Use of the LRU Pillow in the Acute Setting Following Total Knee Arthroplasty

Study Overview
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Brief Summary
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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.

Detailed Description
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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. 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%.

Official Title
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Use of the LRU Pillow in the Acute Setting Following Total Knee Arthroplasty

Conditions
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Osteoarthritis

Intervention / Treatment
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* Other: Experimental: LRU Pillow
* Other: Control Group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primary total knee arthroplasty patients with primary diagnosis of osteoarthritis. Exclusion criteria: bilateral total knee arthroplasties revision total knee arthroplasties unexpected decline in medical or mental status Subjects will range from 30 years of age to 80 years of age primary diagnosis of rheumatoid arthritis

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LRU Pillow<br>Experimental: LRU Pillow | Other: Experimental: LRU Pillow<br>* Foam wedge with a trough for positioning of the lower leg in an elevated position.<br>|
| Active Comparator: Control Group<br>Other: Control Group | Other: Control Group<br>* Standard bed pillows placed under the lower leg to facilitate elevation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Range of Motion | Knee ROM measured both actively and passively with a standard long arm goniometer twice daily for both groups. | 3 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | Pain will be assessed using a visual analogue scale twice daily both at rest and with activity (exercise). | 3 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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LRU, Total Knee Arthroplasty, Total Knee Replacement, Acute Rehabilitation Total Knee, Total Knee Range of Motion, Total Knee Acute care Outcomes