Osteoarthritis of the KneeNCT01107769
VISIONAIRE™ Value Study
An observational study of Osteoarthritis of the Knee, run by Smith & Nephew, Inc. at 1 site in United States.
Trial summary
This is a single center randomized observational study that evaluates the cost benefit ratio between the use of two types of instrumentation in TKA: standard instrumentation vs. VISIONAIRE™ Patient Matched Technology. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis of the Knee
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Feb 2011
- Phase
- Observational
- 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
Study population: The patient population considered for this study includes patients with osteoarthritis (degenerative joint disease)of the knee requiring unilateral TKA.
Who may be able to join
- Patients must meet all of the inclusion criteria.
- Patient is diagnosed with degenerative joint disease of the knee requiring a unilateral TKA.
- Patient is of legal age to consent, and is skeletally mature.
- Patient is willing to sign and date an IRB/IEC approved consent form.
Who cannot join
- Patients must not meet any of the exclusion criteria.
- Patient has poor bone stock making a TKA unjustifiable.
- Patient has active, local infection or previous intra-articular infections.
- Patient has neuropathic (Charcot) joint.
- Patient is pregnant or may become pregnant during the course of the study.
- Patient is severely overweight (BMI >40).
- Patient is a prisoner.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-center, Randomized, Value Study of VISIONAIRE™ Patient Matched Technology vs. Standard Surgical Instrumentation
This is a single center randomized observational study that evaluates the cost benefit ratio between the use of two types of instrumentation in TKA: standard instrumentation vs. VISIONAIRE™ Patient Matched Technology. This study does not involve treatment or investigational products, as all components are FDA approved and are commercially available.
Read the detailed description
The objective of the current observational study is to assess value of surgical instrumentation following analysis of health economic data. It is hypothesized that patient matched cutting block technology VISIONAIRE™ may reduce TKA operative time, blood loss, surgical error and adverse event risk as well as providing improved mechanical alignment. In order to test this hypothesis, subjects will be randomized to either VISIONAIRE™ or standard TKA instrumentation groups. One site will enroll a total of 38 patients; 19 patients per group. All patients meeting the inclusion/exclusion criteria specified in this protocol will be asked to participate in the study. If the patient consents to participate, they will be enrolled in the study and randomized to one of the two study arms. Patients requiring TKA will be implanted with Legion, Genesis II or Journey BCS (Smith \& Nephew) total knee implant systems. Standard instrumentation will be used to assist the surgeon in placing the implant in the control group. In the VISIONAIRE™ group, standard instrumentation will not be used in the surgery. Patients randomized to the VISIONAIRE™ arm will have an MRI preoperatively that will be used to create the customized cutting blocks. All patients will have an x-ray at each postoperative interval.
- Conditions
- Osteoarthritis of the Knee
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| VISIONAIRE™ | Total knee arthroplasty with VISIONAIRE™ patient-matched cutting blocks | |
| Standard Instrumentation | Total knee arthroplasty with standard instrumentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health Economic Criteria
This study will evaluate the cost benefit ratio between the use of two types of instrumentation in TKA: standard instrumentation vs. VISIONAIRE™. The following will be collected \& reported from the OR and discharge report:
- instrument tray set-up time
- operative time
- blood loss
- instrumentation requirements
- discharge disposition
- ambulatory support on discharge
- adverse event
Measured: Up to 6 weeks
Secondary outcomes (1)
Number of Participants with Adverse Events as a measure of Safety and Tolerability
Radiographic analysis will be conducted to assess preoperative and postoperative mechanical alignment between groups. All perioperative and postoperative surgical or instrument-related adverse events will be recorded during this study.
Measured: Perioperative & Postoperative (up to 6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smith & Nephew, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Noble, Jr, M.D., Principal investigator, Center for Orthopaedics Lake Charles, LA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01107769
- Sponsor's protocol ID
- VISVAL01
- Status last verified
- Nov 2011
- First submitted
- 9 Apr 2010
- Last updated
- 21 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
J Arthroplasty. 2011 Sep 9. [Epub ahead of print] http://www.ncbi.nlm.nih.gov/pubmed/21908169
Noble JW Jr, Moore CA, Liu N. The value of patient-matched instrumentation in total knee arthroplasty. J Arthroplasty. 2012 Jan;27(1):153-5. doi: 10.1016/j.arth.2011.07.006. Epub 2011 Sep 9.
