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Kinematic Alignment vs Mechanical Alignment for Total Knee Arthroplasty

NCT05461638 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2022-07-18

No results posted yet for this study

Summary

This is a prospective, randomized, single-blinded, multi-center trial comparing Kinematic Alignment vs Mechanical Alignment in TKA patients using patient reported outcomes, clinical and functional performance tests and radiographic analyses.

Conditions

Interventions

PROCEDURE

Mechanical Alignment and Unrestricted Kinematic Alignment using Medacta GMK Sphere with MyKnee Custom guides

MA places the implant in an average position for all patients based on pre-determined definition of acceptable knee alignment and has become the most common surgical approach for TKA and Unrestricted KA places the implant in a custom position for each patient, completely matching individual anatomy and restoring natural alignment to that of the prearthritic knee.

PROCEDURE

Mechanical Alignment and Restricted Kinematic Alignment using Medacta GMK Sphere with custom cutting guides

MA places the implant in an average position for all patients based on pre-determined definition of acceptable knee alignment and has become the most common surgical approach for TKA and Restricted KA places the implant in a custom position for each patient, closely matching with anatomy and natural alignment of the individual's knee.

Sponsors & Collaborators

  • Medacta USA

    lead INDUSTRY

Principal Investigators

  • Rena Mandino · Associate Director, Clinical Research Medacta USA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-01-05
Primary Completion
2022-04-05
Completion
2022-04-05

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Entities

Diseases

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 NCT05461638 on ClinicalTrials.gov