Back to resultsA Comparative Study of Knee Systems (Bake-Off)
Primary Purpose
Osteoarthritis of the Knee
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Total Knee Arthroplasty with Custom Cutting Blocks
Total Knee Arthroplasty via Computer Assisted Surgery
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis of the Knee focused on measuring total joint replacement, knee
Eligibility Criteria
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
Sites / Locations
- Southwest Orthopedic Group, LLP
- The Methodist Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Custom Cutting Blocks
Computer Assisted Surgery
Arm Description
Outcomes
Primary Outcome Measures
mean intraoperative time
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.
Secondary Outcome Measures
alignment accuracy
Full Information
NCT ID
NCT01331278
First Posted
April 6, 2011
Last Updated
April 7, 2011
Sponsor
Foundation for Southwest Orthopedic Research
1. Study Identification
Unique Protocol Identification Number
NCT01331278
Brief Title
A Comparative Study of Knee Systems
Acronym
Bake-Off
Official Title
A Comparative Study of Knee Systems Employing Personalized Computer Generated Cutting Guides for Total Knee Arthroplasty
Study Type
Interventional
2. Study Status
Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
March 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Foundation for Southwest Orthopedic Research
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis of the Knee
Keywords
total joint replacement, knee
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Custom Cutting Blocks
Arm Type
Active Comparator
Arm Title
Computer Assisted Surgery
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Total Knee Arthroplasty with Custom Cutting Blocks
Other Intervention Name(s)
Signature Knee System
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Total Knee Arthroplasty via Computer Assisted Surgery
Intervention Description
Subjects randomized to this study group will receive TKA via computer assisted surgery and a Biomet Vanguard knee implant
Primary Outcome Measure Information:
Title
mean intraoperative time
Description
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.
Time Frame
measured during surgery (day 1)
Secondary Outcome Measure Information:
Title
alignment accuracy
Time Frame
3 weeks post-op
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Southwest Orthopedic Group, LLP
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
The Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
24810539
Citation
Lionberger DR, Crocker CL, Chen V. Patient specific instrumentation. J Arthroplasty. 2014 Sep;29(9):1699-704. doi: 10.1016/j.arth.2014.03.019. Epub 2014 Mar 28.
Results Reference
derived
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A Comparative Study of Knee Systems
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