A Comparative Study of Knee Systems
Phase 4
Completed
- Conditions
- Osteoarthritis of the Knee
- Registration Number
- NCT01331278
- Lead Sponsor
- Foundation for Southwest Orthopedic Research
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method mean intraoperative time 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.
- Secondary Outcome Measures
Name Time Method alignment accuracy 3 weeks post-op
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms improve knee alignment accuracy using personalized computer generated cutting guides in total knee arthroplasty for osteoarthritis of the knee?
How does personalized computer generated cutting guide compare to standard-of-care techniques in total knee arthroplasty for osteoarthritis of the knee in terms of intraoperative time and patient satisfaction?
What biomarkers are used to predict the effectiveness of personalized computer generated cutting guides in total knee arthroplasty for patients with osteoarthritis of the knee?
What are the potential adverse events associated with personalized computer generated cutting guides in total knee arthroplasty for osteoarthritis of the knee and how are they managed?
What are the related compounds or combination approaches used in total knee arthroplasty for osteoarthritis of the knee compared to personalized computer generated cutting guides in NCT01331278?
Trial Locations
- Locations (2)
Southwest Orthopedic Group, LLP
🇺🇸Houston, Texas, United States
The Methodist Hospital
🇺🇸Houston, Texas, United States
Southwest Orthopedic Group, LLP🇺🇸Houston, Texas, United States