PubMed 21908169
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Randomized, Value Study of VISIONAIRE™ Patient Matched Technology vs. Standard Surgical Instrumentation
- ClinicalTrials.gov ID
- NCT01107769
- Acronym / sponsor ID
- VISVAL01
- Conditions
- Osteoarthritis of the Knee
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Smith & Nephew, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 21 Apr 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 single center randomized observational study that evaluates the cost benefit ratio between the use of two types of instrumentation in TKA: standard instrumentation vs. VISIONAIRE™ Patient Matched Technology. This study does not involve treatment or investigational products, as all components are FDA approved and are commercially available.
Detailed description
The objective of the current observational study is to assess value of surgical instrumentation following analysis of health economic data. It is hypothesized that patient matched cutting block technology VISIONAIRE™ may reduce TKA operative time, blood loss, surgical error and adverse event risk as well as providing improved mechanical alignment. In order to test this hypothesis, subjects will be randomized to either VISIONAIRE™ or standard TKA instrumentation groups. One site will enroll a total of 38 patients; 19 patients per group. All patients meeting the inclusion/exclusion criteria specified in this protocol will be asked to participate in the study. If the patient consents to participate, they will be enrolled in the study and randomized to one of the two study arms. Patients requiring TKA will be implanted with Legion, Genesis II or Journey BCS (Smith \& Nephew) total knee implant systems. Standard instrumentation will be used to assist the surgeon in placing the implant in the control group. In the VISIONAIRE™ group, standard instrumentation will not be used in the surgery. Patients randomized to the VISIONAIRE™ arm will have an MRI preoperatively that will be used to create the customized cutting blocks. All patients will have an x-ray at each postoperative interval.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VISIONAIRE™ | – | –Total knee arthroplasty with VISIONAIRE™ patient-matched cutting blocks |
| Standard Instrumentation | – | –Total knee arthroplasty with standard instrumentation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patient population considered for this study includes patients with osteoarthritis (degenerative joint disease)of the knee requiring unilateral TKA.
Key inclusion criteria (4 listed)
- Patients must meet all of the inclusion criteria.
- Patient is diagnosed with degenerative joint disease of the knee requiring a unilateral TKA.
- Patient is of legal age to consent, and is skeletally mature.
- Patient is willing to sign and date an IRB/IEC approved consent form.
Key exclusion criteria (7 listed)
- Patients must not meet any of the exclusion criteria.
- Patient has poor bone stock making a TKA unjustifiable.
- Patient has active, local infection or previous intra-articular infections.
- Patient has neuropathic (Charcot) joint.
- Patient is pregnant or may become pregnant during the course of the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Health Economic Criteria
Time frame: Up to 6 weeks
This study will evaluate the cost benefit ratio between the use of two types of instrumentation in TKA: standard instrumentation vs. VISIONAIRE™. The following will be collected \& reported from the OR and discharge report: * instrument tray set-up time * operative time * blood loss * instrumentation requirements * discharge disposition * ambulatory support on discharge * adverse event
1 secondary outcome
Number of Participants with Adverse Events as a measure of Safety and Tolerability
Time frame: Perioperative & Postoperative (up to 6 weeks)
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 21 Nov 2011.
- Results publicationJ Arthroplasty. 2011 Sep 9. [Epub ahead of print] http://www.ncbi.nlm.nih.gov/pubmed/21908169
- Results publication: PubMed 21908169Noble JW Jr, Moore CA, Liu N. The value of patient-matched instrumentation in total knee arthroplasty. J Arthroplasty. 2012 Jan;27(1):153-5. doi: 10.1016/j.arth.2011.07.006. Epub 2011 Sep 9.
- The Value of Patient-Matched Instrumentation in Total Knee Arthroplasty.Link provided by the sponsor.
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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.
John Noble, Jr, M.D. principal investigator
Center for Orthopaedics Lake Charles, LA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis of the Knee, run by Smith & Nephew, Inc. at 1 site in United States.
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 7 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 21 Nov 2011. 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 States. 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?
Health Economic Criteria (time frame: Up to 6 weeks). 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 NCT01107769, which also lists 2 linked publications.
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 21 Nov 2011.