OsteoarthritisNCT01937572
Visionaire: A Prospective Study
A study testing Visionaire system (Knee MRI) and No Knee MRI in people with Osteoarthritis, run by The Hawkins Foundation at 1 site in United States.
Trial summary
The purpose of the current study is to validate the technology of MRI-based alignment for total knee replacements and to collect data on potential advantages of the computer aided system. 1. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Visionaire system (Knee MRI) and No Knee MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 149 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Feb 2017
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients with sufficient symptoms from articular knee pathology to be an appropriate candidate for TKA
Who cannot join
- prior TKA
- ipsilateral upper tibial or distal femoral osteotomy
- ipsilateral total hip arthroplasty
- patient with significant >15o varus or valgus
- morbid obesity or those patients unable to have an MRI based on thigh circumference (22 cm or less)
Trial locations and contacts
1 site in 1 country.
United States1 site
Steadman Hawkins Clinic of the Carolinas - Greenville Hospital System
Greenville, South Carolina, 29615
About this study
Official title: Visionaire Versus Conventional Knee Arthroplasty: A Prospective Study
The purpose of the current study is to validate the technology of MRI-based alignment for total knee replacements and to collect data on potential advantages of the computer aided system.
- It is hypothesized that there will be no significant differences in position, loosening, or function of the Visionaire total knee as compared to the conventional total knee.
- It is hypothesized that the Visionaire total knee will be significantly better with regard to operative time, tourniquet time, blood loss, and procedural set-up, turnover time, and overall costs.
- Conditions
- Osteoarthritis
- Being tested
- Visionaire system (Knee MRI), No Knee MRI
- Keywords
- Total knee arthroplasty (TKA), Computer aided systems
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visionaire system (Knee MRI)Other
Also called Visionaire
No Knee MRIOther
| Study group | Role | What they receive |
|---|---|---|
| Computer-aided TKA | Experimental | The Visionaire system is a computer-aided system utilizing MRI of the knee prior to TKA surgeries. This technology achieves accurate rotational and A-P position. All of the commonly-referred anatomical landmarks (AP axis, epicondylar axis) are analyzed pre-operatively, allowing for the proper positioning of the implant for each patient. Receives: Other: Visionaire system (Knee MRI) |
| Conventional TKA | Other | A conventional TKA utilizes a jig system based on either intra-medullary or extra-medullary guides. No knee MRI is utilized for a conventional TKA. Receives: Other: No Knee MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Society Score
Measured: one year
Secondary outcomes (1)
Degrees off normal AP and lateral alignment
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2013 (estimated)
- Study startNov 2011
- Primary completionFeb 2017
- Study completionFeb 2017
Why it stopped: An interim analysis found the study would not be able to reach significance without a large increase in subjects which was not feasible.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hawkins Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brian Burnikel, MD, Principal investigator, Steadman Hawkins Clinic of the Carolinas - Greenville Hospital System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01937572
- Sponsor's protocol ID
- Pro00013735
- Status last verified
- Jul 2018
- First submitted
- 28 Aug 2013
- Last updated
- 5 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visionaire Versus Conventional Knee Arthroplasty: A Prospective Study
- ClinicalTrials.gov ID
- NCT01937572
- Acronym / sponsor ID
- Pro00013735
- Conditions
- Osteoarthritis
- Keywords
- Total knee arthroplasty (TKA), Computer aided systems
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: An interim analysis found the study would not be able to reach significance without a large increase in subjects which was not feasible.
- Enrolment
- 149 participants (actual)
- Lead sponsor
- The Hawkins FoundationUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 9 Sep 2013 (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 the current study is to validate the technology of MRI-based alignment for total knee replacements and to collect data on potential advantages of the computer aided system.
- It is hypothesized that there will be no significant differences in position, loosening, or function of the Visionaire total knee as compared to the conventional total knee.
- It is hypothesized that the Visionaire total knee will be significantly better with regard to operative time, tourniquet time, blood loss, and procedural set-up, turnover time, and overall costs.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Computer-aided TKA | Experimental | Other: Visionaire system (Knee MRI)The Visionaire system is a computer-aided system utilizing MRI of the knee prior to TKA surgeries. This technology achieves accurate rotational and A-P position. All of the commonly-referred anatomical landmarks (AP axis, epicondylar axis) are analyzed pre-operatively, allowing for the proper positioning of the implant for each patient. |
| Conventional TKA | Other | Other: No Knee MRIA conventional TKA utilizes a jig system based on either intra-medullary or extra-medullary guides. No knee MRI is utilized for a conventional TKA. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients with sufficient symptoms from articular knee pathology to be an appropriate candidate for TKA
Key exclusion criteria (5 listed)
- prior TKA
- ipsilateral upper tibial or distal femoral osteotomy
- ipsilateral total hip arthroplasty
- patient with significant >15o varus or valgus
- morbid obesity or those patients unable to have an MRI based on thigh circumference (22 cm or less)
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 |
|---|---|---|
| Visionaire system (Knee MRI)Also: Visionaire | Other | Computer-aided TKA |
| No Knee MRI | Other | Conventional TKA |
Primary outcome
Knee Society Score
Time frame: one year
1 secondary outcome
Degrees off normal AP and lateral alignment
Time frame: one year
Results and safety
The study was stopped early (reason given: An interim analysis found the study would not be able to reach significance without a large increase in subjects which was not feasible.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2018.
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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.
Brian Burnikel, MD principal investigator
Steadman Hawkins Clinic of the Carolinas - Greenville Hospital System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Visionaire system (Knee MRI) and No Knee MRI in people with Osteoarthritis, run by The Hawkins Foundation 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 1 inclusion and 5 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 Jul 2018. 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 was stopped early (reason given: An interim analysis found the study would not be able to reach significance without a large increase in subjects which was not feasible.). 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?
Knee Society Score (time frame: one year). 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 Jul 2018; AzTrials last refreshed its copy on 27 Oct 2026.