Austria, France, Germany777 participantsStarted 2013-11-18
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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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 satis…