A Comparative Study of Knee Systems
Bake-Off
1 other identifier
interventional
60
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Sep 2009
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedFirst Submitted
Initial submission to the registry
April 6, 2011
CompletedFirst Posted
Study publicly available on registry
April 8, 2011
CompletedApril 8, 2011
April 1, 2011
11 months
April 6, 2011
April 7, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
measured during surgery (day 1)
Secondary Outcomes (1)
alignment accuracy
3 weeks post-op
Study Arms (2)
Custom Cutting Blocks
ACTIVE COMPARATORComputer Assisted Surgery
ACTIVE COMPARATORInterventions
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
Subjects randomized to this study group will receive TKA via computer assisted surgery and a Biomet Vanguard knee implant
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Southwest Orthopedic Group, LLP
Houston, Texas, 77030, United States
The Methodist Hospital
Houston, Texas, 77030, United States
Related Publications (1)
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.
PMID: 24810539DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 6, 2011
First Posted
April 8, 2011
Study Start
September 1, 2009
Primary Completion
August 1, 2010
Study Completion
March 1, 2011
Last Updated
April 8, 2011
Record last verified: 2011-04