A Comparative Study of Knee Systems (Bake-Off)
This study has been completed.
Sponsor:
Foundation for Southwest Orthopedic Research
Information provided by:
Foundation for Southwest Orthopedic Research
ClinicalTrials.gov Identifier:
NCT01331278
First received: April 6, 2011
Last updated: April 7, 2011
Last verified: April 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Osteoarthritis of the Knee |
Procedure: Total Knee Arthroplasty with Custom Cutting Blocks Procedure: Total Knee Arthroplasty via Computer Assisted Surgery |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Comparative Study of Knee Systems Employing Personalized Computer Generated Cutting Guides for Total Knee Arthroplasty |
Resource links provided by NLM:
Further study details as provided by Foundation for Southwest Orthopedic Research:
Primary Outcome Measures:
- mean intraoperative time [ Time Frame: measured during surgery (day 1) ] [ Designated as safety issue: No ]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 [ Time Frame: 3 weeks post-op ] [ Designated as safety issue: No ]
| Enrollment: | 60 |
| Study Start Date: | September 2009 |
| Study Completion Date: | March 2011 |
| Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Custom Cutting Blocks |
Procedure: Total Knee Arthroplasty with 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 Name: Signature Knee System
|
| Active Comparator: Computer Assisted Surgery |
Procedure: Total Knee Arthroplasty via Computer Assisted Surgery
Subjects randomized to this study group will receive TKA via computer assisted surgery and a Biomet Vanguard knee implant
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01331278
Locations
| United States, Texas | |
| The Methodist Hospital | |
| Houston, Texas, United States, 77030 | |
| Southwest Orthopedic Group, LLP | |
| Houston, Texas, United States, 77030 | |
Sponsors and Collaborators
Foundation for Southwest Orthopedic Research
More Information
No publications provided
| Responsible Party: | David R. Lionberger, MD, Southwest Orthopedic Group, LLP |
| ClinicalTrials.gov Identifier: | NCT01331278 History of Changes |
| Other Study ID Numbers: | 0509-0060 |
| Study First Received: | April 6, 2011 |
| Last Updated: | April 7, 2011 |
| Health Authority: | United States: The Methodist Hospital research Institute Institutional Review Board United States: Institutional Review Board |
Keywords provided by Foundation for Southwest Orthopedic Research:
|
total joint replacement knee |
Additional relevant MeSH terms:
|
Osteoarthritis Osteoarthritis, Knee Arthritis |
Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |
ClinicalTrials.gov processed this record on May 21, 2013