NCT01814033

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Newton-Wellesley Hospital · Academic / Other
• Sex: All
• Age: 30 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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

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%.

Conditions

• Osteoarthritis

Interventions

Type	Name	Description
OTHER	Experimental: LRU Pillow	Foam wedge with a trough for positioning of the lower leg in an elevated position.
OTHER	Control Group	Standard bed pillows placed under the lower leg to facilitate elevation

Timeline

• Start date: 2015-11-01
• Primary completion: 2016-02-01
• Completion: 2016-03-01
• First posted: 2013-03-19
• Last updated: 2015-10-09

Locations

1 site across 1 country: United States