Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01092312




Registration number
NCT01092312
Ethics application status
Date submitted
7/03/2010
Date registered
24/03/2010
Date last updated
5/09/2017

Titles & IDs
Public title
Signature Personalised Patient Care System With the Vanguard Knee System Study
Scientific title
Study on the Signature Personalised Patient Care System With the Vanguard Knee System
Secondary ID [1] 0 0
GBMET.CR.G4
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Arthroplasty, Replacement, Knee 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Vanguard Knee System with Signature Knee Guide
Treatment: Surgery - Vanguard Knee System with conventional Instruments

Experimental: Signature Knee Guide - Vanguard Knee System with Signature Knee Guide

Active Comparator: Conventional Approach - Vanguard Complete Knee System with Conventional Approach


Treatment: Surgery: Vanguard Knee System with Signature Knee Guide
Use of Signature Knee Guide

Treatment: Surgery: Vanguard Knee System with conventional Instruments
Vanguard Knee System with conventional Instruments
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mechanical Axial Alignment
Timepoint [1] 0 0
Prior to Discharge: 0-2 weeks
Secondary outcome [1] 0 0
Clinical Outcome
Timepoint [1] 0 0
6 months, 1 year

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- infection

- sepsis

- osteomyelitis

- failure of a previous joint replacement

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2016
Sample size
Target
Accrual to date
Final
325
Recruitment in Australia
Recruitment state(s)
QLD,SA
Recruitment hospital [1] 0 0
Logan Hospital - Brisbane
Recruitment hospital [2] 0 0
The Queen Elizabeth Hospital - Adelaide
Recruitment postcode(s) [1] 0 0
4131 - Brisbane
Recruitment postcode(s) [2] 0 0
5011 - Adelaide
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
New York
Country [2] 0 0
Austria
State/province [2] 0 0
Wels
Country [3] 0 0
Austria
State/province [3] 0 0
Vienna
Country [4] 0 0
Belgium
State/province [4] 0 0
Brussels
Country [5] 0 0
Denmark
State/province [5] 0 0
Aalborg
Country [6] 0 0
France
State/province [6] 0 0
Chambery
Country [7] 0 0
Netherlands
State/province [7] 0 0
Breda
Country [8] 0 0
Portugal
State/province [8] 0 0
Lisbon
Country [9] 0 0
Sweden
State/province [9] 0 0
Stockholm
Country [10] 0 0
United Kingdom
State/province [10] 0 0
Cambridge

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Zimmer Biomet
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01092312
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Gordon Morrison, MBChB
Address 0 0
The Queen Elizabeth Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01092312