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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01814033
Acronym
LRU
Enrollment
40
Registered
2013-03-19
Start date
2015-11-30
Completion date
2016-03-31
Last updated
2015-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis

Keywords

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

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%.

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

Sponsors

Newton-Wellesley Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Range of Motion3 DaysKnee ROM measured both actively and passively with a standard long arm goniometer twice daily for both groups.

Secondary

MeasureTime frameDescription
Pain3 DaysPain will be assessed using a visual analogue scale twice daily both at rest and with activity (exercise).

Other

MeasureTime frameDescription
Function3 DaysFunctional 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. )

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026