Status:
COMPLETED
Prospective Multi-centre Outcomes Study of Persona Knee System in Total Knee Arthroplasty
Lead Sponsor:
Zimmer Biomet
Conditions:
Knee Osteoarthritis
Eligibility:
All Genders
18-80 years
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 inc...
Eligibility Criteria
Inclusion
- 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:
- Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
- Collagen disorders and/ or avascular necrosis of femoral condyle.
- Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.
- Moderate valgus, varus or flexion deformities.
- 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
- 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.
Key Trial Info
Start Date :
November 19 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 21 2024
Estimated Enrollment :
1017 Patients enrolled
Trial Details
Trial ID
NCT04461626
Start Date
November 19 2014
End Date
August 21 2024
Last Update
August 22 2024
Active Locations (18)
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1
Fremantle Hospital
West Perth, Australia, 6160
2
Fortis Health Care, Bangalore
Bangalore, India, 560076,
3
Sant Parmanand Hospital
Delhi, India, 110 054
4
All India Institute of Medical Sciences
Delhi, India, 110029