Clinical trial NCT01084772: Visionaire™ Versus Standard Instrumentation Safety and Efficacy in Total Knee Arthroplasty (TKA)
Official title: A Multicenter, Randomized, Clinical Outcome of VISIONAIRE™ Patient Matched Technology vs. Standard Surgical Instrumentation in Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Degenerative Arthritis of Knee
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
First posted: 2010-03-10
Enrollment: 134
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Total Score
timeFrame: 2 years postoperatively
measure: Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire
timeFrame: 2 years postoperatively
Secondary outcomes:
measure: Evaluation of Mechanical Alignment Assessed as Either Neutral or Varus/Valgus 3 Months Postoperatively Using a Full Leg X-ray
timeFrame: 3 months postoperative
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS) Preoperatively and Postoperatively
timeFrame: Baseline (preoperative), 3 months, 1 year, and 2 years postoperatively
measure: Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
timeFrame: 1 year postoperatively
measure: Radiographic Outcomes to Assess Evidence of Loosening at 1 Year Postoperatively
timeFrame: 1 year postoperatively
measure: Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
timeFrame: 2 years postoperatively
measure: Radiographic Outcomes to Assess Evidence of Loosening at 2 Years Postoperatively
timeFrame: 2 years postoperatively
measure: Evaluation of Health Economic Criteria - Surgical Time Details
timeFrame: During and immediately following surgery
measure: Evaluation of Health Economic Criteria - Blood Loss
timeFrame: During and immediately following surgery
measure: Evaluation of Health Economic Criteria - Incision Length
timeFrame: During and immediately following surgery
measure: Evaluation of Health Economic Criteria - Instrument Tray Use
timeFrame: During and immediately following surgery
measure: Evaluation of Health Economic Surgical Criteria
timeFrame: During and immediately following surgery
Other outcomes:
Locations:
city: Park Ridge
country: United States
facility: Orthopaedic Surgery Specialist, Ltd.
state: Illinois
city: Springfield
country: United States
facility: Southern Illinois University School of Medicine
state: Illinois
city: Saint Louis
country: United States
facility: Town & Country Orthopedics
state: Missouri
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Winston-Salem
country: United States
facility: Wake Forest University School of Medicine
state: North Carolina
city: Eugene
country: United States
facility: Slocum Research & Education Foundation
state: Oregon
city: Windsor
country: Australia
facility: Malabar Orthopaedic Clinic
state: Victoria
Study officials:
affiliation: Smith & Nephew, Inc.
name: Beate Hanson, MD, PhD
role: STUDY_DIRECTOR
References: