CClinicalTrials.gg
Status unknownNCT01814033LRUUpdated Oct 9, 2015

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

An interventional study of Experimental: LRU Pillow and Control Group in Osteoarthritis, sponsored by Newton-Wellesley Hospital. Status unknown at 1 site in United States. Open to participants aged 30 Years to 80 Years. Per ClinicalTrials.gov, last updated 2015-10-09.

Sponsored by Newton-Wellesley Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2015), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
30 Years to 80 Years
Sex
All
01

Study 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.

Read the 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%.
02

Conditions studied

  • Osteoarthritis

Browse trials for

Keywords

  • LRU
  • Total Knee Arthroplasty
  • Total Knee Replacement
  • Acute Rehabilitation Total Knee
  • Total Knee Range of Motion
  • Total Knee Acute care Outcomes
03

In context

Osteoarthritis

4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.

This study's planned enrollment of 40 is below the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

Newton-Wellesley Hospital is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Primary total knee arthroplasty patients with primary diagnosis of osteoarthritis.

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    LRU Pillow

    Experimental: LRU Pillow

    Other: Experimental: LRU Pillow

  • Active comparator
    Control Group

    Other: Control Group

    Other: Control Group

Interventions

  • OtherExperimental: LRU Pillow

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

  • OtherControl Group

    Standard bed pillows placed under the lower leg to facilitate elevation

06

What researchers measure

Primary outcomes

  1. Range of Motion

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

    Time frame: 3 Days

Secondary outcomes

  1. Pain

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

    Time frame: 3 Days

Other outcomes

  1. Function

    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

07

Study locations

1 site
  • Newton Wellesley Hospital
    Newton, Massachusetts 02462, United States
    • Hope M Violette, BS · Contact · hviolette1@partners.org · 617-243-6493
    • Theresa J Gustus, PT, MS, DPT · Contact · tgustus@partners.org · 617-243-6885
    • Theresa J Gustus, PT, DPT, MS · Principal investigator
    • David A Nicoloro, PT, MS · Sub investigator
08

References and documents

Publications

  • Khanasuk Y, Ngarmukos S. Contemporary pain management in total knee arthroplasty. J Med Assoc Thai. 2012 Oct;95 Suppl 10:S238-44. PubMed 23451469 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 9, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01814033
Lead sponsor
Newton-Wellesley Hospital
Responsible party
Theresa J. Gustus (Rehabilitation Services Manager, Newton-Wellesley Hospital) — Principal investigator
First posted
Mar 19, 2013
Start date
Nov 2015
Primary completion
Feb 2016 (estimated)
Completion
Mar 2016 (estimated)
Last update
Oct 9, 2015

Study contacts

Theresa J Gustus, PT, DPT, MS
principal investigator · Newton-Wellesley Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion