| CTRI Number |
CTRI/2011/09/001986 [Registered on: 06/09/2011] Trial Registered Prospectively |
| Last Modified On: |
20/11/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Fixation using Alternative Implants for the
Treatment of Hip Fractures
|
|
Scientific Title of Study
|
Fixation using Alternative Implants for the Treatment of Hip Fracture (FAITH):A Multi-Centre Randomized Trial Comparing Sliding Hip Screws and Cancellous Screws on Revision Surgery Rates and Quality of Life in the Treatment of Femoral Neck Fractures |
| Trial Acronym |
FAITH |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NCT00557167 |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Hrishikesh |
| Designation |
Project Manager |
| Affiliation |
iProcess- Scientist |
| Address |
S3,2ND FLR, EBONY 7/1 EAGLE ST CROSS, LANGFORD TOWN
Bangalore
KARNATAKA
560025
India |
| Phone |
|
| Fax |
|
| Email |
hrishi@iprocess.net |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hrishikesh |
| Designation |
Project Manager |
| Affiliation |
iProcess- Scientist |
| Address |
S3,2ND FLR, EBONY 7/1 EAGLE ST CROSS, LANGFORD TOWN
Bangalore
KARNATAKA
560025
India |
| Phone |
|
| Fax |
|
| Email |
hrishi@iprocess.net |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hrishikesh |
| Designation |
Project Manager |
| Affiliation |
iProcess- Scientist |
| Address |
S3,2ND FLR, EBONY 7/1 EAGLE ST CROSS, LANGFORD TOWN
Bangalore
KARNATAKA
560025
India |
| Phone |
|
| Fax |
|
| Email |
hrishi@iprocess.net |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
McMaster University |
| Address |
McMaster University
293 Wellington Street North, Suite 110
Ontario, CANADA
L8L 8E7 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Australia
Canada
Netherlands
Norway
United States of America |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr D C Sundaresh |
M.S. Ramaiah Medical College & Hospital |
Sr Prof, Dept of Orthopedic
MSRIT POST,MSR NAGAR, BANGALORE 560054
Bangalore
KARNATAKA |
08023609999
msrortho@hotmail.com |
| Dr Amul Shankar Prasad |
Madhuraj Nursing Home |
Department of Orthopedics
113/121-A, SWAROOP NAGAR, KANPUR-208002
Kanpur Nagar
UTTAR PRADESH |
0512-23042077
drprasadas@gmail.com |
| DrB Sachidananda Rai |
Unity Hospital |
Department of Orthopedics
P.B No.535, Highlands, Mangalore 575002
Uttara Kannada
KARNATAKA |
9448455166
bsrai111@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| M.S Ramaiah Medical College and Teaching Hospital |
Approved |
| Madhuraj Nursing Home |
Approved |
| Unity Health Complex |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Hip Fractures
Femoral Neck Fractures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Multiple cancellous screws fixation |
Patients allocated to multiple cancellous screws fixation will receive multiple threaded screws (with a minimum of 2 screws, a minimum diameter of 6.5 mm). Surgeons will be allowed to use any threaded screw or hook pin (i.e., Gouffon, Uppsala, von Bahr, Hansson hook pins, etc.) or cancellous threaded screw |
| Comparator Agent |
Sliding hip screw |
Patients allocated to sliding hip screw fixation will receive a single larger diameter partially threaded screw affixed to the proximal femur with a sideplate (with a minimum of 2 holes and a maximum of 4 holes) and no supplemental fixations. Surgeons will be permitted to use any commercially available sliding hip screw implant (i.e., Stryker, DePuy, Synthes, Smith and Nephew, Zimmer, etc.), and will insert implants as per the manufacturers technical guides. |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Adult men or women aged 50 years and older (with no upper age limit).
Fracture of the femoral neck confirmed with either anteroposterior and lateral hip radiographs, computed tomography, or magnetic resonance imaging (MRI).
Any degree of displacement (i.e., undisplaced or displaced) of the femoral neck fracture that can be closed reduced.
Operative treatment of displaced fractures within 2 days (i.e., 48 hours) of presenting to the emergency room.
Operative treatment of undisplaced fractures within 7 days of presenting to the emergency room.
Patient was ambulatory prior to fracture, though they may have used an aid such as a cane or a walker.
Anticipated medical optimalization for operative fixation of the hip.
Provision of informed consent by patient or legal guardian.
Low energy fracture (defined as a fall from standing height).
No other major trauma
|
|
| ExclusionCriteria |
| Details |
Patients not suitable for internal fixation (i.e., severe osteoarthritis, rheumatoid arthritis, or pathologic fracture).
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).
Retained hardware around the affected hip.
Infection around the hip (i.e., soft tissue or bone).
Patients with disorders of bone metabolism except osteoporosis (i.e., Pagets disease, renal osteodystrophy, osteomalacia).
Moderate or severe cognitively impaired patients (i.e., Six Item Screener with 3 or more errors).
Patients with Parkinsons disease (or dementia) severe enough to increase the likelihood of falling or severe enough to compromise rehabilitation.
Likely problems, in the judgment of the investigators, with maintaining follow-up. We will, for example, exclude patients with no fixed address, those who report a plan to move out of town in the next year, or intellectually challenged patients without adequate family support
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the impact of sliding hip screws versus cancellous screw fixation on rates of revision surgery at 2 years in individuals with femoral neck fractures |
To assess the impact of sliding hip screws versus cancellous screw fixation on rates of revision surgery at 2 years in individuals with femoral neck fractures |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine the impact on health-related quality of life,functional outcomes and health outcome |
2 years |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="25"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
07/11/2011 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
01/01/2008 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="5"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Hip fractures occur in 280,000 Americans (over 5,000 per week) and 36,000 (over 690 per week) Canadians annually. The number of hip fractures is likely to exceed 500,000 annually in the United States and 88,000 in Canada. The estimated annual health care costs will reach a staggering $9.8 billion in the United States and $650 million in Canada. Hip fractures are associated with a 30% mortality rate and profound temporary and sometimes permanent impairment of independence and quality of life. Worldwide, 4.5 million persons are disabled from hip fractures yearly with an expected increase to 21 million persons living with disability in the next 40 years. Experimental data suggest that cancellous screws offer greater preservation of blood supply, while sliding hip screws provide greater biomechanical stability to bending stresses. While both arguments are persuasive, the impacts of these biologic alterations on outcomes that are important to patients offer more compelling guidance for clinical practice.
Although current opinion among orthopaedic surgeons favour the use of cancellous screws over sliding hip screws, there remains sufficient divergence in perceptions and sufficient interest to resolve this issue to warrant a large randomized controlled trial. Despite the popularity of cancellous screw fixation, there is a strong biologic rationale supporting the sliding hip screws, a more biomechanically stable construct, in older patients with osteopenia or osteoporosis. While our meta-analysis provides indirect and direct evidence that a sliding hip screw may reduce revision surgery rates, the evidence remains far from definitive. The current best estimate of treatment effect with sliding hip screws is based upon small trials with methodological limitations including unconcealed randomization and lack of blinding. The resulting estimates include wide confidence intervals (i.e., displaced fractures: RRR=27%, 95%CI: 48%, -4%, P=0.08). Whatever approach to internal fixation proves best, a large proportion of patients will continue to need revision surgery that is associated with high morbidity and appreciable mortality |