Five and Ten Year Results of the CMK21 Hip System

Study Overview
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Brief Summary
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Five and ten year results of the CMK21 Hip system

Detailed Description
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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.

Official Title
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Five and Ten Year Results of the CMK21 Hip System

Conditions
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Osteoarthritis

Intervention / Treatment
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* Device: CMK21 Hip system


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: CMK21 Hip system|Total hip arthroplasty|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 
| Radiographic assessment | the occurrence of atrophy or hypertrophy | 5 and 10 Years | 
| Radiographic assessment | the occurrence of cement tears/fractures | 5 and 10 Years | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hip prosthesis