Mechanical Alignment vs Kalipered Kinematic Alignment Total Knee Arthroplasty
Key facts
- Who runs it
- Northwestern University
- Where
- Chicago, United StatesSee the site
- Trial code
- Status
- Recruiting
- People taking part
- 95 people, planned
- Started
- 1 Aug 2024
- Expected to end
- Dec 2028
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Mechanical Alignment (MA)
- Kinematic Alignment (KA) Interventions:
- Record updated
- 24 March 2026
Who can take part
- Age
- 21 years to 79 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- 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
Who cannot take part
- Revision TKA or other prior knee surgery other than arthroscopy or arthroscopic-assisted ligament reconstruction
- Patients receiving workers' compensation for study condition
- Patients with comorbidities preventing surgery
- 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
- Varus or Valgus malalignment >15 degrees to mechanical axis
- Flexion contracture >15 degrees or flexion <90 degrees
- BMI >40
- Patients who cannot complete questionnaires in English
- Patients who are not able to provide informed consent
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 21 and 79 years old?
Where in United States
- Northwestern MedicineChicago, United StatesContact: Melissa Shauver, MPHTaking people
About the trial
What the trial wants to find out
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.
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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.
The 2 groups in the trial
- Mechanical Alignment (MA)Existing treatment, for comparison
Primary TKA with the Medacta SpheriKA, utilizing either MA methodology.
- Kinematic Alignment (KA)Existing treatment, for comparison
Primary TKA with the Medacta SpheriKA, utilizing either KA methodology.
Treatment: Kinematic Alignment (KA) Interventions:
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Prospective, Randomized, Single-blinded Clinical Trial Comparing Mechanical Alignment vs Kalipered Kinematic Alignment Total Knee Arthroplasty Using Medacta Spherika
- Fit questions
- Built from NCT06617871, who can take part
- Record updated
- 24 March 2026