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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 Origin Stem and Logical Acetabular Cup as part of 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 Origin Stem and Logical Cup when used for primary total hip arthroplasty at 2 years follow-up. This prospective follow-up series is necessary to obtain data specific to the Origin Stem and Logical Cup considering their relatively recent launch to the market.
The study includes pre-operative, operative, discharge, 1 year post-operative and 2 year post-operative evaluations, where data concerning the performance and safety of the device are gathered. In particular, 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 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 |
|---|---|---|---|---|
| Origin Stem and Logical Cup | Device | The Origin Stem is a straight, tapered, HA coated cementless femoral stem, and the Logical Cup is a porous coated acetabular cup mated with a cross-linked polyethylene liner. The components are used as part of a total joint replacement prosthesis. |
| Measure | Description | Time Frame |
|---|---|---|
| Stem and Cup Survival Rate | The implant survival rate 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, consisting of 12 questions scored 1 to 5 by the patient. | up to 2 years |
| Radiographic Analysis |
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Inclusion Criteria:
Exclusion Criteria:
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Patients of the Cleveland Clinic
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Melody C Labrune, MS | Contact | +61 02 9428 5181 | melody.labrune@signatureortho.com.au | |
| Declan Brazil, PhD | Contact | +61 02 9428 5181 | declan@signatureortho.com.au |
| Name | Affiliation | Role |
|---|---|---|
| Atul Kamath, 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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Post-operative radiographs of the implant are analysed to identify locations and sizes of radiolucencies, indicative of poor fixation. The size, location and progression of radiolucencies is monitored. Smaller, non-progressive radiolucencies are preferred.
| up to 2 years |