Study Stopped
An interim analysis found the study would not be able to reach significance without a large increase in subjects which was not feasible.
Visionaire: A Prospective Study
Visionaire Versus Conventional Knee Arthroplasty: A Prospective Study
1 other identifier
interventional
149
1 country
1
Brief 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.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.
- 2.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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2011
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2011
CompletedFirst Submitted
Initial submission to the registry
August 28, 2013
CompletedFirst Posted
Study publicly available on registry
September 9, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2017
CompletedJuly 5, 2018
July 1, 2018
5.3 years
August 28, 2013
July 2, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Knee Society Score
one year
Secondary Outcomes (1)
Degrees off normal AP and lateral alignment
one year
Other Outcomes (4)
Total blood loss
two days
Operative time
one day
Operative room setup and turnover times
one day
- +1 more other outcomes
Study Arms (2)
Computer-aided TKA
EXPERIMENTALThe 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
OTHERA conventional TKA utilizes a jig system based on either intra-medullary or extra-medullary guides. No knee MRI is utilized for a conventional TKA.
Interventions
Eligibility Criteria
You may qualify if:
- Adult patients with sufficient symptoms from articular knee pathology to be an appropriate candidate for TKA
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Steadman Hawkins Clinic of the Carolinas - Greenville Hospital System
Greenville, South Carolina, 29615, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Brian Burnikel, MD
Steadman Hawkins Clinic of the Carolinas - Greenville Hospital System
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 28, 2013
First Posted
September 9, 2013
Study Start
November 1, 2011
Primary Completion
February 1, 2017
Study Completion
February 1, 2017
Last Updated
July 5, 2018
Record last verified: 2018-07