Signature Personalised Patient Care System With the Vanguard Knee System Study

NCT ID: NCT01092312

Last Updated: 2017-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

325 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2016-09-30

Brief Summary

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The purpose of this study is to determine whether the percentage cases which have ideal mechanical axial alignment using the Vanguard total Knee implant with the Signature cutting blocks is higher than those without the use of Signature when measured immediately post-operatively.

Detailed Description

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The purpose of this study is to determine whether the percentage cases which have ideal mechanical axial alignment using the Vanguard total Knee implant with the Signature cutting blocks is higher than those without the use of Signature when measured immediately post-operatively. Other outcomes will include knee assessments and patient questionnaires.

Conditions

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Arthroplasty, Replacement, Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Signature Knee Guide

Vanguard Knee System with Signature Knee Guide

Group Type EXPERIMENTAL

Vanguard Knee System with Signature Knee Guide

Intervention Type PROCEDURE

Use of Signature Knee Guide

Conventional Approach

Vanguard Complete Knee System with Conventional Approach

Group Type ACTIVE_COMPARATOR

Vanguard Knee System with conventional Instruments

Intervention Type PROCEDURE

Vanguard Knee System with conventional Instruments

Interventions

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Vanguard Knee System with Signature Knee Guide

Use of Signature Knee Guide

Intervention Type PROCEDURE

Vanguard Knee System with conventional Instruments

Vanguard Knee System with conventional Instruments

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more of the knee compartments are involved
* correction of varus, valgus or posttraumatic deformity
* correction or revision of unsuccessful osteotomy (wedge cut from bone to improve alignment), or arthrodesis (fusion)
* need to obtain pain relief and improve function
* ability and willingness to follow instructions, including control of weight and activity level.
* a good nutritional state
* must have reached full skeletal maturity
* able and willing to undergo an MRI scan

Exclusion Criteria

* infection
* sepsis
* osteomyelitis
* failure of a previous joint replacement
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zimmer Biomet

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gordon Morrison, MBChB

Role: PRINCIPAL_INVESTIGATOR

The Queen Elizabeth Hospital

Locations

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Insall Scott Kelly Institute

New York, New York, United States

Site Status

Logan Hospital

Brisbane, Queensland, Australia

Site Status

The Queen Elizabeth Hospital

Adelaide, South Australia, Australia

Site Status

General Hospital Kreuzschwestern

Grieskirchen, Wels, Austria

Site Status

The Orthopaedic Hospital Speising

Vienna, , Austria

Site Status

St Luc General Hospital

Brussels, , Belgium

Site Status

Aalborg University Hospital

Aalborg, , Denmark

Site Status

Medipole de Savoie

Chambéry, , France

Site Status

Amphia Ziekenhuis Breda

Breda, , Netherlands

Site Status

Torres Verdras Hospital

Torres Vedras, Lisbon District, Portugal

Site Status

Danderyd Hospital

Stockholm, , Sweden

Site Status

Addenbrooke's Hospital

Cambridge, , United Kingdom

Site Status

Countries

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United States Australia Austria Belgium Denmark France Netherlands Portugal Sweden United Kingdom

Other Identifiers

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GBMET.CR.G4

Identifier Type: -

Identifier Source: org_study_id

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