Prophecy Guide Outcomes in Total Knee Replacement Surgery

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial Description

Knee joint pain is often the cause of reduced joint and limb function. Total knee joint replacement is a procedure which aims to relieve pain and help to improve mobility. There has been continued development and improvement in knee implant design and the instruments required during surgery to assist with the accurate placement of the implant. These developments have reduced surgery time and assisted in the accurate positioning of the knee implant, which leads to better long term outcomes.

Navigation system is a computerised system currently used intraoperatively to position the Advance knee implant. The Prophecy technique is a pre-operative alignment technique. Patient undergo a MRI or CT scan which is used to manufacture personalised cutting blocks which are then used intraoperatively to position the knee implant. ;

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01163708
Study type	Interventional
Source	Global Orthopaedic Technology
Contact	Hugh English
Phone	+61 1300 436 454
Email	hugh@boss.net.au
Status	Not yet recruiting
Phase	Phase 4
Start date	August 2010
Completion date	December 2017

View Details

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