Visionaire: A Prospective Study

Osteoarthritis Clinical Trial

Official title:

Visionaire Versus Conventional Knee Arthroplasty: A Prospective Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01937572
• Other study ID #: Pro00013735
• Status: Terminated
• Phase: N/A
• Start date: November 2011
• Est. completion date: February 2017

Study information

• Verified date: July 2018
• Source: The Hawkins Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 149
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Adult patients with sufficient symptoms from articular knee pathology to be an appropriate candidate for TKA

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Other:
• Visionaire system (Knee MRI)

• No Knee MRI

Locations

Country	Name	City	State
United States	Steadman Hawkins Clinic of the Carolinas - Greenville Hospital System	Greenville	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
The Hawkins Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Total blood loss		two days
Other	Operative time		one day
Other	Operative room setup and turnover times		one day
Other	Procedural cost		one day
Primary	Knee Society Score		one year
Secondary	Degrees off normal AP and lateral alignment		one year