- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01331278
A Comparative Study of Knee Systems (Bake-Off)
April 7, 2011 updated by: Foundation for Southwest Orthopedic Research
A Comparative Study of Knee Systems Employing Personalized Computer Generated Cutting Guides for Total Knee Arthroplasty
The custom cutting guides personalized for each patient via pre-operative MRI will result in significantly faster intraoperative time with comparable knee alignment accuracy, cost, knee function, and patient satisfaction.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- The Methodist Hospital
-
Houston, Texas, United States, 77030
- Southwest Orthopedic Group, LLP
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- must be scheduled to undergo TKA with no bilateral TKA planned within 6 weeks of the initial surgery date
- must be 18 years of age or older
- must be capable and willing to provide informed consent
- must have flexion contracture less than 15 degrees.
- must have ligament stability no more than 2 degrees instability in varus/valgus extension stress
Exclusion Criteria:
- medical condition or personal circumstances that will prevent participation and completion of the follow-up visits at 3 weeks, 6 weeks and 3 months post-op
- currently participating in or has participated in (within 30 days prior to inclusion in this study) another clinical trial of an investigational drug, biologic, device, or procedure
- known pre-operative systemic infections, uncontrolled diabetes, or diseases or conditions that are known to interfere with the wound healing process
- Knee alignment deformities greater than 7 degrees varus or valgus
- known prior knee revisions or previous surgeries deemed to compromise the TKA incision exposure
- known medical conditions prohibiting the use of MRI or nickel allergy, sensitivity, or hardware in the region of the knee
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Custom Cutting Blocks
|
Subjects randomized to this study group will undergo TKA with patient specific custom cutting blocks generated by pre-op MRI and a Biomet Vanguard knee implant
Other Names:
|
Active Comparator: Computer Assisted Surgery
|
Subjects randomized to this study group will receive TKA via computer assisted surgery and a Biomet Vanguard knee implant
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
mean intraoperative time
Time Frame: measured during surgery (day 1)
|
Time measured in pre-defined segments from the point that the patient is wheeled into the OR until the OR is clean and ready for the next case's activities to begin.
|
measured during surgery (day 1)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
alignment accuracy
Time Frame: 3 weeks post-op
|
3 weeks post-op
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2009
Primary Completion (Actual)
August 1, 2010
Study Completion (Actual)
March 1, 2011
Study Registration Dates
First Submitted
April 6, 2011
First Submitted That Met QC Criteria
April 7, 2011
First Posted (Estimate)
April 8, 2011
Study Record Updates
Last Update Posted (Estimate)
April 8, 2011
Last Update Submitted That Met QC Criteria
April 7, 2011
Last Verified
April 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0509-0060
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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