N/A
N=299
Zimmer POLAR - Total Knee Arthroplasty (TKA)
Osteoarthritis · RheumatoId Arthritis · Traumatic Arthritis · Polyarthritis
Bottom Line
View on ClinicalTrials.gov: NCT01859130 ↗Enrolled (actual)
299
Serious AEs
24.1%
Results posted
Oct 2023
Primary outcome: Primary: Knee Society Scores — 92.9 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Zimmer Persona Total Knee System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Zimmer Biomet
- Primary completion
- Dec 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Knee Society Scores |
92.9 | — |
| SECONDARY EQ-5D |
0.9 | — |
| SECONDARY Forgotten Joint Score (FJS) |
74.9 | — |
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 measured by 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:
- rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis;
- collagen disorders and/or avascular necrosis of the 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;
- Patient has participated in a study-related Informed Consent process;
- 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.
Data sourced from ClinicalTrials.gov (NCT01859130). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.