Osteoarthritis
Conditions
Keywords
hip prosthesis
Brief summary
Five and ten year results of the CMK21 Hip system
Detailed description
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.
Interventions
DEVICECMK21 Hip system
Total hip arthroplasty
Sponsors
Smith & Nephew, Inc.
Study design
Observational model
OTHER
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
Inclusion: * The patients enrolled in the study were already operated at the time of the screening. * All the patients with osteoarthritis of the hip who received CMK21 hip stem between 2005 and 2007. * Skeletally mature patients requiring primary total hip arthroplasty due to non-inflammatory arthritis (degenerative joint disease) such as osteoarthritis, avascular necrosis, or traumatic arthritis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Implant revision rate | 5 years | Listing of implant status at 5 years to analyse the survival rate |
| Device related adverse events | 10 years | Medical chart will be reviewed and device related events collected to monitor the safety |
| Radiographic assessment | 5 and 10 Years | Radiolucent lines and radiosclerotic lines at both the bone cement and cement prosthesis interface |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Harris Hip Score (HHS) | 5 and 10 years | 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). |
| EuroQoL Five Dimensions Questionnaire (EQ-5D) | 5 and 10 years | 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). |
Countries
Belgium
Outcome results
None listed