The primary objective is to assess the impact of total hip arthroplasty versus hemi-arthroplasty on rates of secondary procedures at 2 years in individuals with displaced femoral neck fractures.
ID
Source
Brief title
Condition
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome is any unplanned secondary procedure within 2 years of the
initial joint replacement surgery.
Secondary outcome
Secondary outcomes will include:
Functional outcome
quality of life
mortality
hip-related complications.
Background summary
This is a multi-centre, blinded,randomized control trial to evaluate two
alternative approaches (total hip arthroplasty and hemiarthroplasty)
for treating displaced femoral neck fractures in elderly patients. Although
current opinion among orthopaedic surgeons favours the use of arthroplasty for
displaced femoral neck fractures, there is lack of agreement on which type of
arthroplasty is optimal. The rationale for
this study is driven by: 1) the high incidence and serious consequences of hip
fractures; 2) the orthopaedic community*s uncertainty about the optimal type of
arthroplasty; 3) a feasible and efficient study design; and 4) extensive
support for the trial.
Study objective
The primary objective is to assess the impact of total hip arthroplasty versus
hemi-arthroplasty on rates of secondary procedures at 2 years in individuals
with displaced femoral neck fractures.
Study design
HEALTH is a multi-centre, concealed *expertise-based* randomized trial design
using minimization to determine patient allocation. Surgeons across
North America, Europe, Asia, and Australia will participate. Patients who have
sustained a displaced femoral neck fracture will be randomized to one of two
surgical interventions. The first surgical intervention involves total hip
arthroplasty (i.e., replacement of the femoral head and hip socket). The second
surgical intervention involves a hemi-arthroplasty (i.e., replacement of the
femoral head only). Each participating site will have on staff surgeons with
expertise in both interventions to ensure adherence to the expertise-based
design. Study personnel will monitor critical aspects of peri-operative care
and rehabilitation. We will assess patients at hospital admission (baseline), 1
week, 10 weeks, 6 months, 9 months, 12 months, 18 months, and 24 months after
surgery. Fracture eligibility when in doubt, technical placement of prostheses,
secondary procedures, fracture-related complications, and deaths will be
independently adjudicated.
Intervention
A total hip arthroplasty versus a hemi-arthroplasty
Study burden and risks
The patient will need about 2 hours to complete the questionnaires. Also, two
extra radiographs will be made.
Wellington St. N 293
Hamilton ON L8L 8E7
CA
Wellington St. N 293
Hamilton ON L8L 8E7
CA
Listed location countries
Age
Inclusion criteria
1. Aged 65 years or older.
2. Have a femoral neck fracture confirmed with anteroposterior (AP) and/or
lateral hip radiographs, or computed tomography (CT), or magnetic resonance
imaging (MRI).
3. Have a displaced fracture that is not repairable via reduction and internal
fixation in the judgment of the attending surgeon
4. The operative treatment will take place within 3 days (i.e. 72 hours) of the
patient being medically cleared for surgery.
5. Be ambulatory prior to fracture, though they may have used an aid.
6. Have anticipated medical optimization for arthroplasty of the hip (i.e. patient is
cleared for surgery).
7. Provides informed consent
8. Have a low energy fracture (defined as a fall from standing height).
9. Have no other major trauma (defined as an Injury Severity Score <17)
10. Surgeons with expertise in both THA and HA are available to perform the
surgery
Exclusion criteria
1. The patient is not suitable for hemi*arthroplasty (e.g., inflammatory arthritis,
rheumatoid arthritis, pathologic fracture [secondary to cancer], or severe
osteoarthritis of the hip).
2. The patient has associated major injuries of the lower extremity (e.g. 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. The patient has retained hardware around the affected hip that will interfere
with arthroplasty.
4. The patient has a soft tissue or bone infection around the hip.
5. The patient has a bone metabolism disorder other than osteoporosis (e.g.,
Paget*s disease, renal osteodystrophy, osteomalacia).
6. The patient has a previous history of frank dementia that would interfere with
assessment of the primary outcome (i.e. revision surgery at 2 years).
7. There may be problems with maintaining follow*up (e.g., patients with no fixed
address, report a plan to move out of town, or intellectually challenged patients
without adequate family support), in the judgment of the attending surgeon.
8. The fracture occurred as a result of an act of violence.
9. The patient is participating in another ongoing drug or surgical intervention
trial.
10. The attending surgeon believes that there is another reason to exclude the
patient.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| Other | clinical trials.gov |
| CCMO | NL52941.075.15 |