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| Name | Class |
|---|---|
| The Cleveland Clinic | OTHER |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment | Device | The Evergladeâ„¢ Stem, is a second generation cementless blade style hip stem Forged in Titanium and proximally Antero-Posterior (AP) flared with Titanium Plasma Spray + Hydroxyapatite (TPS + HA) coated for bone on-growth. The stem has distal geometry and a polished anodized surface finish to minimize the stem hanging in Dorr A femurs. The World Acetabular Cup is a porous coated and mated with the Cross-linked polyethylene World Liner |
| Measure | Description | Time Frame |
|---|---|---|
| Everglade Stem, World Cup and World Liner Survival Rate | The implant survival rate based on removal of the device for any reason as determined following the Kaplan-Meier method | upto 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Oxford Hip Score (OHS) | 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. | up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Radiographic Analysis | 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. | up to 2 years. |
Inclusion Criteria:
Exclusion Criteria:
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Patients of the Cleveland Clinic
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Satish A Shejale, M.S. Orthopaedics | Contact | +61 02 9428 5181 | satish.shejale@signatureortho.com.au | |
| Declan Brazil, PhD | Contact | +61 02 9428 5181 | declan@signatureortho.com.au |
| Name | Affiliation | Role |
|---|---|---|
| Nicolas Piuzzi, MD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Recruiting | Cleveland | Ohio | 44195 | United States |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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