ObjectiveOur primary objective is to assess the impact of sliding hip screws versus cannulated screw fixation on rates of revision surgery at 2 years in individuals with femoral neck fractures. Our secondary objective is to determine the impact on…
ID
Source
Brief title
Condition
- Fractures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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).
Background summary
Rationale:
Hip fractures occur in about 18.000 Dutch patients (over 350 per week) per
year. . The estimated annual health care costs will reach a staggering $9.8
billion in the United States by 2040. Hip fractures are associated with a 30%
mortality rate and profound temporary and sometimes permanent impairment of
independence and quality of life. Worldwide, 4.5 million persons are disabled
from hip fractures yearly with an expected increase to 21 million persons
living with disability in the next 40 years. Experimental data suggest that
cancellous screws offer greater preservation of blood supply, while sliding hip
screws provide greater biomechanical stability to bending stresses. About 50%
of hip fractures represent femoral neck fractures.
Need for a Definitive Randomized Controlled Trial:
First, although current opinion among orthopaedic surgeons favours the use of
cancellous screws over sliding hip screws, there remains sufficient divergence
in perceptions and sufficient interest to resolve this issue to warrant a large
randomized controlled trial. Second, despite the popularity of cancellous screw
fixation, there is a strong biologic rationale supporting the sliding hip
screws, a more biomechanically stable construct, in older patients with
osteopenia or osteoporosis. Third, while our meta-analysis provides indirect
and direct evidence that a sliding hip screw may reduce revision surgery rates,
the evidence remains far from definitive. The current best estimate of
treatment effect with sliding hip screws is based upon small trials with
methodological limitations including unconcealed randomization and lack of
blinding. The resulting estimates include wide confidence intervals (i.e.,
displaced fractures: RRR=27%, 95%CI: 48%, -4%, P=0.08). Whatever approach to
internal fixation proves best, a large proportion of patients will continue to
need revision surgery that is associated with high morbidity and appreciable
mortality.
Study objective
Objective
Our primary objective is to assess the impact of sliding hip screws versus
cannulated screw fixation on rates of revision surgery at 2 years in
individuals with femoral neck fractures. Our secondary objective is to
determine the impact on health-related quality of life (Short Form-12, SF-12),
functional outcomes (Western Ontario McMaster Osteoarthritis Index, WOMAC), and
health utility (Health Utilities Index Mark III,HUII3).
Hypothesis
We hypothesize that sliding hip screws will have lower rates of revision
surgery (primary outcome) and higher functional outcome scores (secondary
outcome) at 24 months compared with cancellous screws.
Study design
We propose a multi-centre, concealed randomized trial design using minimization
to determine patient allocation. Surgeons across Canada, United States, South
America, Europe, Australia, and Asia will participate. Surgeons will use one of
two surgical strategies in 2,500 patients who have sustained a femoral neck
fracture. The first strategy involves fixation of the fracture with multiple
small diameter cancellous screws (i.e., cancellous screw group). The second
treatment strategy involves fixation of the fracture with a single larger
diameter screw with a sideplate (i.e., sliding hip screw group).
Study personnel will monitor critical aspects of peri-operative care and
rehabilitation for protocol deviations. We will assess patients at hospital
discharge, 2 weeks, 10 weeks, 3 months, 6 months, 9 months, 12 months, 18
months, and 24 months after surgery. We will independently adjudicate revision
surgery rates at regular intervals up to 2 years.
Intervention
Sliding hip screw or multiple cannulated screws.
Study burden and risks
Surgeons worldwide are currently using both surgical techniques (i.e., sliding
hip screws and cancellous screws). Cancellous screws or similar types of screws
(or pins) have been used for over 5 decades in the management of femoral neck
fractures. Sliding hip screws have had a similar history in the management of
inter-trochanteric hip fractures. As with any surgical procedure of the lower
extremity, potential risks include wound infection, deep vein thrombosis,
neurovascular injury, compartment syndrome, and death. All patients eligible
for the trial, however, require surgical treatment. We will monitor all adverse
events following treatment across both internal fixation arms. Our independent
Data Monitoring Committee (DMC) will review this information at regular
intervals.
Postbus 2060
3000 CA Rotterdam
NL
Postbus 2060
3000 CA Rotterdam
NL
Listed location countries
Age
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
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL13205.078.06 |