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Business Decision
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Five and ten year results of the CMK21 Hip system
This study is being conducted to collect long term retrospective and prospective clinical and radiological data to evaluate the safety of revision rate and adverse events, and efficacy of clinical and patient assessment of the CMK21 hip stem in primary total hip arthroplasty.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CMK21 Hip system | Device | Total hip arthroplasty |
| Measure | Description | Time Frame |
|---|---|---|
| Implant revision rate | Listing of implant status at 5 years to analyse the survival rate | 5 years |
| Implant revision rate | Listing of implants status at 10 years to analyse the survival rate | 10 years |
| Device related adverse events | Medical chart will be reviewed and device related events collected to monitor the safety | 10 years |
| Device related adverse events | Device related adverse events will be collected to monitor the safety | 5 and 10 years |
| Radiographic assessment | Radiolucent lines and radiosclerotic lines at both the bone cement and cement prosthesis interface | 5 and 10 Years |
| Radiographic assessment | Position and fixation of the components | 5 and 10 Years |
| Radiographic assessment | the occurrence of osteolysis | 5 and 10 Years |
| Radiographic assessment | the occurrence of heterotopic bone formation | 5 and 10 Years |
| Measure | Description | Time Frame |
|---|---|---|
| Harris Hip Score (HHS) | Harris Hip Score is a clinical evaluation which consists of a maximum of 100 points (best possible outcome) covering pain (1 item, 44 points), function (7 items 47 points total), absence of deformity (1 item, 4 points), and range of motion (2 items, 5 points total). | 5 and 10 years |
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Inclusion:
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The study population consists of all patients who received a CMK21 hip stem as part of a primary total hip arthroplasty between 2005 and 2007. This includes all diagnoses, all ages, male and female.
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| Name | Affiliation | Role |
|---|---|---|
| Beate Hanson, VP, PhD | Vice President, Global Clinical Strategy | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novellas Healthcare | Asse | Belgium | ||||
| Associatie Orthopedie Hasselt |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| Radiographic assessment | the occurrence of atrophy or hypertrophy | 5 and 10 Years |
| Radiographic assessment | the occurrence of cement tears/fractures | 5 and 10 Years |
| EuroQoL Five Dimensions Questionnaire (EQ-5D) |
The EuroQoL Five Dimensions Questionnaire is a subject self-assessment of quality of life and consists of five questions covering the dimensions of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The EQ-5D questionnaire also includes a Visual Analog Scale (VAS), by which subjects can report their perceived health status with a grade ranging from 0 (the worst possible health status) to 100 (the best possible health status). |
| 5 and 10 years |
| Hasselt |
| Belgium |