Everglade Stem, World Cup and World Liner Post Market Clinical Follow-up
Study Details
Study Description
Brief Summary
The aim of the Study is to monitor the performance of the Signature Orthopaedics Everglade Stem, World Acetabular Cup and World Liner as a part of post-market vigilance and continuous improvement efforts.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
The Objective of this Post market Clinical Follow up (PMCF) study is to collect data confirming safety, performance and clinical benefits of the Everglade Stem, World Acetabular Cup and World Liner when used for a primary total hip arthroplasty at 2 years follow-up.
This prospective follow-up series is necessary to gather data for the Everglade Stem, World Acetabular Cup and World Liner as they are recently launched to the market.
The data concerning the performance and safety of the devices are gathered in various time frames starting with pre-operative status and then includes operative, at discharge, i year post-operative and 2 year post-operative evaluations.
The revision rate of the components will be monitored as the primary objective, along with pre- and post-operative measurement of the Oxford Hip Score(OHS) patient-reported outcome measure(PROM) to quantify patient satisfaction and radiographic analysis to monitor the bony response to the implants and quantify the effectiveness of the cementless fixation.
Study Design
Outcome Measures
Primary Outcome Measures
- Everglade Stem, World Cup and World Liner Survival Rate [upto 2 years]
The implant survival rate based on removal of the device for any reason as determined following the Kaplan-Meier method
Secondary Outcome Measures
- Oxford Hip Score (OHS) [up to 2 years]
The OHS is a patient reported outcome measure (PROM) used to quantify patient satisfaction with the treatment. The OHS consists of 12 questions scored 1 to 5 by the patient.
Other Outcome Measures
- Radiographic Analysis [up to 2 years.]
Post-operative radiographs of the implant are analysed to identify locations and sizes of radiolucency, indicative of poor fixation. The size, location and progression of radiolucencies is monitored. Smaller, non-progressive radiolucencies are preferred.
Eligibility Criteria
Criteria
Inclusion Criteria:
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patient requires unilateral primary total hip arthroplasty due to non-inflammatory degenerative joint disease (e.g. osteoarthritis, traumatic arthritis, avascular necrosis, dysplasia/DDH)
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patient must be a candidate for use of the products studied, as determined jointly by the surgeon and patient
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male and non-pregnant female patients aged 18-75
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patients who understand the conditions of the clinical evaluation and are willing to participate for the length of the prescribed follow-up
Exclusion Criteria:
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patient has active infection or sepsis(treated or untreated) enough to compromise implant stability or postoperative recovery
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patient is a female of child-bearing age and not taking and not taking contraceptive pills
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patient has inadequate bone stock to support the device (e.g. severe osteopenia, family history of severe osteoporosis or osteopenia)
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patient has a known or suspected metal sensitivity
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patient is immuno-suppressed with disease such as AIDS or is receiving high dose of cortico-steroids.
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patient has an emotional or neurological condition that would pre-empt their ability or unwillingness to participate in the clinical evaluation including mental illness, mental retardation or drug abuse
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patient is severely overweight with a BMI>40.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cleveland Clinic | Cleveland | Ohio | United States | 44195 |
Sponsors and Collaborators
- Signature Orthopaedics
- The Cleveland Clinic
Investigators
- Principal Investigator: Nicolas Piuzzi, MD, The Cleveland Clinic
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 111-450-100