VISIONAIRE™ Value Study
This study has been completed.
Information provided by (Responsible Party):
Smith & Nephew, Inc.
First received: April 9, 2010
Last updated: November 18, 2011
Last verified: November 2011
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.
Osteoarthritis of the Knee
||Observational Model: Cohort
Time Perspective: Prospective
||A Single-center, Randomized, Value Study of VISIONAIRE™ Patient Matched Technology vs. Standard Surgical Instrumentation
Primary Outcome Measures:
- Health Economic Criteria [ Time Frame: Up to 6 weeks ] [ Designated as safety issue: No ]
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
Secondary Outcome Measures:
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||February 2011 (Final data collection date for primary outcome measure)
Total knee arthroplasty with VISIONAIRE™ patient-matched cutting blocks
Total knee arthroplasty with standard instrumentation
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.
|Ages Eligible for Study:
||18 Years and older (Adult, Senior)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
The patient population considered for this study includes patients with osteoarthritis (degenerative joint disease)of the knee requiring unilateral TKA.
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.
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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01107769
|John Noble, Jr.
|Lake Charles, Louisiana, United States, 70605 |
Smith & Nephew, Inc.
||John Noble, Jr, M.D.
||Center for Orthopaedics Lake Charles, LA
J Arthroplasty. 2011 Sep 9. [Epub ahead of print] http://www.ncbi.nlm.nih.gov/pubmed/21908169
||Smith & Nephew, Inc.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||April 9, 2010
||November 18, 2011
||United States: Institutional Review Board
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 28, 2016