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

NCT01084772 | Terminated Results

• 1 other identifier: VISSTD01
• Study Type: interventional
• Target: 134
• Locations: 2 countries
• Sites: 7

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.

Conditions

Degenerative Arthritis of Knee

Outcome Measures

Primary Outcomes (2)

• Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Total Score

  The KSS was used to rate both the prosthesis function and the patient's functional abilities after TKA. The KSS Total Score (0-100 points) included a combined evaluation of joint motion (0-25 points), instability (0-25 points), alignment (0-25 points), and symptoms (0-25 points). A higher score indicated a better outcome for subjects.

  2 years postoperatively

• Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire

  The KSS was used to rate both the prosthesis function and the patient's functional abilities after TKA. The KSS clinical evaluation included a questionnaire completed by the investigators to assess for pain, stability, flexion contracture, extension lag, and alignment and evaluated based on number of subjects experiencing any of these issues at the 2-year postoperative visit.

  2 years postoperatively

Secondary Outcomes (11)

• Evaluation of Mechanical Alignment Assessed as Either Neutral or Varus/Valgus 3 Months Postoperatively Using a Full Leg X-ray

  3 months postoperative

• Knee Injury and Osteoarthritis Outcome Score (KOOS) Preoperatively and Postoperatively

  Baseline (preoperative), 3 months, 1 year, and 2 years postoperatively

• Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively

  1 year postoperatively

• Radiographic Outcomes to Assess Evidence of Loosening at 1 Year Postoperatively

  1 year postoperatively

• Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively

  2 years postoperatively

Study Arms (2)

VISIONAIRE Instrumentation

OTHER

TKA with VISIONAIRE instrumentation

Other: VISIONAIRE Total Knee Arthroplasty

Standard Instrumentation

OTHER

TKA with standard instrumentation

Other: Standard Total Knee Arthroplasty

Interventions

VISIONAIRE Total Knee Arthroplasty OTHER

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

VISIONAIRE Instrumentation

Standard Total Knee Arthroplasty OTHER

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

Standard Instrumentation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patient is known to have poor bone stock making a TKA unjustifiable.
• Patient is immuno-suppressed.
• Patient has physical, emotional or neurological conditions that would compromise the patient's compliance with postoperative rehabilitation and follow-up.
• Patient is pregnant or may become pregnant during the course of the study.
• 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.
• Patient has active, localized or systemic infection.
• Patient is severely overweight (BMI \>40).
• Patient is a prisoner.
• Patient has had a total joint arthroplasty of the contralateral limb in the last 12 months.

Sponsors & Collaborators

• Smith & Nephew, Inc.: lead

Study Sites (7)

Orthopaedic Surgery Specialist, Ltd.

Park Ridge, Illinois, 60068, United States

Location

Southern Illinois University School of Medicine

Springfield, Illinois, 62794-9679, United States

Location

Town & Country Orthopedics

St Louis, Missouri, 63131, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198-1080, United States

Location

Wake Forest University School of Medicine

Winston-Salem, North Carolina, 27157-1070, United States

Location

Slocum Research & Education Foundation

Eugene, Oregon, 97401, United States

Location

Malabar Orthopaedic Clinic

Windsor, Victoria, 3181, Australia

Location

Limitations and Caveats

The major limitation for this study was not reaching the target number of participants needed to achieve target power and statistical analyses leading to uninterpretable data.

Results Point of Contact

• Title: Stuart Pratt
• Organization: Smith & Nephew, Inc.

stuart.pratt@smith-nephew.com

+1 (901) 497-0365

Study Officials

• Beate Hanson, MD, PhD

  Smith & Nephew, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2010
• First Posted: March 10, 2010
• Study Start: June 21, 2012
• Primary Completion: April 15, 2014
• Study Completion: September 1, 2015
• Last Updated: April 3, 2020
• Results First Posted: April 3, 2020

Record last verified: 2020-03

Locations

US (6); AU (1)