Active, not recruiting
Observational
Zimmer POLAR Persona - TKA (EMEA Study)
Condition(s) studied
Severe Knee PainSevere Knee DisabilityOsteoarthritisRheumatoid ArthritisTraumatic ArthritisPolyarthritis
Investigational drug(s) / intervention(s)
Zimmer Persona Total Knee System
Zimmer Persona Total Knee System: No Intervention
Study summary
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:
1. Implant survivorship based on removal of a study device.
2. Safety based on incidence and frequency of adverse events.
3. Clinical performance measured by overall pain and function, quality of life data, radiographic parameters and survivorship.
Eligibility
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:
* rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis;
* collagen disorders and/or avascular necrosis of the femoral condyle;
* post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy;
* moderate valgus, varus, or flexion deformities;
* the salvage of previously failed surgical attempts that did not include partial or total knee arthroplasty of the ipsilateral knee.
* 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:
* Patient is currently participating in any other surgical intervention studies or pain management studies.
* Previous history of infection in the affected joint and/or other local/systemic infection that may affect the prosthetic joint.
* Insufficient bone stock on femoral or tibial surfaces.
* Skeletal immaturity.
* Neuropathic arthropathy.
* Osteoporosis or any loss of musculature or neuromuscular disease that compromises the affected limb.
* Stable, painless arthrodesis in a satisfactory functional position.
* Severe instability secondary to the absence of collateral ligament integrity.
* Rheumatoid arthritis accompanied by an ulcer of the skin or a history of recurrent breakdown of the skin.
* Patient has a known or suspected sensitivity or allergy to one or more of the implant materials.
* Patient is pregnant or considered a member of a protected population (e.g., prisoner, mentally incompetent, etc.).
* Patient has previously received partial or total knee arthroplasty for the ipsilateral knee.
Primary outcome measure(s)
- Kaplan-Meier Implant Survivorship — 5 years
Kaplan-Meier survivorship at 5 years with revision of any implant component, for any reason, as endpoint.
Trial sites (12)
| Facility | City | Region | Status |
| Orthopädisches Spital Speising |
Vienna |
Austria |
|
| CHU de Clermont-Ferrand |
Clermont-Ferrand |
France |
|
| Centre Hospitalier régional Universitaire de Montpellier |
Montpellier |
France |
|
| HEH Braunschweig |
Braunschweig |
Germany |
|
| Atos Klinik Heidelberg |
Heidelberg |
Germany |
|
| Stichting Research Orthopedie & Reinier de Graaf Groep |
Delft |
Netherlands |
|
| Hospital Parc Tauli |
Sabadell |
Spain |
|
| Hospital Miguel Servet |
Zaragoza |
Spain |
|
| University of Leeds |
Leeds |
Leeds/UK |
|
| Golden Jubilee National Hospital |
Clydebank |
United Kingdom |
|
| Harrogate and District NHS |
Harrogate |
United Kingdom |
|
| The Newcastle Upon Tyne Hospitals |
Newcastle |
United Kingdom |
|
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