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Mechanical Alignment vs Kalipered Kinematic Alignment Total Knee Arthroplasty

NCT06617871 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 95

Last updated 2026-03-24

No results posted yet for this study

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

Interventions

PROCEDURE

Mechanical Alignment (MA)

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

PROCEDURE

Kinematic Alignment (KA) Interventions:

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

Sponsors & Collaborators

Principal Investigators

  • Adam Edelstein, MD · Assistant Professor of Orthopaedic Surgery

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-01
Primary Completion
2028-07-31
Completion
2028-12-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06617871 on ClinicalTrials.gov