Arthroplasty, Replacement, KneeNCT01092312
Signature Personalised Patient Care System With the Vanguard Knee System Study
A study testing Vanguard Knee System with Signature Knee Guide and Vanguard Knee System with conventional Instruments in people with Arthroplasty, Replacement, Knee, run by Zimmer Biomet at 12 sites in 10 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthroplasty, Replacement, Knee
- What is being tested?
- Vanguard Knee System with Signature Knee Guide and Vanguard Knee System with conventional Instruments
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 325 participants
- Where
- 12 sitesin 10 countries
- Study dates
- Mar 2010to Sep 2016
- 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
- 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
Who cannot join
- infection
- sepsis
- osteomyelitis
- failure of a previous joint replacement
Trial locations and contacts
12 sites in 10 countries.
12 sites in 10 countries
Australia2 sites
The Queen Elizabeth Hospital
Adelaide, South Australia, 5011
Logan Hospital
Brisbane, Queensland, 4131
Austria2 sites
General Hospital Kreuzschwestern
Grieskirchen, Wels
The Orthopaedic Hospital Speising
Vienna
United States1 site
Insall Scott Kelly Institute
New York, New York, 10065
About this study
Official title: Study on the Signature Personalised Patient Care System With the Vanguard Knee System
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.
Read the detailed description
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
- Arthroplasty, Replacement, Knee
- Being tested
- Vanguard Knee System with Signature Knee Guide, Vanguard Knee System with conventional Instruments
- Keywords
- knee, arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vanguard Knee System with Signature Knee GuideProcedure or surgery
Use of Signature Knee Guide
Vanguard Knee System with conventional InstrumentsProcedure or surgery
Vanguard Knee System with conventional Instruments
| Study group | Role | What they receive |
|---|---|---|
| Signature Knee Guide | Experimental | Vanguard Knee System with Signature Knee Guide Receives: Procedure: Vanguard Knee System with Signature Knee Guide |
| Conventional Approach | Active comparator | Vanguard Complete Knee System with Conventional Approach Receives: Procedure: Vanguard Knee System with conventional Instruments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mechanical Axial Alignment
Femoral and tibial component alignment, femoral and tibial rotational alignment, tibial posterior slope
Measured: Prior to Discharge: 0-2 weeks
Secondary outcomes (1)
Clinical Outcome
American Knee Society Score, Oxford Knee Score
Measured: 6 months, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionSep 2016
- Study completionSep 2016
Why it stopped: No difference in outcome between the two groups
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroplasty, Replacement, KneeStudies 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
- 325 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gordon Morrison, MBChB, Principal investigator, The Queen Elizabeth Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01092312
- Sponsor's protocol ID
- GBMET.CR.G4
- Status last verified
- Aug 2017
- First submitted
- 7 Mar 2010
- Last updated
- 5 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Signature Personalised Patient Care System With the Vanguard Knee System
- ClinicalTrials.gov ID
- NCT01092312
- Acronym / sponsor ID
- GBMET.CR.G4
- Conditions
- Arthroplasty, Replacement, Knee
- Keywords
- knee, arthroplasty
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No difference in outcome between the two groups
- Enrolment
- 325 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- Mar 2010 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 24 Mar 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.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Signature Knee Guide | Experimental | Procedure: Vanguard Knee System with Signature Knee GuideVanguard Knee System with Signature Knee Guide |
| Conventional Approach | Active comparator | Procedure: Vanguard Knee System with conventional InstrumentsVanguard Complete Knee System with Conventional Approach |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (4 listed)
- infection
- sepsis
- osteomyelitis
- failure of a previous joint replacement
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 |
|---|---|---|
| Vanguard Knee System with Signature Knee GuideUse of Signature Knee Guide | Procedure or surgery | Signature Knee Guide |
| Vanguard Knee System with conventional InstrumentsVanguard Knee System with conventional Instruments | Procedure or surgery | Conventional Approach |
Primary outcome
Mechanical Axial Alignment
Time frame: Prior to Discharge: 0-2 weeks
Femoral and tibial component alignment, femoral and tibial rotational alignment, tibial posterior slope
1 secondary outcome
Clinical Outcome
Time frame: 6 months, 1 year
Results and safety
The study was stopped early (reason given: No difference in outcome between the two groups). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2017.
Related trials for Arthroplasty, Replacement, Knee
RecruitingPhase 3
REGN7508 Versus Apixaban and Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty in Adults
Venous Thromboembolism (VTE)
Recruiting
SII Levels Following iPACK Block With Adductor Canal Block in Knee Arthroplasty
Knee Osteoarthritis
Enrolling by invitationObservational study
Persona SoluTion PPS Femur PMCF
Rhematoid Arthritis, Osteo Arthritis of the Knee
Recruiting
ACB and iPACK Blocks With Intravenous Dexamethasone and Perineural Dexmedetomidine in Total Knee Arthroplasty
Knee Osteoarthritis
RecruitingPhase 3
REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants
Symptomatic Venous Thromboembolism (VTE)
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.
Gordon Morrison, MBChB principal investigator
The Queen Elizabeth Hospital
12 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vanguard Knee System with Signature Knee Guide and Vanguard Knee System with conventional Instruments in people with Arthroplasty, Replacement, Knee, run by Zimmer Biomet at 12 sites in 10 countries.
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 8 inclusion and 4 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: stopped early, as of the sponsor's last update on 5 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Australia, Austria, United States, Belgium, Denmark and 5 more countries. 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 was stopped early (reason given: No difference in outcome between the two groups). Results are not available in the source record.
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: Prior to Discharge: 0-2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Sep 2017.