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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2016-03-31

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.

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Detailed Description

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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

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Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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LRU Pillow

Experimental: LRU Pillow

Group Type EXPERIMENTAL

Experimental: LRU Pillow

Intervention Type OTHER

Foam wedge with a trough for positioning of the lower leg in an elevated position.

Control Group

Other: Control Group

Group Type ACTIVE_COMPARATOR

Control Group

Intervention Type OTHER

Standard bed pillows placed under the lower leg to facilitate elevation

Interventions

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Experimental: LRU Pillow

Foam wedge with a trough for positioning of the lower leg in an elevated position.

Intervention Type OTHER

Control Group

Standard bed pillows placed under the lower leg to facilitate elevation

Intervention Type OTHER

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

Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No