Recruiting

Mechanical Alignment vs. Kalipered Kinematic Alignment

Sponsor:

Northwestern University

Code:

NCT06617871

Conditions

Knee Osteoarthritis

Knee Arthropathy

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

Interventions

Mechanical Alignment (MA)

Kinematic Alignment (KA) Interventions:

Study Details

Brief 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.

Conditions

Knee Osteoarthritis

Knee Arthropathy

Study ID

NCT06617871

Start date

Aug 1, 2024

Status verified date

Mar, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Jul, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

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
  • 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

Study Design

Enrollment

95 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Mechanical Alignment (MA)

Primary TKA with the Medacta SpheriKA, utilizing either MA methodology.

Kinematic Alignment (KA) Interventions:

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 and Locations

Central contacts

Locations

Northwestern Medicine

Recruiting

Chicago, Illinois, United States, 60611

Contacts

More Information

Sponsor

Northwestern University

Last update posted

Mar 24, 2026

Last verified

Mar, 2026

Keywords

  • randomized trial
  • knee arthroplasty

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Northwestern University on 2026-03-24.