INTUIT Hip Fracture Outcome Study | NCT00595634

Studies
INTUIT Hip Fracture Outcome Study

NCT00595634

Sponsor

Smith & Nephew, Inc.

Status

Terminated

Last Update Posted

Apr 1, 2014Estimated

Enrollment

92Actual

Phase

Not provided

Conditions

Unstable Intertrochanteric Hip Fractures

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

Mar 2014

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Could not power primary endpoint due to lost to follow-up rate

Expanded Access Info

Start Date

Jan 2008

Primary Completion Date

Nov 2013Actual

Completion Date

Nov 2013Actual

First Submitted Date

Jan 4, 2008

First Submission Date that Met QC Criteria

Jan 4, 2008

First Posted Date

Jan 16, 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

Mar 31, 2014

Last Update Posted Date

Apr 1, 2014Estimated

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 primary objective of this study is to characterize patients' course of recovery in the year following the initial surgery for unstable intertrochanteric hip fractures treated with the InterTAN intramedullary hip screw device. This will be done by collecting patient outcome measures of health related quality of life and functional status including return to normal gait. Secondary objectives are to document any adverse events associated with the procedure, and to analyze differences in recovery due to differences in age, gender, co-morbidities, nutrition, residence and ambulation status, and use of mobility aids.

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

92Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mobility function as defined by the Timed Up & Go (TUG) frequency.		Baseline, Post-Operatively at 2 Weeks, 6 Weeks, 3 Months, 6 Months and 12 Months

Secondary Outcomes

Measure	Description	Time Frame
Lower Extremity Activity Scale		Baseline, Post-Operatively at 2 Weeks, 6 Weeks, 3 Months, 6 Months and 12 Months
EuroQol		Baseline, Post-Operatively at 2 Weeks, 6 Weeks, 3 Months, 6 Months and 12 Months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Unilateral unstable intertrochanteric hip fracture without other lower extremity fractures.
Community and household ambulators with or without assistive devices.
Age 50 years or greater.

Exclusion Criteria:

Stable intertrochanteric hip fracture.
Bilateral or two or more lower extremity fractures.
Non-functional ambulators or non-ambulators.
Age less than 50 years.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients presenting with unilateral unstable intertrochanteric hip fracture (as defined by Hennepin County Medical Center intertrochanteric hip fracture classification system, Kyle et al, 1979) without other lower extremity fractures.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gregory Brown, M.D.	TRIA Orthopaedic Center, Park Nicollet Health Services	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sonoran Orthopaedic Trauma Surgeons, PLLC		Scottsdale	Arizona	85251	United States
University of California, Irvine