Stability Plus - Outcomes From Extended Continuum of Care | NCT00756483

Studies
Stability Plus - Outcomes From Extended Continuum of Care

NCT00756483

Sponsor

Stability Plus, LLC

Status

Unknown status

Last Update Posted

Sep 22, 2008Estimated

Enrollment

200Estimated

Phase

Not provided

Conditions

Arthroplasty

Interventions

Not provided

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

Sep 2008

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

Oct 2008

Primary Completion Date

Mar 2009Estimated

Completion Date

Oct 2009Estimated

First Submitted Date

Sep 18, 2008

First Submission Date that Met QC Criteria

Sep 19, 2008

First Posted Date

Sep 22, 2008Estimated

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

Sep 19, 2008

Last Update Posted Date

Sep 22, 2008Estimated

Name	Class
University of Missouri-Columbia	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Basic Protocol

Identify participant(s)
Request patient participation/Acquire Consent
Register patient at www.stabilityplus.net through the LOGIN tab
- Patient ID (Name/Initials/SSN or any combination thereof)
- Gender
- Age
- Surgical Procedure
- Date of Surgery
- Select Basic Exercise Program that corresponds with Surgical Procedure
Perform Initial Assessment using Basic Exercises for the Surgical Procedure
Enter Assessment Data at www.stabilityplus.net (through the LOGIN tab/Portal)
Within portal, modify Basic Exercise Program to create customized Stability Plus prescription for the patient
Monitor patient progress through Stability Plus portal.

Detailed Description

Not provided

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
M, 1		Male patients that have undergone total knee replacement
F, 1		Female patients that have undergone total knee replacement
M, 2		Male patients that have undergone total hip replacement
F, 2		Female patients that have undergone total hip replacement

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pre- and post- study strength assessment tests for joint specific exercises		3 months, 6 months and 12 months

Secondary Outcomes

Measure	Description	Time Frame
Reduced recovery time versus current norm		3 months, 6 months and 12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Undergone total joint replacement
Must be able to complete pre-operative strength assessment
Must be able to exercise using specified resistive bands

Exclusion Criteria:

Non-ambulatory patients

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients that have undergone total joint replacement - hip or knee

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ann M Juengermann	Contact			JuengermannA@health.missouri.edu
Linda C Landry	Contact			LandryL@health.missouri.edu

Overall Officials

Name	Affiliation	Role
James T Yost	Stability Plus, LLC	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Missouri Hospital		Columbia	Missouri	65212	United States