A Comparative Study of Knee Systems
Completed · Phase 4
Conditions studied: Osteoarthritis of the Knee
In brief
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.
Key facts
- Study ID
- NCT01331278
- Run by
- Foundation for Southwest Orthopedic Research
- People needed
- 60
- Starts
- 2009-09-01
- Expected to finish
- 2011-03-01
- Last updated by the study team
- 2011-04-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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
- 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
Where it is running
- Southwest Orthopedic Group, LLP — Houston, Texas, United States
- The Methodist Hospital — Houston, Texas, United States
Full record on ClinicalTrials.gov
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