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The primary objective of this study is to obtain implant survivorship and clinical outcomes data for the commercially available Persona Partial Knee System.
The study design is a prospective, multicenter, noncontrolled study of the commercially available Persona Partial Knee. The study will require each site to obtain IRB approval prior to study enrollment. All potential study subjects will be required to participate in the Informed Consent Process.
All study subjects will undergo preoperative clinical evaluations prior to their partial knee arthroplasty. Investigators will collect clinical data for a required 2 years with the option to continue follow-up assessment up to 10 years. Follow-up clinical visits include 3 months, 1 year, 2, 5, and 10 years post-operatively.
The primary objective of this study is to obtain implant survivorship and clinical outcomes data for the commercially available Persona Partial Knee System. The assessments will include: implant survivorship based on revision with removal of the study device; safety based on incidence and frequency of adverse events; and clinical performance measured by overall pain and function, quality of life data, radiographic parameters, and survivorship.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PPK subjects | Other | Subjects that receive the Persona Partial Knee system |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Persona Partial Knee system | Device | Fixed bearing partial knee |
|
| Measure | Description | Time Frame |
|---|---|---|
| Oxford Knee Score | A Patient reported functional outcome score for knee arthroplasty | 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| EQ-5D | a questionnaire completed by the Patient and assesses his/her General health Status. The EQ5D is used to derive a Quality of life index used for health economics considerations. | 10 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hillary Overholser | Zimmer Biomet | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sah Orthopaedic Associates | Fremont | California | 94538 | United States | ||
| Panorama Orthopedics & Spine Center |
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| Golden |
| Colorado |
| 80401 |
| United States |
| Midwest Orthopaedics at Rush | Chicago | Illinois | 60612 | United States |
| Henry County Orthopedics and Sports Medicine | New Castle | Indiana | 47362 | United States |
| Sports Medicine North | Beverly | Massachusetts | 01960 | United States |
| Troy Orthopaedic Associates | Troy | Michigan | 48084 | United States |
| New Mexico Orthopaedics | Albuquerque | New Mexico | 87106 | United States |
| Midlands Orthopaedics & Neurosurgery | Columbia | South Carolina | 29201 | United States |
| Skagit Regional Clinics-Riverbend | Mount Vernon | Washington | 98273 | United States |
| Orthopädisches Spital Speising | Vienna | Austria |
| Cliniques Universitaires Saint-Luc | Woluwe-Saint-Lambert | Belgium |
| Marseille University-Hospital Centres | Marseille | France |
| Public Hospital of Versailles | Versailles | France |
| Hessing Stiftung | Augsburg | Germany |
| Sana Kliniken Sommerfeld | Berlin | Germany |
| Waldkrankenhaus Eisenberg | Eisenberg | Germany |
| Orthopedic Institute IRCCS | Milan | Italy |
| Fondazione IRCCS Policlinico San Matteo | Pavia | Italy |
| Hospital Alcorcón | Madrid | Spain |
| Umea University Hospital | Umeå | Sweden |
| Hopital d'Yverdon les Bains | Yverdon-les-Bains | Switzerland |
| Avon Orthopaedic Centre, Southmead Hospital | Bristol | United Kingdom |
| Royal Derby Hospital | Derby | United Kingdom |
| Harrogate and District NHS Foundation Trust | Harrogate | United Kingdom |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D010020 | Osteonecrosis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D001847 | Bone Diseases |
| D009336 | Necrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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