Unstable Intertrochanteric Hip Fractures
Conditions
Keywords
Hip, Fracture, Intertrochanteric, intramedullary
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.
Interventions
None listed
Sponsors
Smith & Nephew, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mobility function as defined by the Timed Up & Go (TUG) frequency. | Baseline, Post-Operatively at 2 Weeks, 6 Weeks, 3 Months, 6 Months and 12 Months |
Secondary
| Measure | Time frame |
|---|---|
| Lower Extremity Activity Scale | Baseline, Post-Operatively at 2 Weeks, 6 Weeks, 3 Months, 6 Months and 12 Months |
| EuroQol | Baseline, Post-Operatively at 2 Weeks, 6 Weeks, 3 Months, 6 Months and 12 Months |
| Visual Analogue Score (VAS) | Baseline, Post-Operatively at 2 Weeks, 6 Weeks, 3 Months, 6 Months and 12 Months |
| Adverse Event | When necessary |
Countries
United States
Outcome results
None listed