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Trial registered on ANZCTR


Trial ID
ACTRN12612000520831
Ethics application status
Approved
Date submitted
14/05/2012
Date registered
16/05/2012
Date last updated
30/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The impact of intramedullary (in the bone) nails versus sliding hip screws on health-related quality of life in patients with hip fracture
Scientific title
Intramedullary Nail Versus Sliding Hip Screw Inter-Trochanteric Evaluation (INSITE):
A multi-centre randomized controlled trial to assess the impact of intramedullary nails versus sliding hip screws on health-related quality of life in patients with intertrochanteric fractures of the hip
Secondary ID [1] 280483 0
Clinicaltrials.gov Identifier - NCT01380444
Secondary ID [2] 280487 0
International Standard Randomised Controlled Trial Number Register: ISRCTN96308751
Secondary ID [3] 280488 0
German Clinical Trials Register DRKS-ID: DRKS00003342
Universal Trial Number (UTN)
U1111-1130-7348
Trial acronym
INSITE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Intertrochanteric Hip Fractures 286463 0
Condition category
Condition code
Injuries and Accidents 286720 286720 0 0
Fractures

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The interventional treatment used in the study is an intramedullary nail. The implant is a short, interlocking intramedullary device that consists of a sliding lag screw, which passes through a short intramedullary nail. The duration of the implant procedure is approximately 1 hour. The implant is intended to remain in place permanently.
Intervention code [1] 284850 0
Treatment: Devices
Intervention code [2] 284856 0
Treatment: Surgery
Comparator / control treatment
The comparator treatment used in the study is a sliding hip screw. The screw consists of a lag screw passed up the femoral neck to the femoral head. This lag screw is then attached to a plate on the side of the femur. The duration of the implant procedure is approximately 1 hour. The implant is intended to remain in place permanently.
Control group
Active

Outcomes
Primary outcome [1] 287118 0
Health-related Quality of Life
Timepoint [1] 287118 0
Measured using EuroQol-5D pre-operatively, then at 13, 26 and 52 weeks post-operatively.
Secondary outcome [1] 297420 0
Health-related Quality of Life
Timepoint [1] 297420 0
Measure using Harris Hip Score and Parker Mobility Score pre-operatively, then at 13, 26 and 52 weeks post-operatively.
Secondary outcome [2] 297421 0
Fracture healing rates
Timepoint [2] 297421 0
Measured using X-rays at 13 weeks and 52 weeks post-operatively.
Secondary outcome [3] 297422 0
Fracture-related adverse events, for example failure of bone to repair, pain at site of hip fracture, fall caused by inability to use hip properly. These types of events will be assessed by patient reporting and analysis of X-rays.
Timepoint [3] 297422 0
Measure up to 52 weeks post-operatively
Secondary outcome [4] 297423 0
Revision surgery rates
Timepoint [4] 297423 0
Measured up to 52 weeks post-operatively

