Mechanical Alignment vs Kalipered Kinematic Alignment Total Knee Arthroplasty

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-79
SponsorNorthwestern University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Mechanical Alignment (MA)

    Procedure/Surgery

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

  • Kinematic Alignment (KA) Interventions:

    Procedure/Surgery

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

Treatment groups

95 Participants
are divided into 2 treatment groups
Group A: Mechanical Alignment (MA)Active comparator 1 intervention
Group B: Kinematic Alignment (KA)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

6-week Knee Injury and Osteoarthritis - Joint Replacement Score (KOOS-JR)

The Knee Injury and Osteoarthritis Score - Joint Replacement (KOOS-JR) score; range: 0 (worst knee health) - 100 (perfect knee health)

Time frame
6 weeks postoperative

Secondary outcomes

1

Forgotten Joint Score (FJS)

Forgotten Joint Score (FJS) questionnaire score; range: 0 (worst outcome) - 100 (best outcome)

Time frame
1 year postoperative

Other outcomes

Sponsors and contacts

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Northwestern University

Lead sponsor

Medacta International SA

Collaborator