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

Not Applicable

• Conditions: Osteoarthritis
• Interventions: Other: Control Group

• Registration Number: NCT01814033
• Lead Sponsor: Newton-Wellesley Hospital

Brief 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%.

Study Timeline

• Study First Submitted: 2013-03-15
• Study First Submitted QC: 2013-03-18
• Study First Posted: 2013-03-19
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-08
• Last Update Posted: 2015-10-09
• Study Start: 2015-11
• Primary Completion: 2016-02
• Study Completion: 2016-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Control Group	Other: Control Group

Primary Outcome Measures

Name	Time	Method
Range of Motion	3 Days	Knee ROM measured both actively and passively with a standard long arm goniometer twice daily for both groups.

Secondary Outcome Measures

Name	Time	Method
Pain	3 Days	Pain will be assessed using a visual analogue scale twice daily both at rest and with activity (exercise).

Trial Locations

Locations (1)

Newton Wellesley Hospital; 🇺🇸 Newton, Massachusetts, United States