Prospective Multi-centre Outcomes Study of Persona Knee System in Total Knee Arthroplasty

Knee Osteoarthritis Clinical Trial

Official title:

Prospective Multi-centre Outcomes Study of Persona Knee System in Total Knee Arthroplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04461626
• Other study ID #: CSA2014-02K
• Status: Completed
• Start date: November 19, 2014
• Est. completion date: June 30, 2023

Study information

• Verified date: August 2022
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1017
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• Persona fixed bearing knee system (All patients will receive Persona fixed bearing knee system)

Locations

Country	Name	City	State
Australia	Fremantle Hospital	West Perth
India	Fortis Health Care, Bangalore	Bangalore
India	All India Institute of Medical Sciences	Delhi
India	Sant Parmanand Hospital	Delhi
India	Landmark Hospitals	Hyderabad
India	Deenanath Mangeshkar Hospital	Pune
Japan	Kochi University Hospital	Kochi
Japan	Nihon University Hospital	Tokyo
Korea, Republic of	GangNeung Asan Hospital	Gangneung
Korea, Republic of	Chonnam National University Hwasun Hospital	Hwasun
Korea, Republic of	Chungang University Hospital	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul Asan Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Seoul St. Mary's Hospital	Seoul
Korea, Republic of	Pusan National University Yangsan Hospital	Yangsan
New Zealand	Waikato Hospital	Hamilton	Waikato
Singapore	Singapore General Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Countries where clinical trial is conducted

Australia,  India,  Japan,  Korea, Republic of,  New Zealand,  Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Implant Survivorship	Implant survivorship based on removal of the study device and will be summarized using Kaplan-Meier analysis	Up to 5 years post surgery
Primary	Adverse Events (Safety)	Safety based on incidence and frequency of adverse events	Up to 5 years post surgery
Primary	Clinical Performance	Clinical Performance measured by overall pain and function and qualify of life Measured using EQ5D questionnaire and Knee Society Score	Up to 5 years post surgery
Primary	Clinical Performance	Clinical Performance measured by physician assessment of radiographs form. Data collected include the position and assessment of the radiographs of the operated knee	Up to 5 years post surgery