MedTrace Logo

Navigated Versus Convention Total Knee Arthroplasty

NCT05325060 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2022-04-20

No results posted yet for this study

Summary

The aim of this single blinded randomised control trial study was to assess the accuracy of implantation of components and the clinical outcome and complications with the iNAV electromagnetic navigation system compared with conventional techniques. Secondary outcome measures include Patient reported outcome measures (PROMS) and rates of revision surgery up to 10 years post operatively.

Conditions

  • Arthroplasty, Replacement, Knee
  • Surgery, Computer-Assisted

Interventions

DEVICE

Electromagnetically navigated total knee arthroplasty

The navigated group had surgery using the iNav portable EM navigation system (Zimmer GmbH, Winterthur, Switzerland and Medtronic, Minneapolis, MN, USA) and the definitive implant used was NexGen LPS implant (Zimmer Inc, Warsaw, IN, USA), a fixed-bearing bicruciate-sacrificing total condylar implant using traditional instrumentation with no patellar resurfacing

DEVICE

Conventional total knee arthroplasty

The conventional group received surgery using conventional instrumentation and jigs from the implant manufacturer (Zimmer Inc, Warsaw, IN, USA) and the definitive implant used was NexGen LPS implant (Zimmer Inc, Warsaw, IN, USA), a fixed-bearing bicruciate-sacrificing total condylar implant using traditional instrumentation with no patellar resurfacing

Sponsors & Collaborators

  • NHS Greater Glasgow and Clyde

    lead OTHER

Principal Investigators

  • Mark JG Blyth, Mr · NHS Greater Glasgow and Clyde

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-06-25
Primary Completion
2010-12-07
Completion
2021-07-02
FDA Device
Yes

More Related Trials

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 NCT05325060 on ClinicalTrials.gov