INTUIT Hip Fracture Outcome Study

NCT ID: NCT00595634

Last Updated: 2014-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Total Enrollment

92 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-01-31

Study Completion Date

2013-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Unstable Intertrochanteric Hip Fractures

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Smith & Nephew, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Gregory Brown, M.D.

Role: PRINCIPAL_INVESTIGATOR

TRIA Orthopaedic Center, Park Nicollet Health Services

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Sonoran Orthopaedic Trauma Surgeons, PLLC

Scottsdale, Arizona, United States

Site Status

University of California, Irvine

Orange, California, United States

Site Status

Shrock Orthopedic Research, LLC

Fort Lauderdale, Florida, United States

Site Status

Orthopaedic Center of Vero Beach

Vero Beach, Florida, United States

Site Status

Park Nicollet

Saint Louis Park, Minnesota, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Related Links

Access external resources that provide additional context or updates about the study.

http://www.tria.com/

TRIA Orthopaedic Center

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

03618-07-A

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.