC/SNAC II-III type osteoarthritis (OA) in a double-blinded randomized controlled study setting.
Patients with radiologically and clinically confirmed OA are randomized (1:1 computer generated sequence with random block size) to two parallel groups and will undergo either PRC or FCA. The study will be patient and assessor blinded.
Baseline data is collected preoperatively and is followed by a follow-up visits at 2 and 6 weeks, 3, 6, 12 months, and 5, 10 years after the intervention. Unveiling of the allocation is at 12 months post-intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Proximal Row Carpectomy | Experimental |
| |
| Four-corner fusion | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Proximal Row Carpectomy | Procedure | Excision of the proximal carpal row - the scaphoid, lunate and triquetrum |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient-Rated Wrist Evaluation | The PRWE comprises 15 questions to measure wrist pain and disability in daily activities. In PRWE patients rate wrist pain and disability from 0 to 10 and it consists two subscales: Pain and Function (0=best possible outcome, 10=worst possible outcome) | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Quick-Disabilities of the Arm, Shoulder and Hand | The QuickDASH is self-reported questionnaire and shortened version of DASH outcome measure to measure physical function and symptoms in people with any or multiple musculoskeletal disorders of the upper limb in 11 dimensions in 1-5 scale (1=best possible outcome, 5=worst possible outcome) | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Samuli Aspinen, MD, PhD | Contact | +358406360546 | samuli.aspinen@hus.fi | |
| Jorma Ryhänen, adj. prof. | Contact | jorma.ryhanen@hus.fi |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Töölö Hospital (Helsinki University Hospital) | Recruiting | Helsinki | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37550711 | Derived | Alanen M, Stjernberg-Salmela S, Waris E, Karjalainen T, Miettunen J, Ryhanen J, Aspinen S. Proximal ROw carpectOmy versus four-corner Fusion (PROOF-trial) for osteoarthritis of the wrist: study protocol for multi-institutional double-blinded randomized controlled trial. Trials. 2023 Aug 7;24(1):499. doi: 10.1186/s13063-023-07544-1. |
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| OTHER |
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| Four-corner fusion | Procedure | Scaphoid excision and four-corner fusion with cannulated headless compression screws/dorsal plate |
|
| Pain (Visual Analogue Scale) | The VAS is derived by health care professional question of pain in scale 0 to 10 (0=no pain, 10=worst possible pain) | 12 months |
| Global improvement | Global rating to treatment effect will be evaluated by question: "How would you rate the function of your hand compared to the situation before the treatment?". The options are in 5-step Likert scale from (-2) Much worse to (+2) Much better | 12 months |
| Grip strength | Grip strength is measured with a dynamometer in kg as the mean of three measurements. It will be numbered in kg and percentage of the unaffected side | 12 months |
| Wrist range of motion (ROM) | Wrist ROM is measured on both wrists with a handheld goniometer in degrees. | 12 months |
| Complications | Incidence of complications (i.e. non-union, fracture, reoperation, infection, hematoma, iatrogenic tendon/nerve/arterial injury, complex regional pain syndrome) is recorded and compared between study groups. | 12 months |
| Patient-rated Quality of Life (EQ-5D) | 12 months |
| Cost-effectiveness | Quality-adjusted life years/months measured as a change in EQ-5D | 12 months |
| Central Hospital of Central Finland | Not yet recruiting | Jyväskylä | Finland |
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| Kymenlaakso Central Hospital | Not yet recruiting | Kotka | Finland |
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| Tampere University Hospital | Not yet recruiting | Tampere | Finland |
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| Turku University Hospital | Not yet recruiting | Turku | Finland |
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