N/A
N=1,108
Using Alternative Implants for the Surgical Treatment of Hip Fractures (The FAITH Study)
Femoral Neck Fractures
Bottom Line
View on ClinicalTrials.gov: NCT00761813 ↗Enrolled (actual)
1,108
Serious AEs
20.3%
Results posted
Jan 2018
Primary outcome: Primary: Revision Surgery — 107; 117 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Open reduction internal fixation (ORIF) with single sliding hip screw (Device); ORIF with multiple cancellous screws (Device)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- University of Minnesota
- Primary completion
- Mar 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Revision Surgery |
107; 117 | — |
| SECONDARY Quality of Life |
41.6; 41.4; 40.97; 39.75; 0.79; 0.80 | — |
| SECONDARY Complications, Including Avascular Necrosis, Nonunion, and Infection |
50; 28; 33; 33; 10; 9 | 0.05 |
Summary
Each year, hip fracture, an injury that can impair independence and quality of life, occurs in about 280,000 Americans and 36,000 Canadians. The annual healthcare costs associated with this injury are expected to soon reach $9.8 billion in the United States and $650 million in Canada. It is important to have in place optimal practice guidelines for the surgical handling of this injury. One type of hip fracture, called a femoral neck fracture, is often treated with a surgical procedure called internal fixation. When performing internal fixation, most orthopaedic surgeons favor using multiple small diameter screws over using a single large diameter screw with a sliding plate. However, use of the sliding hip screw might in fact result in fewer complications after surgery and reduce the need for a second surgery, called a revision surgery. This study will compare the two different surgical procedures to determine which one results in better outcomes after surgery.
Eligibility Criteria
Inclusion Criteria
- Fracture of femoral neck
- Operative treatment within 4 days for displaced fractures
- Operative treatment within 7 days for nondisplaced fractures
- Ambulatory before the injury
- Low energy trauma, such as falls from a sitting or standing position
- No other major trauma
Exclusion Criteria
- Unsuited for both surgical treatments
- Associated major injuries of the lower extremities
- Retained hardware around the hip
- Infection around the hip
- Bone metabolic disorder (except for osteoporosis)
- Moderate or severe cognitive impairment
- Parkinson's disease or dementia
- Unable to complete the 2-year follow-up
Data sourced from ClinicalTrials.gov (NCT00761813). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.