Clinical trial NCT02255383: Persona Total Knee Arthroplasty Outcomes Study
Official title: Persona The Personalized Knee System TKA Outcomes Study: Prospective Multicenter Study of the Persona Knee System
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
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
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2014-10-02
Enrollment: 737
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Knee Society Score
timeFrame: 10 years
Secondary outcomes:
measure: EQ-5D
timeFrame: 10 years
Other outcomes:
Locations:
city: Denver
country: United States
facility: Colorado Joint Replacement
state: Colorado
city: Fort Collins
country: United States
facility: Orthopaedic & Spine Center of the Rockies
state: Colorado
city: Parker
country: United States
facility: Denver-Vail Orthopedics
state: Colorado
city: Rockford
country: United States
facility: Rockford Orthopedic Associates
state: Illinois
city: New Castle
country: United States
facility: Henry County Orthopedics and Sports Medicine
state: Indiana
city: Chapel Hill
country: United States
facility: UNC Department of Orthopaedics
state: North Carolina
city: Charlotte
country: United States
facility: OrthoCarolina
state: North Carolina
city: Raleigh
country: United States
facility: Raleigh Orthopaedic Clinic
state: North Carolina
city: Cincinnati
country: United States
facility: Lindner Research Center
state: Ohio
city: Columbus
country: United States
facility: SportsMedicine Grant & Orthopaedic Associates
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Knoxville
country: United States
facility: Tennessee Orthopaedic Foundation for Education and Research
state: Tennessee
city: Lubbock
country: United States
facility: Texas Tech University Health Sciences Center
state: Texas
city: Virginia Beach
country: United States
facility: Jordan Young Institute
state: Virginia
Study officials:
affiliation: Zimmer Biomet
name: Kacy Arnold, RN, MBA
role: STUDY_DIRECTOR
References: