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A Prospective, Randomized, Single-blinded Clinical Trial Comparing Mechanical Alignment vs Kalipered Kinematic Alignment Total Knee Arthroplasty Using Medacta Spherika

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 21
Maximum Age: 79
Healthy Volunteers: f
View:

• 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

Locations
United States
Illinois
Northwestern Medicine
RECRUITING
Chicago
Contact Information
Primary
Melissa Shauver, MPH
melissa.shauver@northwestern.edu
312-472-6024
Backup
Megan VanDyke, BSN
megan.vandyke@nm.org
312-472-3445
Time Frame
Start Date: 2024-08-01
Estimated Completion Date: 2028-12
Participants
Target number of participants: 95
Treatments
Active_comparator: Mechanical Alignment (MA)
Primary TKA with the Medacta SpheriKA, utilizing either MA methodology.
Active_comparator: Kinematic Alignment (KA)
Primary TKA with the Medacta SpheriKA, utilizing either KA methodology.
Sponsors
Collaborators: Medacta International SA
Leads: Northwestern University

This content was sourced from clinicaltrials.gov