Osteoarthritis Clinical Trial
Official title:
Use of the LRU Pillow in the Acute Setting Following Total Knee Arthroplasty
The Null Hypothesis is that there is no significant change in range of motion (ROM), pain, or function for a group of patients following total knee arthroplasty (TKA) who use the LRU pillow as compared to a control group of total knee arthroplasty patients who do not use the pillow.
1. Study design will be a Pretest-Posttest Control Group Design . Enrollment would be
random assignment of 20 patients to a control group vs 20 patients to a treatment group
for patients with the diagnosis of osteoarthritis (OA) of the knee admitted for primary
total knee arthroplasty. For specifics of patient assignment, please see below under
Recruitment Procedures.
2. Unpaired t-Tests will be used to determine differences between mean scores for the
dependent variables (pain, range of motion, functional mobility). Analysis of
Covariance will be run to quantify the effect of the co-variates of age, gender, body
mass index (BMI), and contralateral previous TKA. Confidence Intervals will be set at
95%.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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