Persona Total Knee Arthroplasty Outcomes Study

Not Applicable

Active, not recruiting

• Conditions: Knee Pain Chronic; Traumatic Arthritis; Polyarthritis; Moderate Varus, Valgus or Flexion Deformities; Avascular Necrosis of the Femoral Condyle; Osteoarthritis; Rheumatoid Arthritis
• Interventions: Device: Zimmer Persona Total Knee System

• Registration Number: NCT02255383
• Lead Sponsor: Zimmer Biomet

Brief Summary

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.

Detailed 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 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, 5, 7, and 10 years.

The primary objective of this study is to obtain implant survivorship and clinical outcomes data for the commercially available Persona fixed bearing implants used in primary total knee arthroplasty. The assessments will include: implant survivorship based on removal of a study device; safety based on incidence and frequency of adverse events; and clinical performance measured by overall pain and function, quality of life data, radiographic parameters and survivorship.

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-09-29
• Study First Submitted QC: 2014-10-01
• Study First Posted: 2014-10-02
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-12
• Last Update Posted: 2024-11-14
• Primary Completion: 2025-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 737

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PERSONA TKA	Zimmer Persona Total Knee System	Primary total knee arthroplasty subjects that receive the Zimmer Persona Total Knee System

Primary Outcome Measures

Name	Time	Method
Knee Society Score	10 years	Knee Society Score

Secondary Outcome Measures

Name	Time	Method
EQ-5D	10 years	EQ-5D

Trial Locations

Locations (14)

SportsMedicine Grant & Orthopaedic Associates; 🇺🇸 Columbus, Ohio, United States

Orthopaedic & Spine Center of the Rockies; 🇺🇸 Fort Collins, Colorado, United States

Denver-Vail Orthopedics; 🇺🇸 Parker, Colorado, United States

Rockford Orthopedic Associates; 🇺🇸 Rockford, Illinois, United States

Henry County Orthopedics and Sports Medicine; 🇺🇸 New Castle, Indiana, United States

Raleigh Orthopaedic Clinic; 🇺🇸 Raleigh, North Carolina, United States

OrthoCarolina; 🇺🇸 Charlotte, North Carolina, United States

Lindner Research Center; 🇺🇸 Cincinnati, Ohio, United States

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Tennessee Orthopaedic Foundation for Education and Research; 🇺🇸 Knoxville, Tennessee, United States

Texas Tech University Health Sciences Center; 🇺🇸 Lubbock, Texas, United States

Jordan Young Institute; 🇺🇸 Virginia Beach, Virginia, United States

Colorado Joint Replacement; 🇺🇸 Denver, Colorado, United States

UNC Department of Orthopaedics; 🇺🇸 Chapel Hill, North Carolina, United States