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Prophecy Guide Outcomes in Total Knee Replacement Surgery

NCT01163708 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 188

Last updated 2010-07-29

No results posted yet for this study

Summary

This project aims to assess two different techniques used to position the knee replacement implant during surgery. The patients will be randomised to receive either the following:

1. The established Navigation System (gold standard)
2. The new Prophecy Technique (validated by the Navigation System)

The study hypothesis is there will be no difference between the gold standard Navigation system and the Prophecy technique in relation to the placement of the knee implant.

Conditions

  • Osteoarthritis of the Knee
  • Total Knee Replacement

Interventions

DEVICE

Prophecy Technique

Navigation computerised system is used intraoperatively to correct implant the Advance knee implant. Prophecy is a pre-alignment technique where a pre-op MRI or CT scan is used to manufacture personalised cutting blocks to assist the surgeon in correct implanting the Advance knee implant intraoperatively

DEVICE

Navigation System

Sponsors & Collaborators

  • LSS Surgical Pty Ltd

    collaborator UNKNOWN

  • Global Orthopaedic Technology

    lead INDUSTRY

Principal Investigators

  • Hugh English · Brisbane Orthopaedic Specialist Services

Study Design

Allocation
RANDOMIZED
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2017-08-31
Completion
2017-12-31

Countries

  • Australia

Study Locations

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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 NCT01163708 on ClinicalTrials.gov