Avascular Necrosis of Femoral Condyle, Collagen Disorders, Flexion Deformity of Knee, Osteo Arthritis of the Knee, Polyarthritis, Rhematoid Arthritis, Traumatic Arthritis of Knee (Diagnosis), Valgus Deformity, Varus Deformity
Conditions
Keywords
Total Knee, Total knee arthroplasty, Knee replacement
Brief summary
The goal of this study is to generate clinical evidence and evaluate the safety and performance of the Persona® SoluTion® PPS Femurs in the US market, with data supporting global regulatory submissions, including CE marking under EU MDR. The target population consists of adults undergoing knee arthroplasty with the Persona SoluTion femoral component paired with a Medial Congruent (MC) or Posterior Stabilized (PS) articulating surface in line with its current cleared Instructions for Use (IFU). The primary endpoint is the assessment of clinical performance and benefits by evaluating the average change in the KOOS JR score between pre-operative and 2-year post-operative follow-up.
Interventions
DEVICETotal knee arthroplasty
The screening population will consist of patients for whom clinical decision has been made to use the Persona® SoluTion® PPS femoral implant in total knee arthroplasty prior to enrollment in the research.
Sponsors
Zimmer Biomet
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient is of legal age of consent and skeletally mature 2. Patient is willing and able to provide written Informed Consent by signing and dating the IRB/EC approved Informed Consent document 3. Patient is willing and able to complete scheduled follow-up evaluations as defined in the study protocol 4. Patient qualifies for total knee arthroplasty based upon physical exam and medical history and meets the approved indications for use of the Persona® SoluTion® PPS femoral implant and appropriate compatible components, within a pre-specified variant configuration (cohort). 5. A clinical decision has been made to use the Persona® SoluTion® PPS femoral implant prior to enrollment in the research
Exclusion criteria
1. Patient is currently participating in any other surgical intervention or pain management study 2. Patient is pregnant or considered a member of a protected (vulnerable) population whose inclusion in the study is inappropriate (e.g. prisoner, mentally incompetent) 3. Patient has a mental or neurologic condition who is unwilling or incapable of following postoperative care instructions 4. Patient has a condition which would, in the judgement of the Investigator, place the patient at undue risk or interfere with the conduct of the study 5. Patient is institutionalized or is a known drug abuser, a known alcoholic or cannot understand the requirements of study participation 6. Previous history of infection in the affected joint and/or other local/systematic infection that may affect the prosthetic joint 7. Insufficient bone stock on femoral or tibial surfaces 8. Skeletal immaturity 9. Neuropathic arthropathy 10. Osteoporosis or any loss of musculature or neuromuscular disease that compromises the affected limb 11. A stable, painless arthrodesis in a satisfactory functional position 12. Severe instability secondary to the absence of collateral ligament integrity 13. Rheumatoid arthritis (RA) accompanied by an ulcer of the skin or a history of recurrent breakdown of the skin 14. Study device not implanted during surgery, or surgery did not occur 15. KOOS JR score not collected pre-operatively 16. Patient requires simultaneous bilateral knee surgery for treatment of the diagnosed condition
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in KOOS JR Score between pre-op and 2 years post-op | 2 years | A 7-item shortened version of the Knee injury and Osteoarthritis Outcome Score (KOOS), specifically designed to assess knee health in patients undergoing total knee arthroplasty (TKA). Raw scores are converted to an interval score ranging from 0 to 100, where 0 represents complete knee disability and 100 represents perfect knee health (higher scores indicate less pain and better function). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| KOOS JR Score | 5 years | A 7-item shortened version of the Knee injury and Osteoarthritis Outcome Score (KOOS), specifically designed to assess knee health in patients undergoing total knee arthroplasty (TKA). Raw scores are converted to an interval score ranging from 0 to 100, where 0 represents complete knee disability and 100 represents perfect knee health (higher scores indicate less pain and better function). |
| Oxford Knee Score (OKS) | 5 years | A 12-item PROM was specifically designed and developed to assess function and pain after TKA. This tool is short, reproducible, valid, and sensitive to clinically important changes. Possible scores range from a minimum 0 to maximum 48 points, with higher scores indicating less pain and fewer functional limitations. |
| EuroQol-5 Dimension-5 Level (EQ-5D-5L) Questionnaire | 5 years | The EQ-5D-5L instrument comprises a short descriptive system questionnaire and a visual analogue scale (EQ VAS). The questionnaire produces an "index" score that ranges from 0 to 1, where 0 is the value of a health state equivalent to dead; and 1 is the value of full health, with higher scores indicating higher health utility. The EQ VAS is a 0 -100 scale where patients are asked to indicate their overall health on the day of questionnaire completion. 100 indicates the best health imaginable and 0 indicates the worst health imaginable. Change in Index and EQ VAS scores will be compared from baseline to 2-year follow-up as well as from baseline to 5-year postoperative follow-up for each cohort. This change will also be compared between the cohorts. |
| Numeric Rating Scale (Pain) | 5 years | The 11-item pain NRS asks patients to rate their current pain intensity from 0 ("no pain") to 10 ("worst possible pain"). It is the most widely used instrument for pain screening with higher scores indicating greater pain intensity. |
| Survival Rate of Implant | 10 years | Survival Rate (Survivorship) will be both assessed by revision/additional surgeries to the affected joint due to aseptic loosening only or by revision, removal, exchange of the implanted device due to any reason. Aseptic loosening and other reasons for additional surgeries may be identified by radiographic imaging. |
| Frequency and types of Adverse Events | 10 years | The safety of the system will be assessed by monitoring the frequency and incidence of adverse events. Relation of the events to implant, instrumentation and/or procedure should be specified. |
| Assessment of the prevalence of metal hypersensitivities using a metal Lymphocyte Transformation Test (LTT) | 10 years | The Orthopedic Panel 2 tests for hypersensitivity to aluminum, cobalt, chromium, iron, molybdenum, nickel, vanadium, zirconium, titanium alloy particles, cobalt alloy particles, bone cement particles, and bone cement liquid. |
Countries
United States
Outcome results
None listed