Cemented vs Cementless Persona Keel RCT

Study Overview
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Brief Summary
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The main objective of this study is to evaluate the safety, performance, and clinical benefits of the Persona Keel cementless and cemented knee.

Detailed Description
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This is a prospective, multi-center, randomized controlled trial to demonstrate safety, performance, and clinical benefits of the Persona Keel CR Knee System and instrumentation. Participants that meet eligibility criteria and sign an institutional review board (IRB) Informed Consent form will be randomized to receive either the Persona OsseoTi Keel Cementless System or the Persona Keel Cemented System. Participants will be blinded to which arm they have been randomized to until after surgery. All study participants will undergo preoperative clinical evaluations prior to their total knee arthroplasty. Investigators will collect clinical data for up to 5 years; follow-up clinic visits will occur at 3 months, 1 year, 2 years, and 5 years after surgery. A maximum of 10 sites will contribute to this study. There will be a maximum of 300 participants enrolled (150 Cementless, 150 Cemented).

Official Title
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Randomized Controlled Trial to Compare Persona OsseoTi Keel Cementless TKA vs Persona Keel Cemented TKA

Conditions
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Polyarthritis, Knee Pain Chronic, Rheumatoid Arthritis, Osteoarthritis, Traumatic Arthritis, Avascular Necrosis, Varus Deformity, Valgus Deformity, Flexion Deformity of Knee

Intervention / Treatment
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* Device: Cementless Persona Knee System
* Device: Cemented Persona Knee System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is of legal age and skeletally mature Patient is willing and able to provide written Informed Consent by signing and dating the IRB/EC approved Informed Consent document Patient is willing and able to complete scheduled follow-up evaluations as defined in the study protocol Independent of study participation, patient qualifies for either cemented or cementless total knee arthroplasty based upon physical exam and medical history, and meets the approved indications for use of the commercially available Persona Keel Knee System with appropriately matched Zimmer Biomet components implanted in accordance with product labeling. Exclusion Criteria: Patient is unwilling to sign the Informed Consent Patient is currently participating in any other surgical intervention or pain management study Patient is pregnant or considered a member of a protected (vulnerable) population whose inclusion in the study would be inappropriate (e.g., prisoner; pediatric patients) Patient has a mental or neurologic condition who is unwilling or incapable of following postoperative care instructions 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 Patient is institutionalized or is a known drug abuser, a known alcoholic or cannot understand the requirements of study participation Patient is scheduled to undergo simultaneous bilateral total knee arthroplasty Study Device-Specific Exclusion Criteria: Previous history of infection in the affected joint and/or other local/systematic infection that may affect the prosthetic joint Insufficient bone stock on femoral or tibial surfaces. Neuropathic arthropathy Osteoporosis or any loss of musculature or neuromuscular disease that compromises the affected limb A stable, painless arthrodesis in a satisfactory functional position Severe instability secondary to the absence of collateral ligament integrity Rheumatoid arthritis (RA) accompanied by an ulcer of the skin or a history of recurrent breakdown of the skin The kinematic alignment surgical technique is contraindicated for patients with greater than 5° valgus deformity with MCL insufficiency

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cementless Persona Keel Knee System<br>Persona PPS CoCr Cementless Femur and Persona OsseoTi Keel Cementless Tibia | Device: Cementless Persona Knee System<br>* The Persona Keel Knee system is a total knee system used in the replacement of the knee joint.<br>* Other names: Cementless Tibia;|
| Active Comparator: Cemented Persona Keel Knee System<br>Persona Keel Cemented Tibia | Device: Cemented Persona Knee System<br>* The Persona Keel Knee system is a total knee system used in the replacement of the knee joint.<br>* Other names: Keel Tibia;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxford Knee Score (OKS) | 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. The primary endpoint is based on the change in OKS scores from baseline to 2-year postoperative follow-up as well as from baseline to 5-year postoperative follow-up. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival Rate of Implant | 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. | 5 years | 
| Frequency and types of Adverse Events | 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. | 5 years | 
| EuroQol-5 Dimension-5 Level (EQ-5D-5L) Questionnaire | 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 (cemented or cementless). This change will also be compared between the cohorts (delta from baseline to 2 years and baseline to 5 years in the cementless group compared to the same delta in the cemented group). | 5 years | 
| Numeric Rating Scale (Pain) | 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. | 5 years | 
| Patient Expectations Pre- and Post-op | Per the 2011 Knee Society scoring manual: [This] is a three-question fifteen-point scale that is collected pre-operatively and post-operatively. The pre-operative questions reflect the patient's opinion on the extent to which the patient expects that the operation will improve their knee pain, and their ability to perform their activities of daily living and recreational activities. The post-operative questions reflect the extent to which the outcome after the operation has met the patient's pre-operative expectations with respect to pain and function. Higher scores preoperatively indicate more positive expectations of the patient's total knee replacement surgery, and higher scores postoperatively indicate | 5 years | 
| Rate of Radiolucencies | Radiographic parameters to be evaluated include, but are not limited to, radiolucencies, osteolysis, hypertrophy, subsidence, and heterotopic ossification. All radiographic evaluations performed according to the protocol will be reviewed by the investigator at the time of the evaluation for significant radiographic findings. | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Total Knee Replacement, Total Knee Arthroplasty, Osteoarthritis, Rheumatoid Arthritis, Cementless, Cementless Knee