VISIONAIRE™ Value Study

November 18, 2011 updated by: Smith & Nephew, Inc.

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

38

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Louisiana
      • Lake Charles, Louisiana, United States, 70605
        • John Noble, Jr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The patient population considered for this study includes patients with osteoarthritis (degenerative joint disease)of the knee requiring unilateral TKA.

Description

Inclusion Criteria:

Patients must meet all of the inclusion criteria.

  1. Patient is diagnosed with degenerative joint disease of the knee requiring a unilateral TKA.
  2. Patient is of legal age to consent, and is skeletally mature.
  3. Patient is willing to sign and date an IRB/IEC approved consent form.

Exclusion Criteria:

Patients must not meet any of the exclusion criteria.

  1. Patient has poor bone stock making a TKA unjustifiable.
  2. Patient has active, local infection or previous intra-articular infections.
  3. Patient has neuropathic (Charcot) joint.
  4. Patient is pregnant or may become pregnant during the course of the study.
  5. Patient is severely overweight (BMI >40).
  6. Patient is a prisoner.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
VISIONAIRE™
Total knee arthroplasty with VISIONAIRE™ patient-matched cutting blocks
Standard Instrumentation
Total knee arthroplasty with standard instrumentation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with Adverse Events as a measure of Safety and Tolerability
Time Frame: Perioperative & Postoperative (up to 6 weeks)
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.
Perioperative & Postoperative (up to 6 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Smith & Nephew, Inc.

Investigators

  • Principal Investigator: John Noble, Jr, M.D., Center for Orthopaedics Lake Charles, LA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

February 1, 2011

Study Registration Dates

First Submitted

April 9, 2010

First Submitted That Met QC Criteria

April 20, 2010

First Posted (Estimate)

April 21, 2010

Study Record Updates

Last Update Posted (Estimate)

November 21, 2011

Last Update Submitted That Met QC Criteria

November 18, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VISVAL01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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