Knee Osteoarthritis
Conditions
Keywords
Total Knee Replacement, Gender Specific Design
Brief summary
The purpose of this study is to compare results obtained with gender-specific and traditional knee replacement systems design among women undergoing total knee replacement surgery. Women who qualify and agree to participate will be randomly assigned to receive either a traditional or gender-specific knee replacement. During surgery, measurements of bone resection and bone-to-implant relationships will be recorded. At selected time intervals, participants will be asked to fill out questionnaires regarding pain and function, will be examined by their surgeon and routinely obtained xrays will be evaluated. In addition, a subset of participants will be randomly selected to undergo gait analysis to evaluate knee motion and muscle function.
Interventions
DEVICEZimmer LPS flex Gender Specific Implant (Total knee replacement)
Outcomes comparison between a gender specific total knee implant, a standard total knee implant by the same company, and a standard total knee implant from another company
DEVICEZimmer High Flex LPS Implant (Total knee replacement)
Outcomes comparison between a gender specific total knee implant, a standard total knee implant by the same company, and a standard total knee implant from another company
DEVICEStryker Triathlon Implant (Total knee replacement)
Outcomes comparison between a gender specific total knee implant, a standard total knee implant by the same company, and a standard total knee implant from another company
Sponsors
Stryker Orthopaedics
UConn Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* clinical diagnosis of end-stage degenerative joint disease of the knee * must be deemed appropriate for total knee replacement surgery
Exclusion criteria
* severe flexion deformity of the knee * greater than 20deg varus or valgus malalignment * osteomyelitis, septicemia, prior infection of the knee joint * presence of infections or highly communicable diseases * significant neurological or musculoskeletal disorders that affect gait or ability to bear weight on lower extremity * metastatic disease * congenital, developmental, bone disease or previous knee surgery that may interfere with the total knee prosthesis survival or success * previous total knee replacement in affected knee * arthrodesis of the affected knee
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evidence of improved pain relief and function | Pre-op, 4 weeks, 4 months, 1 year, 2 years |
Secondary
| Measure | Time frame |
|---|---|
| Evidence of improved patellofemoral biomechanics | Pre-op, 4 months, 1 year |
Outcome results
None listed