INTUIT Hip Fracture Outcome Study

Terminated

• Conditions: Unstable Intertrochanteric Hip Fractures

• Registration Number: NCT00595634
• Lead Sponsor: Smith & Nephew, Inc.

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 available

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-01-04
• Study First Submitted QC: 2008-01-04
• Study First Posted: 2008-01-16
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-31
• Last Update Posted: 2014-04-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 92

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
EuroQol	Baseline, Post-Operatively at 2 Weeks, 6 Weeks, 3 Months, 6 Months and 12 Months
Lower Extremity Activity Scale	Baseline, Post-Operatively at 2 Weeks, 6 Weeks, 3 Months, 6 Months and 12 Months
Visual Analogue Score (VAS)	Baseline, Post-Operatively at 2 Weeks, 6 Weeks, 3 Months, 6 Months and 12 Months
Adverse Event	When necessary

Trial Locations

Locations (5)

Shrock Orthopedic Research, LLC; 🇺🇸 Fort Lauderdale, Florida, United States

Park Nicollet; 🇺🇸 Saint Louis Park, Minnesota, United States

Sonoran Orthopaedic Trauma Surgeons, PLLC; 🇺🇸 Scottsdale, Arizona, United States

University of California, Irvine; 🇺🇸 Orange, California, United States

Orthopaedic Center of Vero Beach; 🇺🇸 Vero Beach, Florida, United States