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Effectiveness of Inertial Sensors vs the Conventional Technique for the Execution of the Bone Resections in Primary TKA

NCT04242303 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2023-05-31

No results posted yet for this study

Summary

Comparison of surgical technique for the execution of bone resections in total knee arthroplasty.

Used technique are: a non-invasive extramedullary technique (EM technique) based on the use of inertial sensors for cutting guides positioning and conventional technique (IM technique), based on the use on intramedullary stem.

Our hypothesis is that the EM technique based on the use of inertial sensors leads to a reduction in the number of outliers equal to or greater than 20% compared to the outliers obtained with the conventional technique.

Conditions

Interventions

PROCEDURE

Total knee replacement

Total knee arthroplasty using standard anterior approach. In the EM group, inertial sensor will be used to perform femoral bone cuts. In the IM group, conventional intramedullary nail will be used as reference to perform femoral bone cuts.

Sponsors & Collaborators

  • Istituto Ortopedico Rizzoli

    lead OTHER

Principal Investigators

  • Giulio Maria Marcheggiani Muccioli, MD, PhD · IRCCS Rizzoli Orthopedic Institute

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-18
Primary Completion
2023-05-26
Completion
2023-05-26

Countries

  • Italy

Study Locations

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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 NCT04242303 on ClinicalTrials.gov