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Problems with recruiting patients.
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| Name | Class |
|---|---|
| Central Finland Hospital District | OTHER |
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A prospective, randomised controlled trial where clinical and radiological outcome of high tibial opening wedge osteotomy with physiotherapy is compared to physiotherapy alone while treating symptomatic medial knee osteoarthrosis.
90 Symptomatic patients with mild to moderate medial knee osteoarthrosis are randomized to two groups:
Group 1 (HTO-group) receive an diagnostic arthroscopy with high tibial opening wedge osteotomy (Tomofix-plate). Postoperatively a supervised physiotherapeutic rehabilitation program is started.
Group 2 (FT-group) receive the same supervised physiotherapeutic rehabilitation program without the HTO or arthroscopy.
Primary outcome measure is composite score of Knee injury and Osteoarthritis Outcome Score (KOOS5).
Secondary outcome measures are pain (VAS), KOOS subscales, objective physical performance measurements, progression of osteoarthrosis (X-ray, MRI), change of mechanical axis, complications, treatment costs, rate of reoperation, revision to total knee arthroplasty (TKA), biological markers of arthrosis progression, 15D (quality of life assessment), QALY (Quality-Adjusted Life-Year), Work Productivity and Activity Impairment Questionnaire, Work Productivity and Activity Impairment Questionnaire, sum of governmental benefits received.
Outcomes will be measured at 24, 60 and 120 months after the intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HTO-group | Active Comparator | Group receives opening wedge high tibial osteotomy with Tomofix -plate. Operative intervention is followed by supervised physiotherapeutic rehabilitation. |
|
| FT -group | Active Comparator | Group receives only supervised physiotherapeutic rehabilitation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HTO | Procedure | Group that receives high tibial osteotomy combined with supervised physiotherapy as treatment. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change of KOOS5 | The change of Composite score of Knee injury and Osteoarthritis Outcome Score (KOOS) subscales | 24, 60, 120 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change of pain measured in numeric rated scale (NRS) | Amount of subjective (knee) pain | 24, 60, 120 months |
| Change of KOOS subscales | Individual subscales of Knee injury and Osteoarthritis Outcome Scores |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jussi Jalkanen, M.D. | Kuopio University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Kuopio | Kuopio | Finland |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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Prospective randomized controlled trial.
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The clinical assessors are blinded when applicable.
| Supervised physiotherapeutic program | Other | Group that receives only supervised physiotherapy as treatment. |
|
| 24, 60, 120 months |
| Change in results of 40 meter fast paced walk test | A fast-paced walking test that is timed over 4 x 10m (33 ft) for a total 40 m (132 ft) | 24, 60, 120 months |
| Change in results of stair climb test | The time (in seconds) it takes to ascend and descend a flight of stairs | 24, 60, 120 months |
| Change in results of timed up and go test | Time (seconds) taken to rise from a chair, walk 3 m, turn, walk back to the chair, then sit down wearing regular footwear and using a walking aid if required. | 24, 60, 120 months |
| Radiological progression of arthrosis | x-ray, MRI | 24, 60, 120 months |
| Change in mechanical axis of lower limb | As measured from whole leg standing radiograph | 12, 24, 60, 120 months |
| Incidence of complications | eg infection, non-union, thromboembolic complications etc. | Up to 120 months |
| Total costs of treatment | Including the cost of hospital treatment, physiotherapy, cost of medication, cost of sick leave | Up to 120 months |
| Incidence of reoperation | Amount of reoperations needed | Up to 120 months |
| Hyaluronic acid (HA) concentration | At 24, 60 and 120 month follow-up blood and synovial fluid samples are analyzed for HA concentration. This will be measured with antibody-ELISA at mg/g from 10µl of fluid. The same measurement will be conducted on blood serum. | 24, 60, 120 months |
| Fatty acid (FA) profiling | At 24, 60 and 120 month follow-up blood and synovial fluid samples are analyzed for fatty acid (FA) profiling. FA will be analyzed from 75 µl of synovial fluid and 200 µl of blood serum with gas chromatography as mol-%. | 24, 60, 120 months |
| Synovial fluid composition | At 24, 60 and 120 month follow-up synovial fluid samples are analyzed for composition. Synovial fluid composition will be assessed visually with confocal microscopy with a HA-biding fluorescent probe and Nile red probe that show both HA particles and the association of these particles on extracellular vesicles to assess the significance of vesicle-mediated HA secretion into synovial fluid. | 24, 60, 120 months |
| General variables reflecting inflammatory status | At 24, 60 and 120 month follow-up blood and blood serum samples are analyzed for general variables reflecting inflammatory status (leucocytes, C-reactive protein, IL-6). | 24, 60, 120 months |
| 15D -quality of life assessement | The change of health-related quality of life (HRQoL) instrument | 24, 60, 120 months |
| Work Productivity and Activity Impairment Questionnaire (WPAI) | The change of WPAI | 24, 60, 120 months |
| Amount of national benefits received | The amount of benefits are gathered from:
| Up to 120 months |