About this trial
Knee replacement surgery can be performed in one of two ways. Traditionally the goal was for the new joint to be in a neutral position with respect to the femur (thigh bone). This is called Mechanical Alignment (MA). The neutral position is different than the human knee's natural position, so MA often requires the surgeon to make additional cuts to the ligaments and other soft tissue around the knee. More recently surgeons have started to place the new joint in a position that more closely replicates the natural alignment of the human knee. This is called Kinemetic Alignment (KA). KA can be done without additional soft tissue dissection but the procedure requires a higher level of precision that can be difficult to achieve in every case.
Some studies have found no difference in outcomes between MA and KA, whereas others have found KA to be superior. But these were small studies or studies that did not consider patient-rated outcomes.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient undergoing primary TKA with a medially-stabilized SpheriKA knee system
Able to read and understand consent form and PRO instruments and willing to return for follow up visits
Disqualifiers
Varus or Valgus malalignment >15 degrees to mechanical axis
Flexion contracture >15 degrees or flexion <90 degrees
BMI >40
Revision TKA or other prior knee surgery other than arthroscopy or arthroscopic-assisted ligament reconstruction
Trial design
Parallel
Treatments tested in this trial
Mechanical Alignment (MA)
Procedure/SurgeryPrimary TKA with the Medacta SpheriKA, utilizing either MA methodology.
Kinematic Alignment (KA) Interventions:
Procedure/SurgeryPrimary TKA with the Medacta SpheriKA, utilizing either KA methodology.
Treatment groups
Trial outcomes
Primary outcomes
6-week Knee Injury and Osteoarthritis - Joint Replacement Score (KOOS-JR)
The Knee Injury and Osteoarthritis Score - Joint Replacement (KOOS-JR) score; range: 0 (worst knee health) - 100 (perfect knee health)
Secondary outcomes
Forgotten Joint Score (FJS)
Forgotten Joint Score (FJS) questionnaire score; range: 0 (worst outcome) - 100 (best outcome)
Sponsors and contacts
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Northwestern University
Lead sponsor
Medacta International SA
Collaborator