INTUIT Hip Fracture Outcome Study
This study is currently recruiting participants.
Verified April 2013 by Smith & Nephew, Inc.
Sponsor:
Smith & Nephew, Inc.
Information provided by (Responsible Party):
Smith & Nephew, Inc.
ClinicalTrials.gov Identifier:
NCT00595634
First received: January 4, 2008
Last updated: April 1, 2013
Last verified: April 2013
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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 ]
| Estimated Enrollment: | 125 |
| Study Start Date: | January 2008 |
| Estimated Study Completion Date: | July 2014 |
| Estimated Primary Completion Date: | July 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00595634
Contacts
| Contact: Stacy Leake-Gardner, RN, BSN | 800) 821-5700 ext 5100 | stacy.leake-gardner@smith-nephew.com |
| Contact: Cathy Newbill, CCRA | (800) 821-5700 ext 6422 | cathy.newbill@smith-nephew.com |
Locations
| United States, Arizona | |
| The MORE Foundation (The CORE Institute) | Not yet recruiting |
| Phoenix,, Arizona, United States, 85027 | |
| Contact: Bethany Larsen 623-537-5695 bethany.larsen@thecoreinstitute.com | |
| Principal Investigator: Arash Araghi, MD | |
| Sonoran Orthopaedic Trauma Surgeons, PLLC | Active, not recruiting |
| Scottsdale, Arizona, United States, 85251 | |
| United States, California | |
| University of California, Irvine | Terminated |
| Orange, California, United States, 92868 | |
| United States, Florida | |
| Shrock Orthopedic Research, LLC | Recruiting |
| Fort Lauderdale, Florida, United States, 33316 | |
| Principal Investigator: Kevin Shrock, MD | |
| Orthopaedic Center of Vero Beach | Recruiting |
| Vero Beach, Florida, United States, 32960 | |
| Principal Investigator: Richard Steinfeld, MD | |
| United States, Minnesota | |
| Park Nicollet | Recruiting |
| Saint Louis Park, Minnesota, United States, 55426 | |
| Principal Investigator: Gregory Brown, M.D. | |
| United States, Texas | |
| The University of Texas Health Science Center at San Antonio | Not yet recruiting |
| San Antonio, Texas, United States, 78229-3900 | |
| Contact: Ruth Wright, RN, BSN 210-567-5162 WrightR3@uthscsa.edu | |
| Principal Investigator: Animesh Agarwal, MD | |
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: | April 1, 2013 |
| 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 May 23, 2013