Condition category
Injury, Occupational Diseases, Poisoning
Date applied
31/08/2011
Date assigned
18/10/2011
Last edited
18/07/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Intertrochanteric fractures are a common fracture of the hip. The hip joint connects the thighbone (femur) with the pelvis. Despite the name 'hip fracture', the break is actually below the hip joint, near the upper end of the thighbone. Following a fall, severe pain occurs in the area of the hip, groin and thigh. It is usually impossible to get up or walk. Very occasionally when the bone is cracked rather than completely broken, walking is possible although painful. Intertrochanteric fractures are commonly treated with internal fixation. With internal fixation, the fracture is repaired with metal screws or plates. The two common methods of internal fixation are Gamma intramedullary nails and sliding hip screws. It is unknown whether Gamma intramedullary nails have better results than sliding hip screws. The purpose of this study is to investigate whether Gamma3 intramedullary nails versus sliding hip screws will improve quality of life in patients with intertrochanteric fractures (hip fractures). We will also compare functional recovery, complications, fracture healing, and rates of revision surgeries between the two treatment groups.

Who can participate?
Our study will include 736 patients from medical centres located in Canada, the USA, Europe, and other international sites. We will enrol both male and female patients who are 18 years and older and who present an intertrochanteric fracture. Healthy volunteers will not be included

What does the study involve?
Patients will be assigned at random, that is, by a method of chance (like a flip of a coin), to one of two groups. There is a 1 in 2 chance (or a 50% chance) of being in the Gamma3 intramedullary nail group. There is a 1 in 2 chance (or a 50% chance) of being in the group that receives the sliding hip screw.

What are the possible benefits and risks of participating?
As with any surgical procedure of the lower extremity, potential risks include: femoral shaft (thigh bone) fractures, wound and deep infection, pulmonary embolism (a blood clot in the lung)/deep vein thrombosis (a blood clot in the leg), neurovascular injury (injury to nerves and blood vessels), compartment syndrome (increased pressure in muscles), nonunion (fracture does not heal), malunion (fracture heals incorrectly), and death. We cannot promise any personal benefits to patients participating in this study. The results of this study may help other people with hip fractures in the future.

Where is the study run from?
Global Research Solutions (GRS) is based in Hamilton, ON, Canada. There will be up to 50 sites worldwide, with 20 sites across the USA and Canada, another 20 sites in Europe, and 10 sites in countries around the world.
In the UK the leading site will be Frenchay Hospital, Frenchay Park Road, Bristol BS16 1LE.

When is the study starting and how long is it expected to run for?
The study is expected to start in September 2011 and to end in September 2015.

Who is funding the study?
The study is funded by Stryker Osteosynthesis (Germany).

Who is the main contact?
Dr Mohit Bhandari
mohit.bhandari@cogeco.net

Trial website

Contact information

Type

Scientific

Primary contact

Dr Mohit Bhandari

ORCID ID

Contact details

Global Research Solutions
Suite 206
3228 South Service Road
Ontario
Burlington
L7N 3H8
Canada

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT01380444

Protocol/serial number

14032012_INSITE_v2.0

Study information

Scientific title

Intramedullary Nail versus Sliding hip screw Inter-Trochanteric Evaluation (INSITE): a multicenter randomized controlled trial

Acronym

INSITE

Study hypothesis

Among individuals 18 years and older with trochanteric fractures, what is the impact of Gamma3 Intramedullary Nails versus Sliding Hip Screws on health-related quality of life as measured by the EuroQol-5D?

On 05/01/2012 the following changes were made to the trial record:
1. The anticipated start date was changed from 01/09/2011 to 19/12/2011.
2. The anticipated end date was changed from 30/09/2015 to 31/12/2015.

On 07/05/2013 Spain and Sweden were removed from the countries of recruitment.

On 18/07/2014 the anticipated end date was changed from 31/12/2015 to 01/03/2017.

Ethics approval

Institutional Review Board Services, Canada, 17/08/2011

Study design

Definitive multicenter concealed randomized controlled trial

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

Trochanteric fracture

Intervention

Either Gamma3 intramedullary nail or Sliding/Dynamic Hip Screw [SHS / DHS] - depending on allocation by randomization system.

Patients allocated to the Gamma3 Intramedullary Nail treatment group will receive a Gamma3 intramedullary (Stryker) nail through a closed technique. Surgeons will follow the technique guides associated with the Gamma3 intramedullary nail manufacturer (Gamma3 Trochanteric Nail 180, B0300008, LOT G0710, Stryker 2010. and Gamma3 Trochanteric Long Nail, B0300009, LOT D3207, Stryker 2004). Augmentation of the implant fixation will be permitted and documented. Any type of navigation system and other add-on cleared products (CAS, Gamma 3 inside out) will be as well permitted and documented.

Patients allocated to the Sliding Hip Screw treatment group will receive a single larger diameter partially threaded screw affixed to the proximal femur with a side plate that has four 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, Hansson, etc.), and will insert implants as per the manufacturersÂ’ technical guidelines. Kirschner wires should be used at the discretion of the operating surgeon. It is recommended that antirotational kirschner wires are used for lateral (basocervical) femoral head fractures. We recommend a center-to-center approach, while avoiding a superior and anterior approach. The use of a compression screw, manufacturer, reduction technique, the type of lag screw, if spiral blades and helical screws were used, and final screw position will be documented and based upon surgeon preference. The use of spiral blades and helical screws are protocol deviations, and justification for their use must be provided. Augmentation of the implant fixation will be permitted and documented.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

To assess the impact of Gamma3 intramedullary nails versus sliding hip screws on health-related quality of life as measured by the EuroQol-5D at 52 weeks in individuals with trochanteric fractures

Secondary outcome measures

1. Health-related quality of life at up to 104 weeks
2. To assess the impact of Gamma3 intramedullary nails versus sliding hip screws on health-related quality of life as measured with the Parker mobility score and the Harris Hip Score
3. Fracture healing rates at up to 104 weeks. A fracture is to be considered healed when there is obliteration of the fracture lines by newly formed bone along the cortices and within the trabecular bone on anteroposterior and lateral (or oblique) radiographs
4. Fracture-related adverse events at up to 104 weeks, including mortality, femoral shaft fracture, avascular necrosis (although rare in trochanteric fractures), nonunion, malunion (shortening, varus deformity, valgus deformity and rotational malunion), implant breakage or failure, and infection (i.e. superficial and deep)
5. Revision surgery rates at up to 104 weeks. Any unplanned surgery after the initial fixation to promote fracture healing (nonunion), relieve pain (avascular necrosis, early or late implant failure), treat infection, or improve function will be considered a study event

Overall trial start date

19/12/2011

Overall trial end date

01/03/2017

Reason abandoned

Eligibility

Participant inclusion criteria

Current inclusion criteria as of 05/04/2012:
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

Previous inclusion criteria:
1. Adult men or women aged 18 years and older (with no upper age limit)
2. A trochanteric fracture (stable or unstable) 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

736 (368 in each treatment arm)

Participant exclusion criteria

Current exclusion criteria as of 05/04/2012:
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

Previous 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
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 investigators, with maintaining followup. E.g. 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

Recruitment start date

19/12/2011

Recruitment end date

01/03/2017

Locations

Countries of recruitment

Australia, Brazil, Canada, China, Colombia, Denmark, Germany, Netherlands, South Africa, United Kingdom, United States of America

Trial participating centre

Global Research Solutions,
Burlington
L7N 3H8
Canada

Sponsor information

Organisation

Stryker Trauma GmbH (Germany)

Sponsor details

c/o Prof Kuentscher
Str. 1-5
Schoenkirchen
24232
Germany
+1 732 966 2910
georgia.mitchell@stryker.com

Sponsor type

Industry

Website

http://www.stryker.com

Funders

Funder type

Research organisation

Funder name

Global Research Solutions (Germany)

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