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Fixation using Alternative Implants for the Treatment of Hip Fractures (FAITH): A Multi-Centre Randomized Trial Comparing Sliding Hip Screws and Cancellous Screws on Revision Surgery Rates and Quality of Life in the Treatment of Femoral Neck Fractures

Fixation using Alternative Implants for the Treatment of Hip Fractures (FAITH): A Multi-Centre Randomized Trial Comparing Sliding Hip Screws and Cancellous Screws on Revision Surgery Rates and Quality of Life in the Treatment of Femoral Neck Fractures - FAITH

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON30133
Enrollment
150
Registered
2006-09-11
Start date
2008-01-01
Completion date
Unknown
Last updated
2024-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

broken hip hip fracture

Interventions

Sliding hip screw or multiple cannulated screws.

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Adult men or women aged 50 years and older (with no upper age limit). 2. Fracture of the femoral neck confirmed with either anteroposterior and lateral hip radiographs, computed tomography, or magnetic resonance imaging (MRI). 3. Any degree of displacement (i.e., undisplaced or displaced) of the femoral neck fracture that can be closed reduced. 4. Operative treatment of displaced fractures within 2 days (i.e., 48 hours) of presenting to the emergency room. 5. Operative treatment of undisplaced fractures within 7 days of presenting to the emergency room. 6. Patient was ambulatory prior to fracture, though they may have used an aid such as a cane or a walker. 7. Anticipated medical optimalization for operative fixation of the hip by anesthesia and/or internal medicine team. 8. Provision of informed consent by patient or legal guardian. 9. Low energy fracture (defined as a fall from standing height). 10. No other major trauma.

Exclusion criteria

Exclusion criteria: 1. Patients not suitable for internal fixation (i.e., severe osteoarthritis, rheumatoid arthritis, or pathologic fracture). 2. Associated major injuries of the lower extremity (i.e., ipsilateral or contralateral fractures of the foot, ankle, tibia, fibula, knee, or femur; dislocations of the ankle, knee, or hip; or femoral head defects or fracture). 3. Retained hardware around the affected hip. 4. Infection around the hip (i.e., soft tissue or bone). 5. Patients with disorders of bone metabolism other than osteoporosis (i.e., Paget*s disease, renal osteodystrophy). 6. Moderate or severe cognitively impaired patients (i.e., Six Item Screener with 3 or more errors). 7. Patients with Parkinson*s disease (or dementia) severe enough to increase the likelihood of falling or severe enough to compromise rehabilitation. 8. Likely problems, in the judgment of the investigators, with maintaining follow-up.

Design outcomes

Primary

MeasureTime frame
Revision surgery within 2 years of initial surgery to promote fracture healing, relieve pain, treat infection, or improve function include the following: 1. Implant removal prior to fracture healing (to achieve union). 2. Revision surgery with another internal fixation implant. 3. Revision surgery to arthroplasty. 4. Incision and drainage for deep infection at the bone implant.

Secondary

MeasureTime frame
We will measure functional outcome and quality of life using self-administered and interview-administered questionnaires. Functional outcome questionnaires will include a generic health status measurement instrument (SF-12), a hip function and pain questionnaire (WOMAC), and a generic utility measure (HUI3). We will further report the effect of sliding hip screws versus cancellous screws on complications including mortality, AVN, nonunion, implant breakage or failure, implant removal after fracture healing to minimize pain, and infection (i.e., superficial and deep).

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)