Avascular Necrosis of the Femoral Condyle, Knee Pain Chronic, Moderate Varus, Valgus or Flexion Deformities, Osteoarthritis, Polyarthritis, Rheumatoid Arthritis, Traumatic Arthritis
Conditions
Keywords
Osteoarthritis, Rheumatoid Arthritis, Traumatic Arthritis, Polyarthritis, Total Knee Arthroplasty
Brief 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.
Detailed description
The study design is a prospective, multicenter, study of the commercially available Persona fixed bearing knee implants. The study will require each site to obtain IRB approval prior to study enrollment. All potential study subjects will be required to participate in the Informed Consent Process. All study subjects will undergo preoperative clinical evaluations prior to their total knee arthroplasty. The post-operative clinical and radiographic evaluations will be conducted at 6 weeks, 6 months, 1 year, 2, 3, 5, 7, and 10 years. 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. The assessments will include: implant survivorship based on removal of a study device; safety based on incidence and frequency of adverse events; and clinical performance measured by overall pain and function, quality of life data, radiographic parameters and survivorship.
Interventions
Primary Total Knee Arthroplasty
Sponsors
Zimmer Biomet
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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: 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; or e) 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 provide written Informed Consent by signing and dating the IRB or EC approved Informed Consent Form * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Knee Society Score | 10 years | Knee Society Score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| EQ-5D | 10 years | EQ-5D |
Countries
United States
Outcome results
None listed