A Comparative Study of Knee Systems

A Comparative Study of Knee Systems Employing Personalized Computer Generated Cutting Guides for Total Knee Arthroplasty

The custom cutting guides personalized for each patient via pre-operative MRI will result in significantly faster intraoperative time with comparable knee alignment accuracy, cost, knee function, and patient satisfaction.

Inclusion Criteria:

• must be scheduled to undergo TKA with no bilateral TKA planned within 6 weeks of the initial surgery date
• must be 18 years of age or older
• must be capable and willing to provide informed consent
• must have flexion contracture less than 15 degrees.
• must have ligament stability no more than 2 degrees instability in varus/valgus extension stress

Exclusion Criteria:

• medical condition or personal circumstances that will prevent participation and completion of the follow-up visits at 3 weeks, 6 weeks and 3 months post-op
• currently participating in or has participated in (within 30 days prior to inclusion in this study) another clinical trial of an investigational drug, biologic, device, or procedure
• known pre-operative systemic infections, uncontrolled diabetes, or diseases or conditions that are known to interfere with the wound healing process
• Knee alignment deformities greater than 7 degrees varus or valgus
• known prior knee revisions or previous surgeries deemed to compromise the TKA incision exposure
• known medical conditions prohibiting the use of MRI or nickel allergy, sensitivity, or hardware in the region of the knee