Prospective, Multi-centre Outcomes Study of Persona® Knee System in Total Knee Arthroplasty
- Conditions
- Health Condition 1: M170- Bilateral primary osteoarthritis of kneeHealth Condition 2: null- Patients who require primary Total Knee Arthroplasty using the Persona fixed bearing knee system.Health Condition 3: M171- Unilateral primary osteoarthritisof knee
- Registration Number
- CTRI/2014/09/005055
- Lead Sponsor
- Zimmer India Private Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 344
A patient must meet the following criteria to be eligible for participation:
1. Age 18 to 80 years old, inclusive.
2. 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:
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.
e) The salvage of previously failed surgical attempts that did not include partial or total knee arthroplasty of the ipsilateral knee.
3. Participated in a study-related informed consent process.
4. Willing and able to provide written informed consent by signing and dating the IRB/EC approved informed consent form.
5. Willing and able to complete scheduled study procedures and follow-up
evaluations.
6. Independent of study participation, patient is a candidate for commercially available Persona fixed bearing knee system implanted in accordance with product labelling.
A patient must not meet the following criteria to be eligible for participation:
1. Currently participating in any other surgical intervention studies or pain management studies
2. Previous history of infection in the affected joint and/or other local/systemic infection that may affect the prosthetic joint.
3. Insufficient bone stock on femoral or tibial surfaces.
4. Skeletal immaturity.
5. Neuropathic arthropathy.
6. Any loss of musculature or neuromuscular disease that compromises the affected limb.
7. Stable, painless arthrodesis in a satisfactory functional position.
8. Severe instability secondary to the absence of collateral ligament integrity.
9. Rheumatoid arthritis accompanied by an ulcer of the skin or a history of recurrent breakdown of the skin.
10. Known or suspected sensitivity or allergy to one or more of the implant materials.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 (TKA).Timepoint: Each patient will return to the clinic for follow-ups ats <br/ ><br>at 6 weeks, 6 months, 1 year, 2 years, 3 years and 5 years postoperatively
- Secondary Outcome Measures
Name Time Method The assessments will include: <br/ ><br>- Implant survivorship based on removal of the study device <br/ ><br>- Safety based on incidence and frequency of adverse events <br/ ><br>- Clinical performance measured by overall pain and function, quality of life data, radiographic parameters and implant survivorshipTimepoint: Each patient will return to the clinic for follow-ups ats <br/ ><br>at 6 weeks, 6 months, 1 year, 2 years, 3 years and 5 years postoperatively