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

NCT ID: NCT01072019

Last Updated: 2018-06-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2014-05-31

Brief Summary

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.

Conditions

Osteoarthritis of the Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Instrument

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Instrument

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

Vanguard® Knee System; Signature™ Custom Guides

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zimmer Biomet

INDUSTRY

Sponsor Role: collaborator

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ryan M Nunley, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Washington University

St Louis, Missouri, United States

Countries

United States

Other Identifiers

Ortho.CR.K018.10

Identifier Type: OTHER

Identifier Source: secondary_id

10-0018

Identifier Type: -

Identifier Source: org_study_id