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INTUIT Hip Fracture Outcome Study (INTUIT)

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ClinicalTrials.gov Identifier: NCT00595634
Recruitment Status : Terminated (Could not power primary endpoint due to lost to follow-up rate)
First Posted : January 16, 2008
Last Update Posted : April 1, 2014
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
Unstable Intertrochanteric Hip Fractures

Study Type : Observational
Actual Enrollment : 92 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Intramedullary Nailing for Treatment of Unstable InterTrochanteric (INTUIT) Hip Fracture Outcome Study.
Study Start Date : January 2008
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Mobility function as defined by the Timed Up & Go (TUG) frequency. [ Time Frame: Baseline, Post-Operatively at 2 Weeks, 6 Weeks, 3 Months, 6 Months and 12 Months ]

Secondary Outcome Measures :
  1. Lower Extremity Activity Scale [ Time Frame: Baseline, Post-Operatively at 2 Weeks, 6 Weeks, 3 Months, 6 Months and 12 Months ]
  2. EuroQol [ Time Frame: Baseline, Post-Operatively at 2 Weeks, 6 Weeks, 3 Months, 6 Months and 12 Months ]
  3. Visual Analogue Score (VAS) [ Time Frame: Baseline, Post-Operatively at 2 Weeks, 6 Weeks, 3 Months, 6 Months and 12 Months ]
  4. Adverse Event [ Time Frame: When necessary ]


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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00595634


Locations
United States, Arizona
Sonoran Orthopaedic Trauma Surgeons, PLLC
Scottsdale, Arizona, United States, 85251
United States, California
University of California, Irvine
Orange, California, United States, 92868
United States, Florida
Shrock Orthopedic Research, LLC
Fort Lauderdale, Florida, United States, 33316
Orthopaedic Center of Vero Beach
Vero Beach, Florida, United States, 32960
United States, Minnesota
Park Nicollet
Saint Louis Park, Minnesota, United States, 55426
Sponsors and Collaborators
Smith & Nephew, Inc.
Investigators
Principal Investigator: Gregory Brown, M.D. TRIA Orthopaedic Center, Park Nicollet Health Services

Additional Information:
Responsible Party: Smith & Nephew, Inc.
ClinicalTrials.gov Identifier: NCT00595634     History of Changes
Other Study ID Numbers: 03618-07-A
First Posted: January 16, 2008    Key Record Dates
Last Update Posted: April 1, 2014
Last Verified: March 2014

Keywords provided by Smith & Nephew, Inc.:
Hip
Fracture
Intertrochanteric
intramedullary

Additional relevant MeSH terms:
Fractures, Bone
Hip Fractures
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries