INTUIT Hip Fracture Outcome Study

Unstable Intertrochanteric Hip Fractures Clinical Trial

— INTUIT  

Official title:

Intramedullary Nailing for Treatment of Unstable InterTrochanteric (INTUIT) Hip Fracture Outcome Study.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00595634
• Other study ID #: 03618-07-A
• Status: Terminated
• Phase: N/A
• First received: January 4, 2008
• Last updated: March 31, 2014
• Start date: January 2008
• Est. completion date: November 2013

Study information

• Verified date: March 2014
• Source: Smith & Nephew, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 92
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Fractures, Bone
• Hip Fractures
• Unstable Intertrochanteric Hip Fractures

Locations

Country	Name	City	State
United States	Shrock Orthopedic Research, LLC	Fort Lauderdale	Florida
United States	University of California, Irvine	Orange	California
United States	Park Nicollet	Saint Louis Park	Minnesota
United States	Sonoran Orthopaedic Trauma Surgeons, PLLC	Scottsdale	Arizona
United States	Orthopaedic Center of Vero Beach	Vero Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Smith & Nephew, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Lower Extremity Activity Scale		Baseline, Post-Operatively at 2 Weeks, 6 Weeks, 3 Months, 6 Months and 12 Months	No
Secondary	EuroQol		Baseline, Post-Operatively at 2 Weeks, 6 Weeks, 3 Months, 6 Months and 12 Months	No
Secondary	Visual Analogue Score (VAS)		Baseline, Post-Operatively at 2 Weeks, 6 Weeks, 3 Months, 6 Months and 12 Months	No
Secondary	Adverse Event		When necessary	No

External Links

•   TRIA Orthopaedic Center