Osteoarthritis of the KneePhase 3VisionaireNCT01224522
Axial Alignment in Patients Operated Using the Visionaire Patient Matched Cutting Blocks
A Phase 3 study testing Visionaire and Standard surgical technique in people with Osteoarthritis of the Knee, run by Smith & Nephew Orthopaedics AG at 1 site in United Kingdom.
Trial summary
Title: PATIENT-MATCHED INSTRUMENTATION VS. STANDARD INSTRUMENTATION: A RANDOMIZED CLINICAL TRIAL COMPARING POSTOPERATIVE AXIAL ALIGNMENT and COMPONENT POSITION Short Title: Visionaire Alignment Methodology: Monocentric, Single Blinded, Randomized Controlled Trial Study Duration: November 2010 to July 2014 Study… Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Osteoarthritis of the Knee
- What is being tested?
- Visionaire and Standard surgical technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2011to Aug 2014
- Phase
- Phase 3
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Indication for TKA, Axial alignment between 10 degrees valgus and 20 degrees varus, BMI <36, patient must be amendable for both Genesis II total knee and Visioniare cutting blocks
Who cannot join
- Insufficient femoral or tibia bone stock, inflammatory arthritis (e.g. rheumatoid arthritis), patient is immunosuppressed, has an active infection (local or systemic), patient has physical, emotional or neurological conditions that would compromise the patients compliance with rehabilitation and follow up.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PATIENT-MATCHED INSTRUMENTATION Versus (vs) STANDARD INSTRUMENTATION: A RANDOMIZED CLINICAL TRIAL COMPARING POSTOPERATIVE AXIAL ALIGNMENT and COMPONENT POSITION
- Title: PATIENT-MATCHED INSTRUMENTATION VS. STANDARD INSTRUMENTATION: A RANDOMIZED CLINICAL TRIAL COMPARING POSTOPERATIVE AXIAL ALIGNMENT and COMPONENT POSITION
- Short Title: Visionaire Alignment
- Methodology: Monocentric, Single Blinded, Randomized Controlled Trial
- Study Duration: November 2010 to July 2014
- Study Centres: Leicester General Hospital, United Kingdom (UK)
Read the detailed description
Malalignment is one of the main reasons for knee arthroplasty revision. With the use of patient matched cutting block we expect better axial alignment of the components.
Research Objectives:
- The primary research objective is to evaluate the axial alignment and component position in TKA with use of Smith \& Nephew's VISIONAIRE Patient Matched Technology and to compare with the alignment when standard instrumentation.
- Secondary research objectives include assessing the safety and effectiveness of the VISIONAIRE patient matched technology as compared to commonly accepted standard instrumentation in patients suffering from symptomatic osteoarthritis of the knee joint.
- Outcome Measures:
- Implant alignment and Component position by means of CT-scans
- Knee Society Score
- EuroQol-5 Dimensions (EQ-5D)
- Knee injury and Osteoarthritis Outcome Score (KOOS)
- Oxford Knee Score
- Knee-related adverse events
- Standard and full leg x-ray
- Number of Subjects: 70 (2*35)
- Enrollment time: 18 months
- Diagnosis and Main Inclusion Criteria: Patients with osteoarthritis of the knee requiring total knee arthroplasty
- Study Product, Dose, Route, Regimen:
VISIONAIRE patient matched technology versus the commonly accepted standard instrumentation for the Genesis II total knee arthroplasty implant
- Conditions
- Osteoarthritis of the Knee
- Being tested
- Visionaire, Standard surgical technique
- Keywords
- Randomized Controlled Trial, Total Knee Arthroplasty, Patient Matched Cutting Blocks
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VisionaireProcedure or surgery
Also called Standard Smith & Nephew instruments, Visionaire Instruments
Implantation of a Genesis II Total Knee by means of Visionaire patient matched cutting blocks.
Standard surgical techniqueProcedure or surgery
Implantation of Genesis II Total Knee system by means of standard surgical technique.
| Study group | Role | What they receive |
|---|---|---|
| Visionaire | Experimental | the group who will be operated by the use of Visionaire patient matched cutting blocks Receives: Procedure: Visionaire |
| Standard Surgical technique | Active comparator | The group who will be operated by means fo standard surgical technique Receives: Procedure: Standard surgical technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Axial Alignment
Axial alignment will be measured by means of CT scan and long leg x-ray
Measured: 6 weeks,
Secondary outcomes (1)
Clinical effectiveness and safety.
