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NCT Number: NCT06617871

Mechanical Alignment vs Kalipered Kinematic Alignment Total Knee Arthroplasty

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.

Recruiting

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Key information

Age range

21 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

Up to 20% of patients that report dissatisfaction and chronic pain following Total knee arthroplasty (TKA). Prior research has identified patient demographic, comorbidity, and expectations as factors that are associated with dissatisfaction. Emerging literature has also suggested that surgical factors including component alignment, soft tissue balance, and kinematics may play a role in patient satisfaction, and that modifications to alignment may result in better function than performing soft tissue releases. Personalized alignment strategies have been proposed that aim to more closely recreate native knee morphology and kinematics. Kinematic alignment (KA) describes a technique that aims to restore the pre-arthritic joint surfaces and alignment of the femur and tibia by removing the bone and cartilage thickness that will be replaced by the implant, taking into account cartilage wear. KA can therefore be conceptualized as a resurfacing procedure, wherein native joint surfaces are replaced by prosthetic surfaces but the position and alignment of the joint surfaces are not changed. This contrasts with mechanical alignment (MA), in which implants are positioned perpendicular to the mechanical axes of the femur and tibia in a manner independent of the pre-arthritic joint surfaces, and soft tissue releases are performed to bring limb alignment into mechanical neutral.

There have been prior randomized trials comparing kinematic and mechanical alignment, and these have had mixed results regarding the superiority of one approach over the other. The majority of these trials did not use the same operative modality for both groups (manual vs computer-assisted techniques) or did not include relevant patient reported outcomes (PROs). There is a need for a prospective, randomized trial comparing outcomes following kinematic vs mechanical alignment TKA, with the same operative modality used in both groups with inclusion of relevant PROs.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 6-week Knee Injury and Osteoarthritis - Joint Replacement Score (KOOS-JR)

    Time frame: 6 weeks postoperative

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

Secondary outcomes

  1. Forgotten Joint Score (FJS)

    Time frame: 1 year postoperative

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

Study contacts

Contact information is provided by the study sponsor or research team.

Megan VanDyke, BSN

CONTACT

[email protected]

312-472-3445

Melissa Shauver, MPH

CONTACT

[email protected]

312-472-6024

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • Medacta International SA

Registry information

Official study title

A Prospective, Randomized, Single-blinded Clinical Trial Comparing Mechanical Alignment vs Kalipered Kinematic Alignment Total Knee Arthroplasty Using Medacta Spherika

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Oct 1, 2024
Registry last updated
Mar 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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