Clinical trial NCT04461626: Prospective Multi-centre Outcomes Study of Persona Knee System in Total Knee Arthroplasty
Official title: Prospective Multi-centre Outcomes Study of Persona Knee System in Total Knee Arthroplasty
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Knee Osteoarthritis
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2020-07-08
Enrollment: 1017
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will consist of patients who require primary TKA and satisfy eligible criteria outlined in this section. In order to avoid potential selection bias, each investigator will offer study participation to each consecutive eligible patient presenting as a candidate for primary TKA using the Persona fixed bearing knee system.

Brief summary: This is a prospective, multi-centre, non comparative, post market clinical follow-up study involving orthopaedic surgeons skilled in TKA and experienced implanting the devices included in this study.

Detailed description: The objectives of the study are to document the implant survivorship and clinical outcomes data for the Persona fixed bearing implants used in primary total knee arthroplasty (TKA). The study will include a maximum of 20 centres and up to 1000 implanted knees. Each centre may enrol up to a maximum of 100 implanted knees to permit assessment of the consistency of outcomes across a variety of investigators and clinical settings.

Eligibility criteria: Inclusion Criteria:

* Age 18 to 80 years old, inclusive
* Qualifies for a primary TKA based on physical exam and medical history, including diagnosis of severe knee pain and disability due to at least one of the following:

  1. Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
  2. Collagen disorders and/ or avascular necrosis of femoral condyle.
  3. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.
  4. Moderate valgus, varus or flexion deformities.
  5. The salvage of previously failed surgical attempts that did not include partial or total knee arthroplasty of the ipsilateral knee.
* Participated in a study-related informed consent process.
* Willing and able to provide written informed consent by signing and dating the IRB/EC approved informed consent form.
* 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 system implanted in accordance with product labelling.

Exclusion Criteria:

* 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
* 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.
* Known or suspected sensitivity or allergy to one or more of the implant materials.
* Pregnant or considered a member of a protected population (e.g. prisoner, mentally incompetent, etc.)
* Previously received partial or total knee arthroplasty for the ipsilateral knee.

Primary outcomes:
measure: Implant Survivorship
timeFrame: Up to 5 years post surgery
measure: Adverse Events (Safety)
timeFrame: Up to 5 years post surgery
measure: Clinical Performance
timeFrame: Up to 5 years post surgery
measure: Clinical Performance
timeFrame: Up to 5 years post surgery
Secondary outcomes:
Other outcomes:
Locations:
city: West Perth
country: Australia
facility: Fremantle Hospital
city: Bangalore
country: India
facility: Fortis Health Care, Bangalore
city: Delhi
country: India
facility: Sant Parmanand Hospital
city: Delhi
country: India
facility: All India Institute of Medical Sciences
city: Hyderabad
country: India
facility: Landmark Hospitals
city: Pune
country: India
facility: Deenanath Mangeshkar Hospital
city: Kochi
country: Japan
facility: Kochi University Hospital
city: Tokyo
country: Japan
facility: Nihon University Hospital
city: Gangneung
country: Korea, Republic of
facility: GangNeung Asan Hospital
city: Hwasun
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
city: Seoul
country: Korea, Republic of
facility: Chungang University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul Asan Medical Center
city: Yangsan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
city: Hamilton
country: New Zealand
facility: Waikato Hospital
state: Waikato
city: Singapore
country: Singapore
facility: Singapore General Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Myung Chul Lee
role: PRINCIPAL_INVESTIGATOR
References: