A Prospective, Randomized, Single-blinded Clinical Trial Comparing Mechanical Alignment vs Kalipered Kinematic Alignment Total Knee Arthroplasty Using Medacta Spherika
Northwestern University
Summary
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.
Description
Up to 20% of patients that report dissatisfaction and chronic pain following Total knee arthroplasty (TKA). Prior research has identified patient demographic, comorbidity, and expectations as factors that are associated with dissatisfaction. Emerging literature has also suggested that surgical factors including component alignment, soft tissue balance, and kinematics may play a role in patient satisfaction, and that modifications to alignment may result in better function than performing soft tissue releases. Personalized alignment strategies have been proposed that aim to more closely recreat…
Eligibility
- Age range
- 21–79 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * Diagnosis or history of any of the following * inflammatory arthritis * infection in study knee * chronic pain…
Interventions
- ProcedureMechanical Alignment (MA)
Primary TKA with the Medacta SpheriKA, utilizing either MA methodology.
- ProcedureKinematic Alignment (KA) Interventions:
Primary TKA with the Medacta SpheriKA, utilizing either KA methodology.
Location
- Northwestern MedicineChicago, Illinois