Osteoarthritis of the Knee
Conditions
Keywords
total joint replacement, knee
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.
Interventions
PROCEDURETotal 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
PROCEDURETotal 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
Sponsors
Foundation for Southwest Orthopedic Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| alignment accuracy | 3 weeks post-op |
Countries
United States
Outcome results
None listed