NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

Persona Total Knee Arthroplasty Outcomes Study

Active Not RecruitingNA

Sponsor: Zimmer Biomet

Conditions: Knee Pain Chronic, Osteoarthritis, Rheumatoid Arthritis, Traumatic Arthritis, Polyarthritis

Interventions: Zimmer Persona Total Knee System

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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: a) rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis; b) collagen disorders and/or avascular necrosis of the femoral condyle; c) post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy; d) moderate valgus, varus, or flexion deformities; or e) 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 provide written Informed Consent by signing and dating the IRB or EC approved Informed Consent Form
* 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

Locations (14)

Denver, Colorado, United States
Fort Collins, Colorado, United States
Parker, Colorado, United States
Rockford, Illinois, United States
New Castle, Indiana, United States
Chapel Hill, North Carolina, United States
Charlotte, North Carolina, United States
Raleigh, North Carolina, United States
Cincinnati, Ohio, United States
Columbus, Ohio, United States
Philadelphia, Pennsylvania, United States
Knoxville, Tennessee, United States
Lubbock, Texas, United States
Virginia Beach, Virginia, United States