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 is enrolling participants by invitation only.
Sponsor:
Collaborator:
Biomet, Inc.
Information provided by:
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01072019
First received: February 18, 2010
Last updated: March 31, 2011
Last verified: March 2011
  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, Knee
Other: Instrument

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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 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. ] [ Designated as safety issue: No ]

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. ] [ Designated as safety issue: No ]

Estimated Enrollment: 165
Study Start Date: March 2010
Estimated Primary Completion Date: March 2013 (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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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 TKA.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01072019

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

No publications provided

Responsible Party: Ryan M. Nunley, MD/Assistant Professor; Joint Preservation, Resurfacing and Replacement Service, Washington University Orthopedics
ClinicalTrials.gov Identifier: NCT01072019     History of Changes
Other Study ID Numbers: 10-0018, Ortho.CR.K018.10
Study First Received: February 18, 2010
Last Updated: March 31, 2011
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 17, 2014