Mechanical Alignment vs Kalipered Kinematic Alignment Total Knee Arthroplasty

NCT06617871 | Recruiting

• 1 other identifier: STU00219231
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

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

Keywords

randomized trial; knee arthroplasty

Outcome Measures

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)

  6 weeks postoperative

Secondary Outcomes (1)

• Forgotten Joint Score (FJS)

  1 year postoperative

Study Arms (2)

Mechanical Alignment (MA)

ACTIVE COMPARATOR

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

Procedure: Mechanical Alignment (MA)

Kinematic Alignment (KA)

ACTIVE COMPARATOR

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

Procedure: Kinematic Alignment (KA) Interventions:

Interventions

Kinematic Alignment (KA) Interventions: PROCEDURE

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

Kinematic Alignment (KA)

Mechanical Alignment (MA) PROCEDURE

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

Mechanical Alignment (MA)

Eligibility Criteria

• Age: 21 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Northwestern University: lead
• Medacta International SA: collaborator

Study Sites (1)

Northwestern Medicine

Chicago, Illinois, 60611, United States

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Methods

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Adam Edelstein, MD

  Assistant Professor of Orthopaedic Surgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Melissa Shauver, MPH

CONTACT

312-472-6024; melissa.shauver@northwestern.edu

Megan VanDyke, BSN

CONTACT

312-472-3445; megan.vandyke@nm.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Orthopaedic Surgery

Model Details: 1:1

Study Record Dates

• First Submitted: September 25, 2024
• First Posted: October 1, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Supporting information will be available after all manuscripts have been published.
• Access Criteria: Contact study PI

Locations

US (1)