Condition category
Injury, Occupational Diseases, Poisoning
Date applied
13/06/2008
Date assigned
13/06/2008
Last edited
13/06/2008
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

McMaster University
293 Wellington Street North
Suite 110
Hamilton
Ontario
L8L 8E7
Canada
+1 905 527 4322 ext. 44490
bhandam@mcmaster.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

MCT-87771

Study information

Scientific title

Acronym

FAITH

Study hypothesis

We hypothesise that sliding hip screws will have lower rates of revision surgery (primary outcome) and higher functional outcome scores (secondary outcome) compared with cancellous screws.

Ethics approval

Ethics approval received from the Research Ethics Board of McMaster University on the 23rd November 2006 (ref: 06-402).

Study design

Single blind (study participant, outcome assessor, data analyst, adjudication committee), randomised trial using minimisation

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Femoral neck fractures

Intervention

Sliding hip screw fixation versus multiple cancellous screw fixation.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Revisions surgery as measured at 12 months.

Secondary outcome measures

1. Health related quality of life (12-item short form health survey [SF-12]), measured post-operatively at 1 week, 2 weeks, 3 months, 6 months, 9 months and 12 months
2. Functional outcomes (Western Ontario and McMaster Osteoarthritis Index [WOMAC]), measured post-operatively at 1 week, 2 weeks, 3 months, 6 months, 9 months and 12 months
3. Health outcomes (European quality of life instrument [EQ-5D]), measured post-operatively at 1 week, 2 weeks, 3 months, 6 months, 9 months and 12 months
4. Complications, including mortality, avascular necrosis, non-union, implant breakage or failure, and infection (i.e., superficial and deep). Measured post-operatively at 1 week, 2 weeks, 3 months, 6 months, 9 months and 12 months.

Overall trial start date

01/06/2008

Overall trial end date

01/01/2010

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 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 two 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 optimalisation for operative fixation of the hip
8. Provision of informed consent by patient or legal guardian
9. No other major trauma
10. Low energy fracture (defined as a fall from standing height)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

80

Participant 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 except osteoporosis (i.e., Paget's disease, renal osteodystrophy, osteomalacia)
6. Moderate or severe cognitively impaired patients (i.e., Mini-Mental State Examination (MMSE) 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 (i.e., patients with no fixed address, report a plan to move out of town, or intellectually challenged patients without adequate family support)

Recruitment start date

01/06/2008

Recruitment end date

01/01/2010

Locations

Countries of recruitment

Canada

Trial participating centre

McMaster University
Hamilton, Ontario
L8L 8E7
Canada

Sponsor information

Organisation

McMaster University (Canada)

Sponsor details

1200 Main Street West
Hamilton
Ontario
L8N 3Z5
Canada

Sponsor type

University/education

Website

http://www.mcmaster.ca/

Funders

Funder type

Research organisation

Funder name

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-87771)

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