Mechanical Alignment vs Kalipered Kinematic Alignment Total Knee Arthroplasty
Recruiting now · Not applicable
Conditions studied: Knee Osteoarthritis, Knee Arthropathy
In brief
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 facts
- Study ID
- NCT06617871
- Run by
- Northwestern University
- People needed
- 95
- Starts
- 2024-08-01
- Expected to finish
- 2028-12-01
- Last updated by the study team
- 2026-03-24
Who can join
Age: 21 and older, up to 79. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
- chronic opioid use
- metabolic musculoskeletal disorder other than osteopenia/osteoporosis
- Patients receiving workers' compensation for study condition
- Patients who cannot complete questionnaires in English
- Patients with comorbidities preventing surgery
- Patients who are not able to provide informed consent
Where it is running
- Northwestern Medicine — Chicago, Illinois, United States (enrolling)
Full record on ClinicalTrials.gov
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