Persona Total Knee Arthroplasty Outcomes Study

Rheumatoid Arthritis Clinical Trial

Official title:

Persona The Personalized Knee System TKA Outcomes Study: Prospective Multicenter Study of the Persona Knee System

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02255383
• Other study ID #: CSU2014-02K
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 2014
• Est. completion date: December 2027

Study information

• Verified date: August 2023
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 737
• Est. completion date: December 2027
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• Zimmer Persona Total Knee System
Primary Total Knee Arthroplasty

Locations

Country	Name	City	State
United States	UNC Department of Orthopaedics	Chapel Hill	North Carolina
United States	OrthoCarolina	Charlotte	North Carolina
United States	Lindner Research Center	Cincinnati	Ohio
United States	SportsMedicine Grant & Orthopaedic Associates	Columbus	Ohio
United States	Colorado Joint Replacement	Denver	Colorado
United States	Orthopaedic & Spine Center of the Rockies	Fort Collins	Colorado
United States	Tennessee Orthopaedic Foundation for Education and Research	Knoxville	Tennessee
United States	Texas Tech University Health Sciences Center	Lubbock	Texas
United States	Henry County Orthopedics and Sports Medicine	New Castle	Indiana
United States	Denver-Vail Orthopedics	Parker	Colorado
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Raleigh Orthopaedic Clinic	Raleigh	North Carolina
United States	Rockford Orthopedic Associates	Rockford	Illinois
United States	Jordan Young Institute	Virginia Beach	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knee Society Score	Knee Society Score	10 years
Secondary	EQ-5D	EQ-5D	10 years