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

Osteoarthritis Clinical Trial

— LRU  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01814033
• Other study ID #: LRU1
• Status: Not yet recruiting
• Phase: N/A
• First received: March 15, 2013
• Last updated: October 8, 2015
• Start date: November 2015
• Est. completion date: March 2016

Study information

• Verified date: October 2015
• Source: Newton-Wellesley Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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%.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: March 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Other:
• Experimental: LRU Pillow
Foam wedge with a trough for positioning of the lower leg in an elevated position.
• Control Group
Standard bed pillows placed under the lower leg to facilitate elevation

Locations

Country	Name	City	State
United States	Newton Wellesley Hospital	Newton	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Newton-Wellesley Hospital

Country where clinical trial is conducted

United States, 

References & Publications (1)

Khanasuk Y, Ngarmukos S. Contemporary pain management in total knee arthroplasty. J Med Assoc Thai. 2012 Oct;95 Suppl 10:S238-44. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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. )	3 Days	No
Primary	Range of Motion	Knee ROM measured both actively and passively with a standard long arm goniometer twice daily for both groups.	3 Days	No
Secondary	Pain	Pain will be assessed using a visual analogue scale twice daily both at rest and with activity (exercise).	3 Days	No