FAITH Trial
Research type
Research Study
Full title
Fixation using Alternative Implants for the Treatment of Hip Fractures (FAITH): A Multi-Centre Randomised Trial Comparing Sliding Hip Screws and Cancellous Screws on Revision Surgery Rates in the Treatment of Femoral Neck Fractures.
IRAS ID
117810
Contact name
Julie Rowbotham
Contact email
Sponsor organisation
McMaster Univerisity
ISRCTN Number
ISRCTN25524122
Clinicaltrials.gov Identifier
Research summary
Hip fractures have a great impact on an individuals independence and quality of life. Many patients loose their independence after sustaining a hip fracture and about 20-30% require day to day care. Hip fractures are also associated with a high mortality rate of 25-30% within one year.
Certain types of hip fractures can be treated with internal fixation. Internal fixation involves joining the two pieces of bone back together using plates and/or screws. The two most common methods of internal fixation are multiple, so called cancellous, screws or a plate and screws device, called a sliding hip screw. Experimental data suggest that cancellous screws are better for the preservation of the blood supply to parts of the bone while the sliding hip screw resists bending forces better. It is, however, not clear if these experimental findings have an impact on patients' function and rate of further surgery.
This randomised controlled trial compares the two types of internal fixation, cancellous screws and sliding hip screw, in patients 50 years and older with a fracture neck of femur who were independently mobile prior to their fracture. Following informed consent patients will be randomised to receive either type of internal fixation. The operations will be carried out by surgeons experienced in both techniques. Patients will be independently assessed before their operation and at 1 and 10 weeks, 6 and 12 months during their clinic visits. Further telephone follow-up will be carried out at 9, 18 and 24 months. X-rays will be carried out as necessary.
The study's main outcome is the rate of further surgery, i.e. revision surgery, due to non-healing of the fracture, avascular necrosis, infection or implant failure. It further looks at the rate of complications following the surgery.
REC name
North East - York Research Ethics Committee
REC reference
13/NE/0102
Date of REC Opinion
24 Jun 2013
REC opinion
Further Information Favourable Opinion