Cemented vs Cementless Persona Keel RCT

Korábbi kezelés

• Patient is currently participating in any other surgical intervention or pain management study
• Patient is institutionalized or is a known drug abuser, a known alcoholic or cannot understand the requirements of study participation
• Previous history of infection in the affected joint and/or other local/systematic infection that may affect the prosthetic joint

Más betegség

• 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
• Osteoporosis or any loss of musculature or neuromuscular disease that compromises the affected limb
• 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

Egyéb

• Patient is unwilling to sign the Informed Consent
• 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 is scheduled to undergo simultaneous bilateral total knee arthroplasty
  • Study Device-Specific Exclusion Criteria:
• Insufficient bone stock on femoral or tibial surfaces.
• Neuropathic arthropathy
• A stable, painless arthrodesis in a satisfactory functional position
• Severe instability secondary to the absence of collateral ligament integrity

• 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.