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OpenTrials
Completed

NCT Number: NCT01072019

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

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.

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Key information

Conditions

Osteoarthritis of the Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington University

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Instrument

Other

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

Primary outcomes

  1. 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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • Zimmer Biomet

Registry information

Official study title

Comparative Clinical Study of the Vanguard® Knee System Using Signature™ Custom Guides & Conventional Techniques

Acronym: Cutting Block

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Feb 19, 2010
Registry last updated
Jun 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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