Use of the LRU Pillow in the Acute Setting Following Total Knee Arthroplasty
LRU
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2015
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 15, 2013
CompletedFirst Posted
Study publicly available on registry
March 19, 2013
CompletedStudy Start
First participant enrolled
November 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedOctober 9, 2015
October 1, 2015
3 months
March 15, 2013
October 8, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Range of Motion
Knee ROM measured both actively and passively with a standard long arm goniometer twice daily for both groups.
3 Days
Secondary Outcomes (1)
Pain
3 Days
Other Outcomes (1)
Function
3 Days
Study Arms (2)
LRU Pillow
EXPERIMENTALExperimental: LRU Pillow
Control Group
ACTIVE COMPARATOROther: Control Group
Interventions
Foam wedge with a trough for positioning of the lower leg in an elevated position.
Standard bed pillows placed under the lower leg to facilitate elevation
Eligibility Criteria
You may qualify if:
- Primary total knee arthroplasty patients with primary diagnosis of osteoarthritis.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Newton Wellesley Hospital
Newton, Massachusetts, 02462, United States
Related Publications (1)
Khanasuk Y, Ngarmukos S. Contemporary pain management in total knee arthroplasty. J Med Assoc Thai. 2012 Oct;95 Suppl 10:S238-44.
PMID: 23451469BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Theresa J Gustus, PT, DPT, MS
Newton-Wellesley Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Rehabilitation Services Manager
Study Record Dates
First Submitted
March 15, 2013
First Posted
March 19, 2013
Study Start
November 1, 2015
Primary Completion
February 1, 2016
Study Completion
March 1, 2016
Last Updated
October 9, 2015
Record last verified: 2015-10