degeneratieve zoals Arthritis NVT
Conditions
Interventions
see 9 e b f h
Sponsors
Mediqol
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Subject between 35 and 65 years of age. Unicompartimental desease of one knee due to osteoarthritis or injury. Body mass index
Exclusion criteria
Exclusion criteria: Generilized disease of bone, including osteoporosis, hyper-or hypo- parathyroidism, Pagets disease of bone, or other metabolic bone disease. Known presence of any disaese which may affect bone metabolism. history of alcohol or drug abuse. Moderate to severe restricted physical activity. Any Physical or mental state that would preclude ability to abide by study criteria. Diagnosed with severe rheumatoid arthritis, systemic inflammatory arthritis, chondral or bone dysplasias, deformities of the hip or severe osteoarthritis of the spine. History of malignant disease within 5 years, except for basal cell and squamous cell carcinoma of the skin.. The subject is pregnant or will become pregnant during the study or has any other condition that would preclude having X-Rays.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All baseline demographic, presenting conditions and medical history data will be tabulated. Analysis for safety and performance will be done by subgroup analysis or covariate analysis. The primary hypothesis of decrease in pain and increased knee function will be tested by the test of independent proportions using Fisher's Exact test for 2x2 tables when possible, or chi squared test where the approximation is justifiable. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary hypotheses will be tested also with the Fisher Exact 2x2 analysis for acute success rates, and for the occurrence rates of adverse events and other safety measures. For quantitative measures such as pain and function, these will be analyzed using appropriate nonparametric methods such as the Mann-Whitney test. Any experienced procedural complications or other adverse events will be tabulated and presented Beyond these comparisons, sophisticated statistical models may be used to confirm and explore unique advantages of the ConforMIS* system. These tests may include, but may not be limited to, multivariate regression, failure time model analysis, decision analysis. In addition cost-effectiveness analysis may be done where data is available. | — |
Countries
Netherlands
Outcome results
None listed