Signature Personalised Patient Care System With the Vanguard Knee System Study
NCT ID: NCT01092312
Last Updated: 2017-09-05
Study Results
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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TERMINATED
NA
325 participants
INTERVENTIONAL
2010-03-31
2016-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Signature Knee Guide
Vanguard Knee System with Signature Knee Guide
Vanguard Knee System with Signature Knee Guide
Use of Signature Knee Guide
Conventional Approach
Vanguard Complete Knee System with Conventional Approach
Vanguard Knee System with conventional Instruments
Vanguard Knee System with conventional Instruments
Interventions
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Vanguard Knee System with Signature Knee Guide
Use of Signature Knee Guide
Vanguard Knee System with conventional Instruments
Vanguard Knee System with conventional Instruments
Eligibility Criteria
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Inclusion Criteria
* 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
* sepsis
* osteomyelitis
* failure of a previous joint replacement
18 Years
ALL
No
Sponsors
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Zimmer Biomet
INDUSTRY
Responsible Party
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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
Logan Hospital
Brisbane, Queensland, Australia
The Queen Elizabeth Hospital
Adelaide, South Australia, Australia
General Hospital Kreuzschwestern
Grieskirchen, Wels, Austria
The Orthopaedic Hospital Speising
Vienna, , Austria
St Luc General Hospital
Brussels, , Belgium
Aalborg University Hospital
Aalborg, , Denmark
Medipole de Savoie
Chambéry, , France
Amphia Ziekenhuis Breda
Breda, , Netherlands
Torres Verdras Hospital
Torres Vedras, Lisbon District, Portugal
Danderyd Hospital
Stockholm, , Sweden
Addenbrooke's Hospital
Cambridge, , United Kingdom
Countries
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Other Identifiers
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GBMET.CR.G4
Identifier Type: -
Identifier Source: org_study_id
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