Unstable Intertrochanteric Hip FracturesINTUITNCT00595634
INTUIT Hip Fracture Outcome Study
An observational study of Unstable Intertrochanteric Hip Fractures, run by Smith & Nephew, Inc. at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Unstable Intertrochanteric Hip Fractures
- How many people
- 92 participants
- Where
- 5 sitesUnited States
- Study dates
- Jan 2008to Nov 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Unilateral unstable intertrochanteric hip fracture without other lower extremity fractures.
- Community and household ambulators with or without assistive devices.
- Age 50 years or greater.
Who cannot join
- Stable intertrochanteric hip fracture.
- Bilateral or two or more lower extremity fractures.
- Non-functional ambulators or non-ambulators.
- Age less than 50 years.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Shrock Orthopedic Research, LLC
Fort Lauderdale, Florida, 33316
University of California, Irvine
Orange, California, 92868
Park Nicollet
Saint Louis Park, Minnesota, 55426
Sonoran Orthopaedic Trauma Surgeons, PLLC
Scottsdale, Arizona, 85251
Orthopaedic Center of Vero Beach
Vero Beach, Florida, 32960
About this study
Official title: 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.
- Conditions
- Unstable Intertrochanteric Hip Fractures
- Keywords
- Hip, Fracture, Intertrochanteric, intramedullary
- Medical subject headings
- Fractures, Bone
What is being measured
The primary outcome is the main question the study is designed to answer.
Mobility function as defined by the Timed Up & Go (TUG) frequency.
Measured: Baseline, Post-Operatively at 2 Weeks, 6 Weeks, 3 Months, 6 Months and 12 Months
Secondary outcomes (4)
Lower Extremity Activity Scale
Measured: Baseline, Post-Operatively at 2 Weeks, 6 Weeks, 3 Months, 6 Months and 12 Months
EuroQol
Measured: Baseline, Post-Operatively at 2 Weeks, 6 Weeks, 3 Months, 6 Months and 12 Months
Visual Analogue Score (VAS)
Measured: Baseline, Post-Operatively at 2 Weeks, 6 Weeks, 3 Months, 6 Months and 12 Months
Adverse Event
Measured: When necessary
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2008 (estimated)
- Study startJan 2008
- Primary completionNov 2013
- Study completionNov 2013
Why it stopped: Could not power primary endpoint due to lost to follow-up rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unstable Intertrochanteric Hip FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smith & Nephew, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gregory Brown, M.D., Principal investigator, TRIA Orthopaedic Center, Park Nicollet Health Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00595634
- Sponsor's protocol ID
- 03618-07-A
- Acronym
- INTUIT
- Status last verified
- Mar 2014
- First submitted
- 4 Jan 2008
- Last updated
- 1 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intramedullary Nailing for Treatment of Unstable InterTrochanteric (INTUIT) Hip Fracture Outcome Study.
- ClinicalTrials.gov ID
- NCT00595634
- Acronym / sponsor ID
- INTUIT / 03618-07-A
- Conditions
- Unstable Intertrochanteric Hip Fractures
- Keywords
- Hip, Fracture, Intertrochanteric, intramedullary
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Could not power primary endpoint due to lost to follow-up rate
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Smith & Nephew, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 16 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Unilateral unstable intertrochanteric hip fracture without other lower extremity fractures.
- Community and household ambulators with or without assistive devices.
- Age 50 years or greater.
Key exclusion criteria (4 listed)
- Stable intertrochanteric hip fracture.
- Bilateral or two or more lower extremity fractures.
- Non-functional ambulators or non-ambulators.
- Age less than 50 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
4 secondary outcomes
Lower Extremity Activity Scale
Time frame: Baseline, Post-Operatively at 2 Weeks, 6 Weeks, 3 Months, 6 Months and 12 Months
EuroQol
Time frame: Baseline, Post-Operatively at 2 Weeks, 6 Weeks, 3 Months, 6 Months and 12 Months
Visual Analogue Score (VAS)
Time frame: Baseline, Post-Operatively at 2 Weeks, 6 Weeks, 3 Months, 6 Months and 12 Months
Adverse Event
Time frame: When necessary
Results and safety
The study was stopped early (reason given: Could not power primary endpoint due to lost to follow-up rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2014.
- TRIA Orthopaedic CenterLink provided by the sponsor.
Related trials for Unstable Intertrochanteric Hip Fractures
Recruiting
InterTAN: Integrated Dual Screw Design Improve Biomechanics/Function Following Fixation Surgery
Fracture of Hip
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregory Brown, M.D. principal investigator
TRIA Orthopaedic Center, Park Nicollet Health Services
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Unstable Intertrochanteric Hip Fractures, run by Smith & Nephew, Inc. at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Could not power primary endpoint due to lost to follow-up rate). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2014.