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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 Spartan Stem, World Acetabular Cup and World Liner as a post-market vigilance and continuous improvement efforts.
The objective of this PMCF Study is to collect data confirming safety, performance and clinical benefits of the Spartan Stem, World Acetabular Cup and the World Liner when used for primary total hip arthroplasty at 2-years follow-up.
The study includes pre-operative, operative, discharge, 1 year post-operative evaluations, where data concerning the performance and safety of the device are gathered.
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.
Radiography analysis will be done to monitor bony response to the implant and qualify the effectiveness of the cementless fixation.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spartan Stem, World Acetabular Cup and World Liner | Device | The Spartan Stem is a wedge-shaped fit and fill design stem with Titanium Plasma Spray(TPS) and Hydroxyapatite (HA) coating. The World Acetabular cup is Porous coated and mated with cross-linked polyethylene World Liner |
| Measure | Description | Time Frame |
|---|---|---|
| Spartan Stem, World Acetabular Cup and World Liner Survival Rate | The implant survival rate is based on removal of the device for any reason as determined following the Kaplan-Meier method. | up to 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. It 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 radiolucency 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 Shejale, MS Ortho | 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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