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:
Washington University School of Medicine
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
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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:
- 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.
| 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:
|
|
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:
|
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 School of Medicine |
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 June 18, 2013