Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The primary objective of this study is to obtain implant survivorship and clinical outcomes data for commercially available Persona knee implants used in primary total knee arthroplasty. The assessment will include:
This is a prospective, multicenter, non-controlled study of the commercially available Persona knee implants. The study will require each site to obtain Ethics approval prior to study enrollment. All potential study subjects will be required to participate in the Informed Consent Process.
Study subjects will undergo preoperative clinical evaluations prior to their total knee arthroplasty. The post-operative clinical and radiographic evaluations will be conducted at 5 days to 6 weeks, 3 to 6 months, 1 year, 2, 3, 4, and 5 years after implantation. The hospital CHU Clermont-Ferrand, France with PI Prof. Boisgard will conduct additional 7 (voluntary) and 10 years (standard of care) follow-up visits.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zimmer Persona Total Knee System | Device | No Intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| Kaplan-Meier Implant Survivorship | Kaplan-Meier survivorship at 5 years with revision of any implant component, for any reason, as endpoint. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| 'Knee injury and Osteoarthritis Outcome Score' (KOOS) subscale scores. | The scores related to the five KOOS subscales calculated at different time points until 5 years. | 5 years |
| 'Forgotten Joint Score' (FJS-12) |
Not provided
Inclusion Criteria:
Patient 18-75 years of age, inclusive.
Patient qualifies for primary total knee arthroplasty based on physical exam and medical history, including diagnosis of severe knee pain and disability due to at least one of the following:
Patient is willing and able to complete scheduled study procedures and follow-up evaluations.
Independent of study participation, patient is a candidate for commercially available Zimmer Persona knee implants implanted in accordance with product labeling.
Exclusion Criteria:
Not provided
Not provided
Primary total knee arthroplasty subjects that receive the Zimmer Persona Total Knee System.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Martin Dominkus, MD | Orthopädisches Spital Speising, Wien, Austria | Principal Investigator |
| Hendrik Verburg, MD | Stichting Research Orthopedie & Reinier de Graaf Groep, Delf, Netherlands | Principal Investigator |
| Nicholas London, MD | Harrogate and District NHS, Harrogate, England | Principal Investigator |
| Stéphane Boisgard, MD | CHU de Clermont-Ferrand, Clermont-Ferrand, France | Principal Investigator |
| François Canovas, Prof | Hospital Lapeyronie, Montpellier | Principal Investigator |
| Pere Torner, MD | Hospital Parc Tauli, Sabadell | Principal Investigator |
| Jon Clarke, MD | Golden Jubilee National Hospital, Clydebank | Principal Investigator |
| David Deehan, Prof | Freeman Hospital, Newcastle | Principal Investigator |
| Karl Dieter Heller, Prof | HEH Braunschweig |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orthopädisches Spital Speising | Vienna | 1130 | Austria | |||
| CHU de Clermont-Ferrand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30832636 | Derived | Mathijssen NMC, Verburg H, London NJ, Landsiedl M, Dominkus M. Patient reported outcomes and implant survivorship after Total knee arthroplasty with the persona knee implant system: two year follow up. BMC Musculoskelet Disord. 2019 Mar 4;20(1):97. doi: 10.1186/s12891-019-2470-y. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The score related to the FJS-12 patient-reported questionaire calculated at different time points until 5 years.
| 5 years |
| Oxford Knee Score (OKS) | The score related to the OKS patient-reported questionaire calculated at different time points until 5 years. | 5 years |
| EuroQol (EQ)-5D-3L score and EQ 'Visual Analog Scale' (VAS) | The scores related to the EQ-5D-3L questionnaire and the EQ-VAS calculated at different time points until 5 years. | 5 years |
| Fritz Thorey, Prof | Atos Klinik Heidelberg | Principal Investigator |
| Fernando Martinez Delgado, MD | Hospital Miguel Servet Zaragoza | Principal Investigator |
| Hermant Pandit, Prof | University of Leeds | Principal Investigator |
| Clermont-Ferrand |
| 63003 |
| France |
| Centre Hospitalier régional Universitaire de Montpellier | Montpellier | 34980 | France |
| HEH Braunschweig | Braunschweig | Germany |
| Atos Klinik Heidelberg | Heidelberg | Germany |
| Stichting Research Orthopedie & Reinier de Graaf Groep | Delft | 2612 | Netherlands |
| Hospital Parc Tauli | Sabadell | Spain |
| Hospital Miguel Servet | Zaragoza | Spain |
| University of Leeds | Leeds | Leeds/UK | LS2 9JT | United Kingdom |
| Golden Jubilee National Hospital | Clydebank | United Kingdom |
| Harrogate and District NHS | Harrogate | HG2 7SX | United Kingdom |
| The Newcastle Upon Tyne Hospitals | Newcastle | United Kingdom |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001172 | Arthritis, Rheumatoid |
| D001168 | Arthritis |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D019645 | Arthroplasty, Replacement, Knee |
| ID | Term |
|---|---|
| D019643 | Arthroplasty, Replacement |
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
| D019651 | Plastic Surgery Procedures |
| D019919 | Prosthesis Implantation |
Not provided
Not provided