Use of the LRU Pillow in the Acute Setting Following Tota... | NCT01814033

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

NCT01814033

Sponsor

Newton-Wellesley Hospital

Status

Unknown status

Last Update Posted

Oct 9, 2015Estimated

Enrollment

40Estimated

Phase

Not Applicable

Conditions

Osteoarthritis

Interventions

Experimental: LRU Pillow
Control Group

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2015

Primary Completion Date

Feb 2016Estimated

Completion Date

Mar 2016Estimated

First Submitted Date

Mar 15, 2013

First Submission Date that Met QC Criteria

Mar 18, 2013

First Posted Date

Mar 19, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 8, 2015

Last Update Posted Date

Oct 9, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Theresa J. Gustus, Rehabilitation Services Manager, Newton-Wellesley HospitalPrincipal Investigator

Lead Sponsor

Newton-Wellesley HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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%.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
LRU Pillow	Experimental	Experimental: LRU Pillow	Other: Experimental: LRU Pillow
Control Group	Active Comparator	Other: Control Group	Other: Control Group

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Experimental: LRU Pillow	Other	Foam wedge with a trough for positioning of the lower leg in an elevated position.	LRU Pillow

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Pain	Pain will be assessed using a visual analogue scale twice daily both at rest and with activity (exercise).	3 Days

Other Outcomes

Measure	Description	Time Frame
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

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Theresa J Gustus, PT, DPT, MS	Newton-Wellesley Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Newton Wellesley Hospital		Newton	Massachusetts	02462	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23451469	Background	Khanasuk Y, Ngarmukos S. Contemporary pain management in total knee arthroplasty. J Med Assoc Thai. 2012 Oct;95 Suppl 10:S238-44.

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

ID	Term
D015340	Epidemiologic Research Design
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D012107	Research Design