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
  Purpose

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
Unstable Intertrochanteric Hip Fractures

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Intramedullary Nailing for Treatment of Unstable InterTrochanteric (INTUIT) Hip Fracture Outcome Study.

Resource links provided by NLM:


Further study details as provided by Smith & Nephew, Inc.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 92
Study Start Date: January 2008
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
No publications provided

Responsible Party: Smith & Nephew, Inc.
ClinicalTrials.gov Identifier: NCT00595634     History of Changes
Other Study ID Numbers: 03618-07-A
Study First Received: January 4, 2008
Last Updated: March 31, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 23, 2014