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

Newton-Wellesley Hospital

Status: Unknown

Conditions: Osteoarthritis

Treatments: Other: Experimental: LRU Pillow; Other: Control Group

Study type: Interventional

Funder types: Other

Identifiers

NCT01814033

LRU1

Details and patient eligibility

About

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.

Full 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%.

Enrollment: 40 estimated patients

Sex: All

Ages: 30 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

LRU Pillow

Experimental group

Description:

Experimental: LRU Pillow

Treatment:

Other: Experimental: LRU Pillow

Control Group

Active Comparator group

Description:

Other: Control Group

Treatment:

Other: Control Group