Visionaire™ Versus Standard Instrumentation Safety and Efficacy in Total Knee Arthroplasty (TKA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Smith & Nephew, Inc.
Sponsor:
Information provided by (Responsible Party):
Smith & Nephew, Inc.
ClinicalTrials.gov Identifier:
NCT01084772
First received: February 19, 2010
Last updated: March 31, 2014
Last verified: March 2014

February 19, 2010
March 31, 2014
April 2010
December 2014   (final data collection date for primary outcome measure)
KSS Knee Society Clinical rating system complete analysis at 2 years following surgery [ Time Frame: Evaluation will be performed at preoperative, operative/discharge, 3 months, 1 year and 2 years after TKA. ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01084772 on ClinicalTrials.gov Archive Site
The secondary objective is to compare the safety, quality of life, and economic outcomes of TKA when these two techniques are utilized. [ Time Frame: Analysis will be performed at preoperative, operative/discharge, 3 months, 1 year and 2 years after TKA. ] [ Designated as safety issue: Yes ]
Objective will be assessed by analysis of mechanical alignment preoperatively and postoperatively using a full leg x-ray; Knee injury and Osteoarthritis Outcome Score (KOOS) preoperatively and postoperatively; and Serial radiographic evaluation postoperatively to assess any evidence of loosening as indicated primarily by radiolucencies > 2mm; lack of evidence of surface wear or particulate debris generation as indicated by early osteolysis, implant migration, or other clinical or radiographic abnormalities; and analysis of Health Economic Criteria
Same as current
Not Provided
Not Provided
 
Visionaire™ Versus Standard Instrumentation Safety and Efficacy in Total Knee Arthroplasty (TKA)
A Multicenter, Randomized, Clinical Outcome of VISIONAIRE™ Patient Matched Technology vs. Standard Surgical Instrumentation in Total Knee Arthroplasty

The objective of this study is to assess outcomes following TKA, utilizing two surgical techniques. Patients will be randomized to one of two arms: TKA with standard instrumentation and TKA with VISIONAIRE™ patient-matched cutting blocks. Data will be collected at preoperative, operative/discharge, 3 months, 1 year and 2 years after TKA. The secondary objective of this study is to compare the safety, quality of life, and economic outcomes of TKA when these two techniques are utilized. This study does not involve treatment or investigational products, as all components are FDA cleared and are commercially available.

This is a prospective study comparing VISIONAIRE™ to standard TKA instrumentation. The objective of this study is to evaluate the safety and efficacy of TKA using VISIONAIRE™ when compared with standard instrumentation, including device survival, improvement in function and implant alignment after TKA. This study will also document any device-related, surgical complications and/or adverse radiographic observations.

In contrast with the control group clinical outcomes following TKA completed with VISIONAIRE™ have yet to be assessed. The current investigation will determine if there is any difference in TKA outcomes when VISIONAIRE™ patient matched technology is utilized versus standard instrumentation. 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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Degenerative Arthritis of Knee
  • Other: Total Knee Arthroplasty
    TKA will be performed with VISIONAIRE instrumentation or standard instrumentation, depending on randomization assignment.
  • Other: Total Knee Arthroplasty
    TKA will be performed with VISIONAIRE patient matched instrumentation or standard instrumentation, depending on randomization assignment.
  • VISIONAIRE Instrumentation
    TKA with VISIONAIRE instrumentation
    Intervention: Other: Total Knee Arthroplasty
  • Standard Instrumentation
    TKA with standard instrumentation
    Intervention: Other: Total Knee Arthroplasty
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
196
June 2015
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

Patients must meet all of the inclusion criteria.

  1. Patient diagnosed with degenerative arthritis of the knee requiring a unilateral primary TKA.
  2. Patient is of legal age to consent and is skeletally mature.
  3. Patient is willing to sign and date an ethics-approved consent form.
  4. Patient is willing to be available for two-year follow-up postoperatively

Exclusion Criteria:

Patients must not meet any of the exclusion criteria.

  1. Patient is known to have poor bone stock making a TKA unjustifiable.
  2. Patient is immuno-suppressed.
  3. Patient has physical, emotional or neurological conditions that would compromise the patient's compliance with postoperative rehabilitation and follow-up.
  4. Patient is pregnant or may become pregnant during the course of the study.
  5. Patient has a history of prior ipsilateral major knee surgery (e.g. arthroplasty, high tibial osteotomy, or tibial plateau fracture). Minor prior procedures such as ACL repair, meniscectomy, or arthroscopy are not excluded.
  6. Patient has active, localized or systemic infection.
  7. Patient is severely overweight (BMI >40).
  8. Patient is a prisoner.
  9. Subject has a significant MRI (magnetic resonance imaging) exclusion or contraindication.
  10. Patient has had a total joint arthroplasty of the contralateral limb in the last 12 months.
Both
Not Provided
No
Contact: Laura Yacoubian, MS 1-800-821-5700 ext 3039 laura.yacoubian@smith-nephew.com
Contact: Cathy Newbill, BS,CCRA 1-800-821-5700 ext 6422 cathy.newbill@smith-nephew.com
United States,   Australia
 
NCT01084772
VISSTD01
No
Smith & Nephew, Inc.
Smith & Nephew, Inc.
Not Provided
Not Provided
Smith & Nephew, Inc.
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP