PMS to evaluate the performance of the Conformis IPD knee in the NL.
- Conditions
- degeneratieve zoals ArthritisNVT10005944
- Registration Number
- NL-OMON30472
- Lead Sponsor
- Mediqol
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 40
Subject between 35 and 65 years of age. Unicompartimental desease of one knee due to osteoarthritis or injury. Body mass index < 35. Investigators are satisfied that there are no other physical conditions present which would prevent the patient from entering and completing the study. Patient is willing and able o return to the site of the investigation at the specified times and study intervals. The patient is willing to participate in the proposed study as evidence by signing an informed consent form. Subject is not participating in other clinical trials that would conflict with this protocol.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>All baseline demographic, presenting conditions and medical history data will<br /><br>be tabulated. Analysis for safety and performance will be done by subgroup<br /><br>analysis or covariate analysis. The primary hypothesis of decrease in pain and<br /><br>increased knee function will be tested by the test of independent proportions<br /><br>using Fisher's Exact test for 2x2 tables when possible, or chi squared test<br /><br>where the approximation is justifiable.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary hypotheses will be tested also with the Fisher Exact 2x2 analysis for<br /><br>acute success rates, and for the occurrence rates of adverse events and other<br /><br>safety measures. For quantitative measures such as pain and function, these<br /><br>will be analyzed using appropriate nonparametric methods such as the<br /><br>Mann-Whitney test. Any experienced procedural complications or other adverse<br /><br>events will be tabulated and presented<br /><br>Beyond these comparisons, sophisticated statistical models may be used to<br /><br>confirm and explore unique advantages of the ConforMIS* system. These tests may<br /><br>include, but may not be limited to, multivariate regression, failure time model<br /><br>analysis, decision analysis. In addition cost-effectiveness analysis may be<br /><br>done where data is available.</p><br>