Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
300 participants
INTERVENTIONAL
2023-07-25
2032-12-31
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Cementless Persona Keel Knee System
Persona PPS CoCr Cementless Femur and Persona OsseoTi Keel Cementless Tibia
Cementless Persona Knee System
The Persona Keel Knee system is a total knee system used in the replacement of the knee joint.
Cemented Persona Keel Knee System
Persona Keel Cemented Tibia
Cemented Persona Knee System
The Persona Keel Knee system is a total knee system used in the replacement of the knee joint.
Interventions
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Cementless Persona Knee System
The Persona Keel Knee system is a total knee system used in the replacement of the knee joint.
Cemented Persona Knee System
The Persona Keel Knee system is a total knee system used in the replacement of the knee joint.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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. 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
2. Patient is currently participating in any other surgical intervention or pain management study
3. 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)
4. Patient has a mental or neurologic condition who is unwilling or incapable of following postoperative care instructions
5. 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
6. Patient is institutionalized or is a known drug abuser, a known alcoholic or cannot understand the requirements of study participation
7. Patient is scheduled to undergo simultaneous bilateral total knee arthroplasty
8. Previous history of infection in the affected joint and/or other local/systematic infection that may affect the prosthetic joint
9. Insufficient bone stock on femoral or tibial surfaces.
10. Neuropathic arthropathy
11. Osteoporosis or any loss of musculature or neuromuscular disease that compromises the affected limb
12. A stable, painless arthrodesis in a satisfactory functional position
13. Severe instability secondary to the absence of collateral ligament integrity
14. Rheumatoid arthritis (RA) accompanied by an ulcer of the skin or a history of recurrent breakdown of the skin
15. The kinematic alignment surgical technique is contraindicated for patients with greater than 5° valgus deformity with MCL insufficiency
18 Years
ALL
No
Sponsors
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Zimmer Biomet
INDUSTRY
Responsible Party
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Locations
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Centura Health
Westminster, Colorado, United States
Northwestern University
Chicago, Illinois, United States
Johns Hopkins University
Baltimore, Maryland, United States
Oregon Health & Science University
Portland, Oregon, United States
Rothman Institute
Bryn Mawr, Pennsylvania, United States
Lehigh Valley Hospital - Dickson City
Dickson City, Pennsylvania, United States
Houston Methodist Hospital
Houston, Texas, United States
Anderson Orthopaedic Research Institute
Alexandria, Virginia, United States
Countries
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Other Identifiers
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CMG2022-08K
Identifier Type: -
Identifier Source: org_study_id
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