Mechanical Alignment vs Kalipered Kinematic Alignment Total Knee Arthroplasty

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Northwestern University
Study ID
NCT06617871
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
21 Years - 79 Years
Healthy Volunteers
Not accepted

Interventions

  • Mechanical Alignment (MA) — PROCEDURE
    Primary TKA with the Medacta SpheriKA, utilizing either MA methodology.
  • Kinematic Alignment (KA) Interventions: — PROCEDURE
    Primary TKA with the Medacta SpheriKA, utilizing either KA methodology.

Study Details

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.

Key Dates

Start date
Aug 1, 2024
Status verified
Mar 2026
Primary completion
Jul 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
95 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

6-week Knee Injury and Osteoarthritis - Joint Replacement Score (KOOS-JR) [ Time Frame: 6 weeks postoperative ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Northwestern MedicineChicagoIllinois60611
Melissa Shauver, MPH
[email protected]
312-472-6024
Megan VanDyke, BSN
[email protected]
312-472-3445

Find similar trials in Chicago, IL

By condition
Osteoarthritis (other)
By specialty
OrthopedicsMusculoskeletal disorders
By research site
Northwestern Medicine· Chicago, IL

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