Cemented Vs Cementless Persona Keel RCT
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Details and patient eligibility
About
The main objective of this study is to evaluate the safety, performance, and clinical benefits of the Persona Keel cementless and cemented knee.
Full description
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).
Enrollment
Sex
Ages
Volunteers
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
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Patient is unwilling to sign the Informed Consent
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Patient is currently participating in any other surgical intervention or pain management study
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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)
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Patient has a mental or neurologic condition who is unwilling or incapable of following postoperative care instructions
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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
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Patient is institutionalized or is a known drug abuser, a known alcoholic or cannot understand the requirements of study participation
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Patient is scheduled to undergo simultaneous bilateral total knee arthroplasty
Study Device-Specific Exclusion Criteria:
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Previous history of infection in the affected joint and/or other local/systematic infection that may affect the prosthetic joint
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Insufficient bone stock on femoral or tibial surfaces.
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Neuropathic arthropathy
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Osteoporosis or any loss of musculature or neuromuscular disease that compromises the affected limb
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A stable, painless arthrodesis in a satisfactory functional position
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Severe instability secondary to the absence of collateral ligament integrity
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Rheumatoid arthritis (RA) accompanied by an ulcer of the skin or a history of recurrent breakdown of the skin
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The kinematic alignment surgical technique is contraindicated for patients with greater than 5° valgus deformity with MCL insufficiency
Trial design
Primary purpose
Allocation
Interventional model
Masking
300 participants in 2 patient groups
Trial contacts and locations
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Central trial contact
Darin Fawley
Data sourced from clinicaltrials.gov
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