Safety and effectiveness will be measured by means of Knee Society Score, Oxford Score, EQ-5D and radiographic findings
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2010 (estimated)
- Study startMar 2011
- Primary completionAug 2014
- Study completionAug 2014
Why it stopped: protocol deviations
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis of the KneeStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smith & Nephew Orthopaedics AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Urjit Chatterji, MD, Principal investigator, Leicester General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01224522
- Sponsor's protocol ID
- R11025-2
- Acronym
- Visionaire
- Status last verified
- Apr 2015
- First submitted
- 14 Oct 2010
- Last updated
- 14 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PATIENT-MATCHED INSTRUMENTATION Versus (vs) STANDARD INSTRUMENTATION: A RANDOMIZED CLINICAL TRIAL COMPARING POSTOPERATIVE AXIAL ALIGNMENT and COMPONENT POSITION
- ClinicalTrials.gov ID
- NCT01224522
- Acronym / sponsor ID
- Visionaire / R11025-2
- Conditions
- Osteoarthritis of the Knee
- Keywords
- Randomized Controlled Trial, Total Knee Arthroplasty, Patient Matched Cutting Blocks
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: protocol deviations
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Smith & Nephew Orthopaedics AGIndustry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 20 Oct 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.
- Title: PATIENT-MATCHED INSTRUMENTATION VS. STANDARD INSTRUMENTATION: A RANDOMIZED CLINICAL TRIAL COMPARING POSTOPERATIVE AXIAL ALIGNMENT and COMPONENT POSITION
- Short Title: Visionaire Alignment
- Methodology: Monocentric, Single Blinded, Randomized Controlled Trial
- Study Duration: November 2010 to July 2014
- Study Centres: Leicester General Hospital, United Kingdom (UK)
Detailed description
Malalignment is one of the main reasons for knee arthroplasty revision. With the use of patient matched cutting block we expect better axial alignment of the components.
Research Objectives:
- The primary research objective is to evaluate the axial alignment and component position in TKA with use of Smith \& Nephew's VISIONAIRE Patient Matched Technology and to compare with the alignment when standard instrumentation.
- Secondary research objectives include assessing the safety and effectiveness of the VISIONAIRE patient matched technology as compared to commonly accepted standard instrumentation in patients suffering from symptomatic osteoarthritis of the knee joint.
- Outcome Measures:
- Implant alignment and Component position by means of CT-scans
- Knee Society Score
- EuroQol-5 Dimensions (EQ-5D)
- Knee injury and Osteoarthritis Outcome Score (KOOS)
- Oxford Knee Score
- Knee-related adverse events
- Standard and full leg x-ray
- Number of Subjects: 70 (2*35)
- Enrollment time: 18 months
- Diagnosis and Main Inclusion Criteria: Patients with osteoarthritis of the knee requiring total knee arthroplasty
- Study Product, Dose, Route, Regimen:
VISIONAIRE patient matched technology versus the commonly accepted standard instrumentation for the Genesis II total knee arthroplasty implant
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Visionaire | Experimental | Procedure: Visionairethe group who will be operated by the use of Visionaire patient matched cutting blocks |
| Standard Surgical technique | Active comparator | Procedure: Standard surgical techniqueThe group who will be operated by means fo standard surgical technique |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Indication for TKA, Axial alignment between 10 degrees valgus and 20 degrees varus, BMI <36, patient must be amendable for both Genesis II total knee and Visioniare cutting blocks
Key exclusion criteria (1 listed)
- Insufficient femoral or tibia bone stock, inflammatory arthritis (e.g. rheumatoid arthritis), patient is immunosuppressed, has an active infection (local or systemic), patient has physical, emotional or neurological conditions that would compromise the patients compliance with rehabilitation and follow up.
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 |
|---|---|---|
| VisionaireAlso: Standard Smith & Nephew instruments, Visionaire InstrumentsImplantation of a Genesis II Total Knee by means of Visionaire patient matched cutting blocks. | Procedure or surgery | Visionaire |
| Standard surgical techniqueImplantation of Genesis II Total Knee system by means of standard surgical technique. | Procedure or surgery | Standard Surgical technique |
Primary outcome
Axial Alignment
Time frame: 6 weeks,
Axial alignment will be measured by means of CT scan and long leg x-ray
1 secondary outcome
Clinical effectiveness and safety.
Time frame: 1 year
Results and safety
The study was stopped early (reason given: protocol deviations). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2015.
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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.
Urjit Chatterji, MD principal investigator
Leicester General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Visionaire and Standard surgical technique in people with Osteoarthritis of the Knee, run by Smith & Nephew Orthopaedics AG at 1 site in United Kingdom.
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 1 inclusion and 1 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 14 Apr 2015. 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 United Kingdom. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: protocol deviations). 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?
Axial Alignment (time frame: 6 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 14 Apr 2015.