Persona 0° Keel Randomized Controlled Trial
Study Details
Study Description
Brief Summary
The main objective of this study is to evaluate the safety, performance, and clinical benefits of the Persona 0° Keel cementless and cemented knee.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
This is a prospective, multi-center, randomized controlled trial to demonstrate safety, performance, and clinical benefits of the Persona 0° 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 0° Spiked Keel Cementless System or the Persona 0° 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 224 participants enrolled (112 Cementless, 112 Cemented).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Cementless Persona 0-° Keel Knee System Persona PPS CoCr Cementless Femur and Persona OsseoTi 0° Spiked Keel Cementless Tibia |
Device: Cementless Persona 0° Knee System
The Persona 0° Keel Knee system is a total knee system used in the replacement of the knee joint.
Other Names:
|
| Active Comparator: Cemented Persona 0-° Keel Knee System Persona 0° Keel Cemented Tibia |
Device: Cemented Persona 0° Knee System
The Persona 0° Keel Knee system is a total knee system used in the replacement of the knee joint.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Oxford Knee Score [5 years]
A 12-item PROM specifically designed and developed to assess function and pain after TKA. This tool is short, reproducible, valid, and sensitive to clinically important changes.
Secondary Outcome Measures
- Survivorship of Implant [5 years]
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. Asceptic loosening and other reasons for additional surgeries may be identified by radiographic imaging.
- Frequency and types of Adverse Events [5 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.
- EQ-5D-5L [5 years]
Each EQ-5D instrument comprises a short descriptive system questionnaire and a visual analogue scale (EQ VAS). The questionnaire provides a simple descriptive profile of a respondent's health state. The EQ VAS provides an alternative way to elicit an individual's rating of the individual's own overall current health.
- 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.
- Patient Expectations Pre- and post-op (KSS) [5 years]
This is a short self-report questionnaire to reflect the patient's opinion on the extent to which they expect the operation will improve their knee pain pre-operatively; then for evaluating patient satisfaction with the outcome of hip and knee replacement surgery.
- Rate of Radiolucencies [5 years]
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.
Other Outcome Measures
- Operative Room Time [1 Day of Surgery]
Evaluation of differences in operative times between implantation of cemented and cementless systems.
Eligibility Criteria
Criteria
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 0°ׄ 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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Zimmer Biomet
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CMG2022-08K