Condition category
Injury, Occupational Diseases, Poisoning
Date applied
08/09/2009
Date assigned
18/09/2009
Last edited
18/09/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.ihfrc.ca/

Contact information

Type

Scientific

Primary contact

Dr Mohit Bhandari

ORCID ID

Contact details

CLARITY Orthopaedic Research
293 Wellington Street North
Suite 110
Hamilton
L8L 8E7
Canada
bhandam@mcmaster.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00556842

Protocol/serial number

MCT-90168

Study information

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

Acronym

HEALTH

Study hypothesis

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

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)

Study design

Interventional treatment randomised double-blind (subject, outcomes assessor) parallel assignment multicentre efficacy study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Hip Fractures (displaced femoral neck fractures)

Intervention

Total hip arthroplasty versus hemi-arthroplasty. Patient followed for 2 years post-operatively.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Revision surgery, measured 2 years after original surgery

Secondary outcome measures

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
2. Complications, including mortality, dislocation, infection, femoral fracture, deep venous thrombosis, and prosthesis loosening, measured 2 years after original surgery
3. Quality of life, measured 2 years after original surgery using 12-item short form health survey (SF-12) and EuroQoL (EQ-5D) administered at 1, 2, 10 weeks, and 6, 9, 12, 18, 24 months

Overall trial start date

01/03/2009

Overall trial end date

30/03/2012

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

2500

Participant 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

Recruitment start date

01/03/2009

Recruitment end date

30/03/2012

Locations

Countries of recruitment

Canada, Netherlands, United States of America

Trial participating centre

CLARITY Orthopaedic Research
Hamilton
L8L 8E7
Canada

Sponsor information

Organisation

McMaster University (Canada)

Sponsor details

293 Wellington Street North
Suite 110
Hamilton
Ontario
L8L 8E7
Canada

Sponsor type

University/education

Website

http://www.mcmaster.ca/

Funders

Funder type

Research organisation

Funder name

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) (USA)

Alternative name(s)

NIAMS

Funding Body Type

government organisation

Funding Body Subtype

federal/national government

Location

United States of America

Funder name

Hamilton Health Sciences (Canada)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-90168)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes