Persona Total Knee Arthroplasty Outcomes Study

NCT02255383 | Active Not Recruiting

• 1 other identifier: CSU2014-02K
• Study Type: interventional
• Target: 737
• Locations: 1 country
• Sites: 14

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.

Conditions

Knee Pain Chronic; Osteoarthritis; Rheumatoid Arthritis; Traumatic Arthritis; Polyarthritis; Moderate Varus, Valgus or Flexion Deformities; Avascular Necrosis of the Femoral Condyle

Keywords

Osteoarthritis; Rheumatoid Arthritis; Traumatic Arthritis; Polyarthritis; Total Knee Arthroplasty

Outcome Measures

Primary Outcomes (1)

• Knee Society Score

  Knee Society Score

  10 years

Secondary Outcomes (1)

• EQ-5D

  10 years

Study Arms (1)

PERSONA TKA

OTHER

Primary total knee arthroplasty subjects that receive the Zimmer Persona Total Knee System

Device: Zimmer Persona Total Knee System

Interventions

Zimmer Persona Total Knee System DEVICE

Primary Total Knee Arthroplasty

Also known as: Total Knee Arthroplasty, Total Knee Replacement

PERSONA TKA

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (14)

Colorado Joint Replacement

Denver, Colorado, 80210, United States

Location

Orthopaedic & Spine Center of the Rockies

Fort Collins, Colorado, 80525, United States

Location

Denver-Vail Orthopedics

Parker, Colorado, 80134, United States

Location

Rockford Orthopedic Associates

Rockford, Illinois, 61114, United States

Location

Henry County Orthopedics and Sports Medicine

New Castle, Indiana, 47362, United States

Location

UNC Department of Orthopaedics

Chapel Hill, North Carolina, 27599-7055, United States

Location

OrthoCarolina

Charlotte, North Carolina, 28207, United States

Location

Raleigh Orthopaedic Clinic

Raleigh, North Carolina, 27612, United States

Location

Lindner Research Center

Cincinnati, Ohio, 45219, United States

Location

SportsMedicine Grant & Orthopaedic Associates

Columbus, Ohio, 43215, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Tennessee Orthopaedic Foundation for Education and Research

Knoxville, Tennessee, 37930, United States

Location

Texas Tech University Health Sciences Center

Lubbock, Texas, 79430, United States

Location

Jordan Young Institute

Virginia Beach, Virginia, 23462-1784, United States

Location

MeSH Terms

Conditions

Osteoarthritis; Arthritis, Rheumatoid; Arthritis; Genu Valgum

Interventions

Arthroplasty, Replacement, Knee

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Bone Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2014
• First Posted: October 2, 2014
• Study Start: July 1, 2014
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 10, 2026

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (14)