Suspended

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

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What is being tested

Experimental: LRU Pillow

+ Control Group

Other
Who is being recruted

Arthritis+2

+ Joint Diseases

+ Musculoskeletal Diseases

From 30 to 80 Years
+6 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: November 2015
See protocol details

Summary

Principal SponsorNewton-Wellesley Hospital
Study ContactHope M Violette, BSMore contacts
Last updated: October 9, 2015
Sourced from a government-validated database.Claim as a partner

Study start date: November 1, 2015

Actual date on which the first participant was enrolled.

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. 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%.

NCT01814033
Principal SponsorNewton-Wellesley Hospital
Study ContactHope M Violette, BSMore contacts
Last updated: October 9, 2015
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

40 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 30 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesOsteoarthritis

Criteria

1 inclusion criteria required to participate
Primary total knee arthroplasty patients with primary diagnosis of osteoarthritis
5 exclusion criteria prevent from participating
Subjects will range from 30 years of age to 80 years of age
bilateral total knee arthroplasties
primary diagnosis of rheumatoid arthritis
revision total knee arthroplasties
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Experimental: LRU Pillow

Group II

Active Comparator
Other: Control Group

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Newton Wellesley Hospital

Newton, United StatesOpen Newton Wellesley Hospital in Google Maps
SuspendedOne Study Center