Back to resultsA Randomized Prospective Trial of Total Knee Arthroplasty Options Comparing Standard Knee Cutting Guides and MRI Generated Patient Specific Custom Cutting Guides (Cutting Block)
Primary Purpose
Osteoarthritis of the Knee
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Instrument
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis of the Knee
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)
Sites / Locations
- Washington University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Standard knee cutting guides
MRI generated patient specific custom cutting guides
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Patient dissatisfaction following primary total knee replacement.
Secondary Outcome Measures
Postoperative recovery time following primary total knee replacement.
Full Information
NCT ID
NCT01072019
First Posted
February 18, 2010
Last Updated
June 25, 2018
Sponsor
Washington University School of Medicine
Collaborators
Zimmer Biomet
1. Study Identification
Unique Protocol Identification Number
NCT01072019
Brief Title
A Randomized Prospective Trial of Total Knee Arthroplasty Options Comparing Standard Knee Cutting Guides and MRI Generated Patient Specific Custom Cutting Guides
Acronym
Cutting Block
Official Title
Comparative Clinical Study of the Vanguard® Knee System Using Signature™ Custom Guides & Conventional Techniques
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
Collaborators
Zimmer Biomet
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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:
Standard knee cutting guides;
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis of the Knee
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard knee cutting guides
Arm Type
Active Comparator
Arm Description
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.
Arm Title
MRI generated patient specific custom cutting guides
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Instrument
Other Intervention Name(s)
Vanguard® Knee System, Signature™ Custom Guides
Intervention Description
Randomization to instrumentation to be used for primary total knee replacement; either standard knee cutting guides or MRI generated patient specific custom cutting guides.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ryan M Nunley, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
12. IPD Sharing Statement
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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
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