Zimmer POLAR - Total Knee Arthroplasty (TKA)
This trial is active, not recruiting.
|Conditions||osteoarthritis, rheumatoid arthritis, traumatic arthritis, polyarthritis|
|Treatment||zimmer persona total knee system|
|Start date||April 2013|
|End date||June 2018|
|Trial size||300 participants|
|Trial identifier||NCT01859130, CSU2012-10K|
The primary objective of this study is to obtain implant survivorship and clinical outcomes data for commercially available Persona fixed bearing knee implants used in total knee arthroplasty. The assessment will include implant survivorship and clinical performance measured by pain and function, quality of life data, radiographic parameters and survivorship.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Winfield, IL||Central DuPage Hospital||no longer recruiting|
|Egg Harbor Township, NJ||The Rothman Institute||no longer recruiting|
|Durham, NC||Duke University||no longer recruiting|
|Philadelphia, PA||The Rothman Institute||no longer recruiting|
|Intervention model||single group assignment|
Primary total knee arthroplasty subjects that receive the Zimmer Persona Total Knee System
Knee Society Scores
time frame: 5 years post op
time frame: 5 years post op
Male or female participants from 18 years up to 75 years old.
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 has participated in a study-related Informed Consent process; - 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 Persona fixed bearing knee components 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.
|Official title||Persona Outcomes Led Assessment Research in Total Knee Arthroplasty|
|Description||The study design is a prospective, multicenter, study of the commercially available Persona fixed bearing knee implants. The study will require each site to obtain Institutional Review Board (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 total knee arthroplasty. The post-operative clinical and radiographic evaluations will be conducted at 6 weeks, 6 months, 1 year, 2, 3, 4, and 5 years.|
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