search
Back to results

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

Primary Purpose

Osteoarthritis

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Experimental: LRU Pillow
Control Group
Sponsored by
Newton-Wellesley Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring LRU, Total Knee Arthroplasty, Total Knee Replacement, Acute Rehabilitation Total Knee, Total Knee Range of Motion, Total Knee Acute care Outcomes

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Newton Wellesley Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

LRU Pillow

Control Group

Arm Description

Experimental: LRU Pillow

Other: Control Group

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 15, 2013
Last Updated
October 8, 2015
Sponsor
Newton-Wellesley Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT01814033
Brief Title
Use of the LRU Pillow in the Acute Setting Following Total Knee Arthroplasty
Acronym
LRU
Official Title
Use of the LRU Pillow in the Acute Setting Following Total Knee Arthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Unknown status
Study Start Date
November 2015 (undefined)
Primary Completion Date
February 2016 (Anticipated)
Study Completion Date
March 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Newton-Wellesley Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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
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%.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
LRU, Total Knee Arthroplasty, Total Knee Replacement, Acute Rehabilitation Total Knee, Total Knee Range of Motion, Total Knee Acute care Outcomes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LRU Pillow
Arm Type
Experimental
Arm Description
Experimental: LRU Pillow
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Other: Control Group
Intervention Type
Other
Intervention Name(s)
Experimental: LRU Pillow
Intervention Description
Foam wedge with a trough for positioning of the lower leg in an elevated position.
Intervention Type
Other
Intervention Name(s)
Control Group
Intervention Description
Standard bed pillows placed under the lower leg to facilitate elevation
Primary Outcome Measure Information:
Title
Range of Motion
Description
Knee ROM measured both actively and passively with a standard long arm goniometer twice daily for both groups.
Time Frame
3 Days
Secondary Outcome Measure Information:
Title
Pain
Description
Pain will be assessed using a visual analogue scale twice daily both at rest and with activity (exercise).
Time Frame
3 Days
Other Pre-specified Outcome Measures:
Title
Function
Description
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. )
Time Frame
3 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Theresa J Gustus, PT, DPT, MS
Organizational Affiliation
Newton-Wellesley Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Newton Wellesley Hospital
City
Newton
State/Province
Massachusetts
ZIP/Postal Code
02462
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hope M Violette, BS
Phone
617-243-6493
Email
hviolette1@partners.org
First Name & Middle Initial & Last Name & Degree
Theresa J Gustus, PT, MS, DPT
Phone
617-243-6885
Email
tgustus@partners.org
First Name & Middle Initial & Last Name & Degree
Theresa J Gustus, PT, DPT, MS
First Name & Middle Initial & Last Name & Degree
David A Nicoloro, PT, MS

12. IPD Sharing Statement

Citations:
PubMed Identifier
23451469
Citation
Khanasuk Y, Ngarmukos S. Contemporary pain management in total knee arthroplasty. J Med Assoc Thai. 2012 Oct;95 Suppl 10:S238-44.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs