Joint DiseaseNCT01145157
A Comparison Between Signature Total Knee Arthroplasty (TKA) to Conventional TKA and Computer Assisted TKA
A study testing Signature Knee Guide, Conventional Instrumentation and Computer Assisted Navigation in people with Joint Disease, run by Zimmer Biomet at 1 site in Australia.
Trial summary
This is a prospective, randomised clinical outcomes study comparing the Signature Personalised Patient Care, Conventional Total Knee Arthroplasty and Computer Assisted Navigation, using Vanguard Knee System. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Joint Disease
- What is being tested?
- Signature Knee Guide, Conventional Instrumentation and Computer Assisted Navigation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteAustralia
- Study dates
- Jul 2010to Feb 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 17Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Australia1 site
Repatriation General Hospital (RGH)
Daw Park, South Australia, 5041
About this study
Official 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
This is a prospective, randomised clinical outcomes study comparing the Signature Personalised Patient Care, Conventional Total Knee Arthroplasty and Computer Assisted Navigation, using Vanguard Knee System. The aim of the study is to evaluate the safety and efficacy of TKA using Signature Personalised Patient Care compared to Conventional TKA and Computer Assisted Navigation.
Read the detailed description
The objective of this study is to report and compare on the outcomes from patients undergoing total knee arthroplasty utilizing 'SignatureTM Personalised Patient Care', Conventional Total Knee Arthroplasty and Computer Assisted Navigation.
The 'SignatureTM Personalised Patient Care' is a system that uses a patient's Magnetic Resonance Imaging (MRI) and X-ray design to build surgical instruments customized for a patient's unique knee anatomy. Cutting positioning guides are produced to match the outer shape of the individual's distal femur and proximal tibia.
The cutting positioning guides are intended to be used as patient-specific surgical instrumentation to assist in the positioning of total knee replacement components intra-operatively and in guiding the marking of bone before cutting.
- Conditions
- Joint Disease
- Being tested
- Signature Knee Guide, Conventional Instrumentation, Computer Assisted Navigation
- Keywords
- knee, arthroplasty
- Medical subject headings
- Joint Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Signature Knee GuideDevice
Total Knee Arthroplasty performed using Signature Knee Guide
Conventional InstrumentationDevice
Total Knee Arthroplasty performed using Conventional Instrumentation
Computer Assisted NavigationDevice
Total Knee Arthroplasty performed using Computer Assisted Navigation
| Study group | Role | What they receive |
|---|---|---|
| Signature Knee Guide | Experimental | Total Knee Arthroplasty using the Signature Knee Guide with the Vanguard Knee System Receives: Device: Signature Knee Guide |
| Conventional Instrumentation | Active comparator | Total Knee Arthroplasty will be performed using Conventional Instrumentation with the Vanguard Knee System Receives: Device: Conventional Instrumentation |
| Computer Assisted Navigation | Active comparator | Total Knee Arthroplasty will be performed using Computer Assisted Navigation with the Vanguard Knee System Receives: Device: Computer Assisted Navigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mechanical Axial Alignment
The primary radiological outcome will be tibial rotation
Measured: Six months post-operative
Secondary outcomes (1)
Functional outcomes - Knee Society Score
The Knee Score consists of points given for pain, range of motion, and stability in both the coronal and sagittal planes, with deductions for fixed deformity, and extensor lag. The Function Score consists of points given for the ability to walk on level surfaces, and the ability to ascend and descend stairs, with deductions for the use of external supporting devices.
Measured: One year post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2010 (estimated)
- Study startJul 2010
- Primary completionDec 2014
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Joint DiseaseStudies of the same condition, open and under way.
- More trials run by Zimmer BiometThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jegan Krishnan, Principal investigator, Flinders Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01145157
- Sponsor's protocol ID
- BMET AU03 (INT.CR.LAU3)
- Status last verified
- Aug 2017
- First submitted
- 15 Jun 2010
- Last updated
- 2 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: There is no plan to share Individual Patient Data
Publications
Cundy WJ, Theodoulou A, Ling CM, Krishnan J, Wilson CJ. Blood Loss in Total Knee Arthroplasty. J Knee Surg. 2017 Jun;30(5):452-459. doi: 10.1055/s-0036-1592147. Epub 2016 Sep 21.
PubMed 27652687
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT01145157
- Acronym / sponsor ID
- BMET AU03 (INT.CR.LAU3)
- Conditions
- Joint Disease
- Keywords
- knee, arthroplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Dec 2014 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 16 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, randomised clinical outcomes study comparing the Signature Personalised Patient Care, Conventional Total Knee Arthroplasty and Computer Assisted Navigation, using Vanguard Knee System. The aim of the study is to evaluate the safety and efficacy of TKA using Signature Personalised Patient Care compared to Conventional TKA and Computer Assisted Navigation.
Detailed description
The objective of this study is to report and compare on the outcomes from patients undergoing total knee arthroplasty utilizing 'SignatureTM Personalised Patient Care', Conventional Total Knee Arthroplasty and Computer Assisted Navigation.
The 'SignatureTM Personalised Patient Care' is a system that uses a patient's Magnetic Resonance Imaging (MRI) and X-ray design to build surgical instruments customized for a patient's unique knee anatomy. Cutting positioning guides are produced to match the outer shape of the individual's distal femur and proximal tibia.
The cutting positioning guides are intended to be used as patient-specific surgical instrumentation to assist in the positioning of total knee replacement components intra-operatively and in guiding the marking of bone before cutting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Signature Knee Guide | Experimental | Device: Signature Knee GuideTotal Knee Arthroplasty using the Signature Knee Guide with the Vanguard Knee System |
| Conventional Instrumentation | Active comparator | Device: Conventional InstrumentationTotal Knee Arthroplasty will be performed using Conventional Instrumentation with the Vanguard Knee System |
| Computer Assisted Navigation | Active comparator | Device: Computer Assisted NavigationTotal Knee Arthroplasty will be performed using Computer Assisted Navigation with the Vanguard Knee System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (17 listed)
- Patient is unable to have an MRI scan due to the following conditions:
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Signature Knee GuideTotal Knee Arthroplasty performed using Signature Knee Guide | Device | Signature Knee Guide |
| Conventional InstrumentationTotal Knee Arthroplasty performed using Conventional Instrumentation | Device | Conventional Instrumentation |
| Computer Assisted NavigationTotal Knee Arthroplasty performed using Computer Assisted Navigation | Device | Computer Assisted Navigation |
Primary outcome
Mechanical Axial Alignment
Time frame: Six months post-operative
The primary radiological outcome will be tibial rotation
1 secondary outcome
Functional outcomes - Knee Society Score
Time frame: One year post-operative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2017.
- Derived from this study: PubMed 27652687Cundy WJ, Theodoulou A, Ling CM, Krishnan J, Wilson CJ. Blood Loss in Total Knee Arthroplasty. J Knee Surg. 2017 Jun;30(5):452-459. doi: 10.1055/s-0036-1592147. Epub 2016 Sep 21.
- Individual participant dataSharing planned: No. There is no plan to share Individual Patient Data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jegan Krishnan principal investigator
Flinders Medical Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Signature Knee Guide, Conventional Instrumentation and Computer Assisted Navigation in people with Joint Disease, run by Zimmer Biomet at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mechanical Axial Alignment (time frame: Six months post-operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01145157, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2017.