Comparing total hip arthroplasty and hemi-arthroplasty on revision surgery and quality of life in adults with displaced hip fractures: the HEALTH study
| ISRCTN | ISRCTN59890378 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN59890378 |
| ClinicalTrials.gov (NCT) | NCT00556842 |
| Protocol serial number | MCT-90168 |
| Sponsor | McMaster University (Canada) |
| Funders | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) (USA), Hamilton Health Sciences (Canada), The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands), Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-90168) |
- Submission date
- 08/09/2009
- Registration date
- 18/09/2009
- Last edited
- 23/05/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Mohit Bhandari
Scientific
Scientific
CLARITY Orthopaedic Research
293 Wellington Street North, Suite 110
Hamilton
L8L 8E7
Canada
| bhandam@mcmaster.ca |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Interventional treatment randomised double-blind (subject, outcomes assessor) parallel assignment multicentre efficacy study |
| Secondary study design | Randomised controlled trial |
| Scientific title | Hip fracture Evaluation with ALternatives of Total Hip arthroplasty versus hemi-arthroplasty (HEALTH): a multicentre randomised trial comparing total hip arthroplasty and hemi-arthroplasty on revision surgery and quality of life in patients with displaced femoral neck fractures |
| Study acronym | HEALTH |
| Study objectives | We hypothesise that total hip arthroplasty will have similar or lower rates of revision surgery and higher functional outcome scores at 24 months compared with hemi-arthroplasty. |
| Ethics approval(s) | 1. Canada: Hamilton Health Sciences Research Ethics Board approved on the 20th May 2008 (ref: 06-151) 2. Netherlands: Medical Research Ethics Committee approved on the 14th October 2008 (ref: NL12833.078.06 [local nr MEC-2006-182]) 3. USA: Institutional Review Board of Boston University Medical Campus approved on the 12th May 2008 (ref: H-27108) |
| Health condition(s) or problem(s) studied | Hip Fractures (displaced femoral neck fractures) |
| Intervention | Total hip arthroplasty versus hemi-arthroplasty. Patient followed for 2 years post-operatively. |
| Intervention type | Other |
| Primary outcome measure(s) |
Revision surgery, measured 2 years after original surgery |
| Key secondary outcome measure(s) |
1. Function, measured 2 years after original surgery using Western Ontario McMaster Osteoarthritis Index (WOMAC) and Timed Up and Go Test (TUG) administered at 1, 2, 10 weeks, and 6, 9, 12, 18, 24 months |
| Completion date | 30/03/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | All |
| Target sample size at registration | 2500 |
| Key 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 or lateral hip radiographs, computed tomography, or magnetic resonance imaging (MRI) 3. Displaced fracture that is not, in the judgment of the attending surgeon, optimally managed by reduction and internal fixation 4. Operative treatment within 3 days (i.e. 72 hours) of the patient being medically cleared for surgery 5. Patient was ambulatory prior to fracture, though they may have used an aid such as a cane or a walker 6. Anticipated medical optimization for arthroplasty of the hip 7. Provision of informed consent by patient or proxy 8. Low energy fracture (defined as a fall from standing height) 9. No other major trauma 10. Assurance that surgeons with expertise in both total hip arthroplasty and hemiarthroplasty are available to perform surgery. Note: Surgeons do not need to be experts in both techniques. |
| Key exclusion criteria | 1. Patient not suitable for arthroplasty (e.g. inflammatory arthritis, rheumatoid arthritis, pathologic fracture (secondary to cancer), or severe osteoarthritis of the hip) 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 that will interfere with arthroplasty 4. Infection around the hip (soft tissue or bone) 5. Patients with a disorder of bone metabolism other than osteoporosis (i.e., Paget's disease, renal osteodystrophy, osteomalacia) 6. Patients with a previous history of frank dementia that would interfere with assessment of the primary outcome (i.e., revision surgery at 2 years) 7. Likely problems, in the judgment of the investigators, with maintaining follow-up (i.e., patients with no fixed address, report a plan to move out of town, or intellectually challenged patients without adequate family support) 8. Attending surgeon believes the patient should be excluded because enrolled in another ongoing drug or surgical intervention trial 9. Any other reason |
| Date of first enrolment | 01/03/2009 |
| Date of final enrolment | 30/03/2012 |
Locations
Countries of recruitment
- Canada
- Netherlands
- United States of America
Study participating centre
CLARITY Orthopaedic Research
Hamilton
L8L 8E7
Canada
L8L 8E7
Canada
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 13/02/2015 | Yes | No | |
| Basic results | 07/07/2020 | 23/05/2022 | No | No | |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
23/05/2022: ClinicalTrials.gov results added.
19/02/2019: Publication reference added.