Eligibility
Key inclusion criteria
1.Adult men or women aged 18 years and older (with no upper age limit).
2.An intertrochanteric fracture (stable or unstable), AO Type 31-A1 or 31-A2, confirmed with anteroposterior and lateral hip radiographs, computed tomography, or magnetic resonance imaging (MRI).
3.Low energy fracture (defined as a fall from standing height).
4.No other major trauma.
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 of the patient for operative fixation of the proximal femur.
7.Operative treatment within 7 days after the trauma.(Operative treatment should take place as soon as possible as permitted by each institution's standard of care.)
8.Provision of informed consent by patient or proxy.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1.Associated major injuries of the lower extremity (i.e., ipsilateral and/or contralateral fractures of the foot, ankle, tibia, fibula, or knee; dislocations of the ankle, knee, or hip).
2.Retained hardware around the affected proximal femur.
3.Infection around the proximal femur (i.e., soft tissue or bone).
4.Patients with disorders of bone metabolism other than osteoporosis (i.e., Paget's disease, renal osteodystrophy, or osteomalacia).
5.Patients with Parkinson's disease severe enough to increase the likelihood of falling or severe enough to compromise rehabilitation.
6.Patients with a subtrochanteric fracture.
7.Patients with a pathologic fracture.
8.Patients with a reverse oblique fracture pattern, fracture AO Type 31-A3.
9.Obesity in the judgment of the attending surgeon.
10.Off-label use of the implant.
11.Patients with a previous history of frank dementia that would interfere with assessment of the primary outcome (i.e., EQ-5D at 1 year).
12.Likely problems, in the judgment of the Site 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.
13.Patient is enrolled in another ongoing drug or surgical intervention trial.
14.If the attending surgeon believes that there is another reason to exclude this patient from INSITE. This reason will be documented on the case report forms (CRFs).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All patients presenting to participating surgeons with a diagnosed trochanteric fracture
amenable to internal fixation will be screened. Such patients will be classified as:
1. Excluded (if they subsequently do not meet the eligibility criteria).
2. Missed (due to error).
3. Eligible and randomized (if applicable).
It is pertinent that all patients screened (including those who were missed or excluded) be
entered into the SmartManager Electronic Data Capture (EDC) System or reported to GRS.
The Clinical Site may enter an electronic Screening Form in the SmartManager EDC System for
each of these subjects, indicating that the subject has been missed or excluded. The Clinical
Site may also fax the paper Screening Form directly to GRS, or the monitor will work with the
Clinical Site to develop a method of regularly reporting this information via some mutually
agreeable reporting method.
If the participating Site Investigator identifies an eligible patient who consents to randomization,
the Site Investigator or delegate will use the online randomization system to randomize the
subject into one of two treatment arms. The Research Coordinator, or Site Investigator will
enter their unique subject prognostic variables for stratification. This procedure guarantees
concealed randomization.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
We will conceal allocation using a centralized 24-hour digital Internet randomization system
(EmPOWER Inc). To protect against prognostic imbalance between groups; we will use stratification
to ensure balance between intervention groups for several subject factors. We will stratify by the
following prognostic factors: 1) participating center; 2) fracture stability (stable versus unstable); and
3) age (18-50 years versus >50 years).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
No data analysis planned
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 375 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment postcode(s) [1] 5290 0
3050
Recruitment outside Australia
Country [1] 4302 0
United States of America
State/province [1] 4302 0
Massachusetts
Country [2] 4303 0
Canada
State/province [2] 4303 0
Manitoba
Country [3] 4304 0
China
State/province [3] 4304 0
Beijing
Country [4] 4305 0
South Africa
State/province [4] 4305 0
Johannesburg
Country [5] 4306 0
Norway
State/province [5] 4306 0
Alesund
Country [6] 4307 0
Germany
State/province [6] 4307 0
Stuttgart
Country [7] 4308 0
Germany
State/province [7] 4308 0
Lubeck
Country [8] 4309 0
Denmark
State/province [8] 4309 0
Aarhus
Country [9] 4310 0
Colombia
State/province [9] 4310 0
Antioquia
Country [10] 4311 0
China
State/province [10] 4311 0
Zhejiang
Country [11] 4312 0
Canada
State/province [11] 4312 0
Ontario
Country [12] 4313 0
United States of America
State/province [12] 4313 0
West Virginia
Country [13] 4314 0
United States of America
State/province [13] 4314 0
Virginia
Country [14] 4315 0
United States of America
State/province [14] 4315 0
Texas
Country [15] 4316 0
United States of America
State/province [15] 4316 0
Pennsylvania
Country [16] 4317 0
Colombia
State/province [16] 4317 0
Cundinamarca

Funding & Sponsors
Funding source category [1] 285241 0
Commercial sector/Industry
Name [1] 285241 0
Stryker Australia Pty Ltd
Address [1] 285241 0
8 Herbert St
St Leonards NSW 2065
Country [1] 285241 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Stryker Australia Ptd Ltd
Address
8 Herbert St
St Leonards NSW 2065
Country
Australia
Secondary sponsor category [1] 284106 0
None
Name [1] 284106 0
Address [1] 284106 0
Country [1] 284106 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287249 0
Melbourne Health Human Research Ethics Committee
Ethics committee address [1] 287249 0
The Royal Melbourne Hospital
Grattan Street
Parkville
VIC 3050
Ethics committee country [1] 287249 0
Australia
Date submitted for ethics approval [1] 287249 0
30/05/2012
Approval date [1] 287249 0
21/09/2012
Ethics approval number [1] 287249 0

Summary
Brief summary
The purpose of this study is to assess the impact of Gamma3 intramedullary nails versus sliding hip screws on health-related quality of life as measured by the EuroQuol-5D at 52 weeks in individuals with trochanteric fractures. Secondary outcomes include revision surgery rates, fracture healing rates, fracture related adverse events, and health-related quality of life, including the Parker mobility score and Harris Hip Score.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34174 0
A/Prof Andrew Bucknill
Address 34174 0
Level 7 Orthopaedics
Royal Melbourne Hospital
Grattan Street Parkville VIC 3050
Country 34174 0
Australia
Phone 34174 0
+61 3 9342 8479
Fax 34174 0
+61 3 9342 8780
Email 34174 0
andrew.bucknill@mh.org.au
Contact person for public queries
Name 17421 0
Miss Nicola Burridge
Address 17421 0
8 Herbert Street
St Leonards
NSW 2065
Country 17421 0
Australia
Phone 17421 0
+61 2 9467 1049
Fax 17421 0
+61 2 9467 1132
Email 17421 0
nicola.burridge@stryker.com
Contact person for scientific queries
Name 8349 0
Miss Nicola Burridge
Address 8349 0
8 Herbert Street
St Leonards
NSW 2065
Country 8349 0
Australia
Phone 8349 0
+61 2 9467 1049
Fax 8349 0
+61 2 9467 1132
Email 8349 0
nicola.burridge@stryker.com