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

October 8, 2015 updated by: Theresa J. Gustus, Newton-Wellesley Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Newton, Massachusetts, United States, 02462
        • Newton Wellesley Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Theresa J Gustus, PT, DPT, MS
        • Sub-Investigator:
          • David A Nicoloro, PT, MS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: LRU Pillow
Experimental: LRU Pillow
Other: Experimental: LRU Pillow
Foam wedge with a trough for positioning of the lower leg in an elevated position.
ACTIVE_COMPARATOR: Control Group
Other: Control Group
Other: Control Group
Standard bed pillows placed under the lower leg to facilitate elevation

What is the study measuring?

Primary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Function
Time Frame: 3 Days
Functional parameters of bed mobility, transfers, ambulation, gait, and stair climbing will be assessed daily using standard measures used in physical therapy assessment( dependent, moderate assist of one or two, minimal assist of one or two, hands on supervision, stand by supervision, or independence. )
3 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Newton-Wellesley Hospital

Investigators

  • Principal Investigator: Theresa J Gustus, PT, DPT, MS, Newton-Wellesley Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (ANTICIPATED)

February 1, 2016

Study Completion (ANTICIPATED)

March 1, 2016

Study Registration Dates

First Submitted

March 15, 2013

First Submitted That Met QC Criteria

March 18, 2013

First Posted (ESTIMATE)

March 19, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

October 9, 2015

Last Update Submitted That Met QC Criteria

October 8, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LRU1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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