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 number	NCT00556842
Secondary identifying numbers	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

Not provided at time of registration

Study website

Contact information

Dr Mohit Bhandari
Scientific

CLARITY Orthopaedic Research
293 Wellington Street North, Suite 110
Hamilton
L8L 8E7
Canada

Email	bhandam@mcmaster.ca

Study information

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
Study setting(s)	Hospital
Study type	Treatment
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 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(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)
Condition	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	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 study start date	01/03/2009
Overall study end date	30/03/2012

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	Both
Target number of participants	2500
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 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

Study participating centre

CLARITY Orthopaedic Research

Hamilton
L8L 8E7
Canada

Sponsor information

McMaster University (Canada)
University/education

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

Website	http://www.mcmaster.ca/
"ROR"	https://ror.org/02fa3aq29

Funders

Funder type

Research organisation

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) (USA)
Government organisation / National government

Alternative name(s): The National Institute of Arthritis and Musculoskeletal and Skin Diseases, NIH National Institute of Arthritis and Musculoskeletal and Skin Diseases, NIH/National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Institute of Arthritis & Musculoskeletal & Skin Diseases, Instituto Nacional de Artritis y Enfermedades Musculoesqueléticas y de la Piel, NIAMS
Location: United States of America

Hamilton Health Sciences (Canada)

No information available

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

No information available

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	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

Editorial Notes

23/05/2022: ClinicalTrials.gov results added.
19/02/2019: Publication reference added.