VISIONAIRE™ Value Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Smith & Nephew, Inc.
ClinicalTrials.gov Identifier:
NCT01107769
First received: April 9, 2010
Last updated: November 18, 2011
Last verified: November 2011
  Purpose

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.


Condition
Osteoarthritis of the Knee

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Single-center, Randomized, Value Study of VISIONAIRE™ Patient Matched Technology vs. Standard Surgical Instrumentation

Further study details as provided by Smith & Nephew, Inc.:

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:
  • Number of Participants with Adverse Events as a measure of Safety and Tolerability [ Time Frame: Perioperative & Postoperative (up to 6 weeks) ] [ Designated as safety issue: No ]
    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.


Enrollment: 38
Study Start Date: April 2010
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
VISIONAIRE™
Total knee arthroplasty with VISIONAIRE™ patient-matched cutting blocks
Standard Instrumentation
Total knee arthroplasty with standard instrumentation

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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.
  Contacts and Locations
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

Locations
United States, Louisiana
John Noble, Jr.
Lake Charles, Louisiana, United States, 70605
Sponsors and Collaborators
Smith & Nephew, Inc.
Investigators
Principal Investigator: John Noble, Jr, M.D. Center for Orthopaedics Lake Charles, LA
  More Information

Additional Information:
Publications:
Responsible Party: Smith & Nephew, Inc.
ClinicalTrials.gov Identifier: NCT01107769     History of Changes
Other Study ID Numbers: VISVAL01
Study First Received: April 9, 2010
Last Updated: November 18, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on October 16, 2014