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A Randomized Prospective Trial of Total Knee Arthroplasty Options Comparing Standard Knee Cutting Guides and MRI Generated Patient Specific Custom Cutting Guides (Cutting Block)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01072019
First Posted: February 19, 2010
Last Update Posted: September 3, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Zimmer Biomet
Information provided by (Responsible Party):
Ryan Nunley, Washington University School of Medicine
  Purpose

The purpose of this study is to determine the surgical and clinical outcomes of patients receiving total knee replacement with the same implant using two different types of cutting guides during surgery:

  1. Standard knee cutting guides;
  2. MRI generated patient specific custom cutting guides.

Both types of cutting guides used in this study are registered with the U.S. Food and Drug Administration (FDA) and are routinely used for knee replacement surgery. However, it is unknown if one type of cutting guide has risks or benefits over the other.


Condition Intervention
Osteoarthritis of the Knee. Other: Instrument

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparative Clinical Study of the Vanguard® Knee System Using Signature™ Custom Guides & Conventional Techniques

Resource links provided by NLM:


Further study details as provided by Ryan Nunley, Washington University School of Medicine:

Primary Outcome Measures:
  • Patient dissatisfaction following primary total knee replacement. [ Time Frame: Preoperatively, intraoperatively, and at four to six weeks, three months, six months, and one year postoperatively. ]

Secondary Outcome Measures:
  • Postoperative recovery time following primary total knee replacement. [ Time Frame: Immediate postoperative period (prior to discharge) and at four to six weeks, three months, six months, and one year postoperatively. ]

Enrollment: 25
Study Start Date: March 2010
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard knee cutting guides
Standard cutting guides use traditional instrumentation to determine knee implant positions. During surgery, a rod is placed in the leg bone and the cutting guide is attached to that rod.
Other: Instrument
Randomization to instrumentation to be used for primary total knee replacement; either standard knee cutting guides or MRI generated patient specific custom cutting guides.
Other Names:
  • Vanguard® Knee System
  • Signature™ Custom Guides
Active Comparator: MRI generated patient specific custom cutting guides
Patient specific cutting guides are custom-made for each patient based on Magnetic Resonance Imaging (MRI). Before surgery, MRI of the knee is done and used to create a cutting guide that is formed to the exact shape of the knee. The patient specific cutting guides have platforms that can be attached to the bone, so the rod does not need to be placed in the leg bone.
Other: Instrument
Randomization to instrumentation to be used for primary total knee replacement; either standard knee cutting guides or MRI generated patient specific custom cutting guides.
Other Names:
  • Vanguard® Knee System
  • Signature™ Custom Guides

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 - 75
  • Diagnosis of osteoarthritis of the knee and qualify for surgery, as indicated by one of the following:
  • Painful and disabled knee joint resulting from osteoarthritis where one or more compartments are involved;
  • Correction of varus or valgus.
  • Willing to participate and return for follow-up study visits.

Exclusion Criteria:

  • Infection
  • Sepsis
  • Osteomyelitis
  • Uncooperative patient or patient with neurologic disorders who is incapable of following directions
  • Osteoporosis
  • Metabolic disorders which may impair bone formation
  • Osteomalacia
  • Distant foci of infections which may spread to the implant site
  • Rapid joint destruction
  • Marked bone loss or bone resorption apparent on roentgenogram
  • Vascular insufficiency
  • Muscular atrophy
  • Neuromuscular disease
  • Incomplete or deficient soft tissue surrounding the knee
  • Previous osteotomy
  • Diagnosis of rheumatoid arthritis
  • Previous patella fracture or surgery
  • Previous healed tibia or femur fractures
  • Previous joint replacement surgery
  • Cannot have an MRI
  • Patients receiving single-stage bilateral total knee arthroplasty (TKA)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01072019


Locations
United States, Missouri
Washington University
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Zimmer Biomet
Investigators
Principal Investigator: Ryan M Nunley, MD Washington University School of Medicine
  More Information

Responsible Party: Ryan Nunley, Assistant Professor, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01072019     History of Changes
Other Study ID Numbers: 10-0018
Ortho.CR.K018.10 ( Other Identifier: Biomet )
First Submitted: February 18, 2010
First Posted: February 19, 2010
Last Update Posted: September 3, 2014
Last Verified: September 2014

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