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

NCT ID: NCT01084772

Last Updated: 2020-04-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 134 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-21
• Study Completion Date: 2015-09-30

Brief Summary

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.

Detailed Description

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.

Conditions

Degenerative Arthritis of Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

VISIONAIRE Instrumentation

TKA with VISIONAIRE instrumentation

Group Type: OTHER

VISIONAIRE Total Knee Arthroplasty

Intervention Type: OTHER

TKA will be performed with VISIONAIRE instrumentation, depending on randomization assignment.

Standard Instrumentation

TKA with standard instrumentation

Group Type: OTHER

Standard Total Knee Arthroplasty

Intervention Type: OTHER

TKA will be performed with standard instrumentation, depending on randomization assignment.

Interventions

VISIONAIRE Total Knee Arthroplasty

TKA will be performed with VISIONAIRE instrumentation, depending on randomization assignment.

Intervention Type: OTHER

Standard Total Knee Arthroplasty

TKA will be performed with standard instrumentation, depending on randomization assignment.

Intervention Type: OTHER

Eligibility Criteria

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

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Smith & Nephew, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Beate Hanson, MD, PhD

Role: STUDY_DIRECTOR

Smith & Nephew, Inc.

Locations

Orthopaedic Surgery Specialist, Ltd.

Park Ridge, Illinois, United States

Southern Illinois University School of Medicine

Springfield, Illinois, United States

Town & Country Orthopedics

St Louis, Missouri, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

Wake Forest University School of Medicine

Winston-Salem, North Carolina, United States

Slocum Research & Education Foundation

Eugene, Oregon, United States

Malabar Orthopaedic Clinic

Windsor, Victoria, Australia

Countries

United States; Australia

Other Identifiers

VISSTD01

Identifier Type: -

Identifier Source: org_study_id