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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01145157




Registration number
NCT01145157
Ethics application status
Date submitted
15/06/2010
Date registered
16/06/2010

Titles & IDs
Public title
A Comparison Between Signature Total Knee Arthroplasty (TKA) to Conventional TKA and Computer Assisted TKA
Scientific title
A Comparison Between 'Signature™ Personalised Patient Care' to Conventional Total Knee Arthroplasty and Computer Assisted Navigation and a Cost Benefit Analysis for the Australian Market
Secondary ID [1] 0 0
BMET AU03 (INT.CR.LAU3)
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Joint Disease 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Signature Knee Guide
Treatment: Devices - Conventional Instrumentation
Treatment: Devices - Computer Assisted Navigation

Experimental: Signature Knee Guide - Total Knee Arthroplasty using the Signature Knee Guide with the Vanguard Knee System

Active comparator: Conventional Instrumentation - Total Knee Arthroplasty will be performed using Conventional Instrumentation with the Vanguard Knee System

Active comparator: Computer Assisted Navigation - Total Knee Arthroplasty will be performed using Computer Assisted Navigation with the Vanguard Knee System


Treatment: Devices: Signature Knee Guide
Total Knee Arthroplasty performed using Signature Knee Guide

Treatment: Devices: Conventional Instrumentation
Total Knee Arthroplasty performed using Conventional Instrumentation

Treatment: Devices: Computer Assisted Navigation
Total Knee Arthroplasty performed using Computer Assisted Navigation
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mechanical Axial Alignment
Timepoint [1] 0 0
Six months post-operative
Secondary outcome [1] 0 0
Functional outcomes - Knee Society Score
Timepoint [1] 0 0
One year post-operative

Eligibility
Key inclusion criteria
* Patient is of legal age and skeletally mature
* Patient requires primary total knee arthroplasty due to non- inflammatory degenerative joint disease (e.g. osteoarthritis, traumatic arthritis, a vascular necrosis, dysplasia/DDH) or inflammatory joint disease (e.g., Rheumatoid arthritis).
* Patient has met an acceptable preoperative medical clearance and is free from or treated for cardiac, pulmonary, haematological, etc., conditions that would pose excessive operative risk
* The patient will be available for follow up throughout the duration of the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Patient is unable to have an MRI scan due to the following conditions:

* Cardiac pacemaker
* Surgical clips in head (aneurysm clips)
* Some artificial heart valves
* Electronic inner ear implants
* Metal fragments in eyes
* Electronic stimulators
* Implanted pumps
* Patient has active infection or sepsis (treated or untreated)
* Patient has any vascular insufficiency, muscular atrophy, or neuromuscular disease severe enough to compromise implant stability or postoperative recovery.
* Patient is female of child-bearing age and not taking contraceptive precautions.
* Patient has inadequate bone stock to support the device (e.g. severe osteopenia, family history of severe osteoporosis or osteopenia).
* Patient has known moderate to severe renal insufficiency.
* Patient has a known or suspected metal sensitivity.
* Patient is immunosuppressed or receiving high doses of corticosteroids.
* Patient has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study including mental illness, mental retardation, or drug, alcohol abuse.
* Patient has BMI >40.

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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2015
Sample size
Target
Accrual to date
Final
150
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Repatriation General Hospital (RGH) - Daw Park
Recruitment postcode(s) [1] 0 0
5041 - Daw Park

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jegan Krishnan
Address 0 0
Flinders Medical Centre
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
There is no plan to share Individual Patient Data


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT01145157