Clinical trial NCT00595634: INTUIT Hip Fracture Outcome Study
Official title: Intramedullary Nailing for Treatment of Unstable InterTrochanteric (INTUIT) Hip Fracture Outcome Study.
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Unstable Intertrochanteric Hip Fractures
Keywords: Hip
Fracture
Intertrochanteric
intramedullary
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
First posted: 2008-01-16
Enrollment: 92
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

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.


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.

Primary outcomes:
measure: Mobility function as defined by the Timed Up & Go (TUG) frequency.
timeFrame: Baseline, Post-Operatively at 2 Weeks, 6 Weeks, 3 Months, 6 Months and 12 Months
Secondary outcomes:
measure: Lower Extremity Activity Scale
timeFrame: Baseline, Post-Operatively at 2 Weeks, 6 Weeks, 3 Months, 6 Months and 12 Months
measure: EuroQol
timeFrame: Baseline, Post-Operatively at 2 Weeks, 6 Weeks, 3 Months, 6 Months and 12 Months
measure: Visual Analogue Score (VAS)
timeFrame: Baseline, Post-Operatively at 2 Weeks, 6 Weeks, 3 Months, 6 Months and 12 Months
measure: Adverse Event
timeFrame: When necessary
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Sonoran Orthopaedic Trauma Surgeons, PLLC
state: Arizona
city: Orange
country: United States
facility: University of California, Irvine
state: California
city: Fort Lauderdale
country: United States
facility: Shrock Orthopedic Research, LLC
state: Florida
city: Vero Beach
country: United States
facility: Orthopaedic Center of Vero Beach
state: Florida
city: Saint Louis Park
country: United States
facility: Park Nicollet
state: Minnesota
Study officials:
affiliation: TRIA Orthopaedic Center, Park Nicollet Health Services
name: Gregory Brown, M.D.
role: PRINCIPAL_INVESTIGATOR
References: