Mode
Text Size
Log in / Sign up
N/A N=1,108 Randomized Single-blind Treatment

Using Alternative Implants for the Surgical Treatment of Hip Fractures (The FAITH Study)

Femoral Neck Fractures

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

Back to search