INTUIT Hip Fracture Outcome Study

This study has been terminated.
(Could not power primary endpoint due to lost to follow-up rate)
Sponsor:
Information provided by (Responsible Party):
Smith & Nephew, Inc.
ClinicalTrials.gov Identifier:
NCT00595634
First received: January 4, 2008
Last updated: March 31, 2014
Last verified: March 2014

January 4, 2008
March 31, 2014
January 2008
November 2013   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Mobility function as defined by the Timed Up & Go (TUG) frequency. [ Time Frame: Post-Operatively at 2 Weeks, 6 Weeks, 3 Months, 6 Months and 12 Months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00595634 on ClinicalTrials.gov Archive Site
  • Lower Extremity Activity Scale [ Time Frame: Baseline, Post-Operatively at 2 Weeks, 6 Weeks, 3 Months, 6 Months and 12 Months ] [ Designated as safety issue: No ]
  • EuroQol [ Time Frame: Baseline, Post-Operatively at 2 Weeks, 6 Weeks, 3 Months, 6 Months and 12 Months ] [ Designated as safety issue: No ]
  • Visual Analogue Score (VAS) [ Time Frame: Baseline, Post-Operatively at 2 Weeks, 6 Weeks, 3 Months, 6 Months and 12 Months ] [ Designated as safety issue: No ]
  • Adverse Event [ Time Frame: When necessary ] [ Designated as safety issue: No ]
  • Harris Hip Score [ Time Frame: Baseline, Post-Operatively at 2 Weeks, 6 Weeks, 3 Months, 6 Months and 12 Months ] [ Designated as safety issue: No ]
  • SF-36 [ Time Frame: Baseline, Post-Operatively at 2 Weeks, 6 Weeks, 3 Months, 6 Months and 12 Months ] [ Designated as safety issue: No ]
  • EuroQol [ Time Frame: Baseline, Post-Operatively at 2 Weeks, 6 Weeks, 3 Months, 6 Months and 12 Months ] [ Designated as safety issue: No ]
  • Visual Analogue Score (VAS) [ Time Frame: Baseline, Post-Operatively at 2 Weeks, 6 Weeks, 3 Months, 6 Months and 12 Months ] [ Designated as safety issue: No ]
  • Range of Motion [ Time Frame: Baseline, Post-Operatively at 2 Weeks, 6 Weeks, 3 Months, 6 Months and 12 Months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
INTUIT Hip Fracture Outcome Study
Intramedullary Nailing for Treatment of Unstable InterTrochanteric (INTUIT) Hip Fracture Outcome Study.

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

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.

Unstable Intertrochanteric Hip Fractures
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
92
November 2013
November 2013   (final data collection date for primary outcome measure)

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.
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00595634
03618-07-A
No
Smith & Nephew, Inc.
Smith & Nephew, Inc.
Not Provided
Principal Investigator: Gregory Brown, M.D. TRIA Orthopaedic Center, Park Nicollet Health Services
Smith & Nephew, Inc.
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP