Intramedullary Nail Versus Sliding Hip Screw Inter-Trochanteric Evaluation (INSITE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Stryker Trauma GmbH
Sponsor:
Collaborators:
Stryker Osteosynthesis
Global Research Solutions
Information provided by (Responsible Party):
Stryker Trauma GmbH
ClinicalTrials.gov Identifier:
NCT01380444
First received: June 20, 2011
Last updated: July 14, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Femoral Neck Fractures
Intertrochanteric Fracture
Procedure: Gamma3 Intramedullary Nails (Stryker)
Procedure: Sliding Hip Screws

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multi-Center Randomized Controlled Trial of Intramedullary Nails Versus Sliding Hip Screws in the Management of Intertrochanteric Fractures of the Hip

Resource links provided by NLM:


Further study details as provided by Stryker Trauma GmbH:

Primary Outcome Measures:
  • Health Related Quality of Life [ Time Frame: Up to 104 weeks ] [ Designated as safety issue: No ]
    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:
  • Health Related Quality of Life [ Time Frame: Up to 104 weeks ] [ Designated as safety issue: No ]
    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.

  • Fracture healing rates [ Time Frame: Up to 104 weeks ] [ Designated as safety issue: Yes ]
    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.

  • Fracture-related adverse events [ Time Frame: Up to 104 weeks ] [ Designated as safety issue: Yes ]
    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).

  • Revision surgery rates [ Time Frame: Up to 104 weeks ] [ Designated as safety issue: Yes ]
    Any unplanned surgery after the initial fixation to promote fracture healing (non-union), relieve pain (avascular necrosis, early or late implant failure), treat infection, or improve function will be considered a study event.


Estimated Enrollment: 736
Study Start Date: December 2011
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Gamma3 Intramedullary Nails
Procedure: Gamma3 Intramedullary Nails (Stryker)
The Gamma3 nail is cannulated for Guide-Wire-controlled insertion, and features a conical tip for optimal alignment with the inner part of the cortical bone. A single distal Locking Screw is provided to stabilize the nail in the medullary canal and to help to prevent rotation in complex fractures.
Other Names:
  • Gamma Nail
  • Gamma3 Nail
  • Intramedullary Nail (IM Nail)
Active Comparator: 2
Sliding Hip Screws
Procedure: Sliding Hip Screws
The sliding hip screw is a single larger diameter partially threaded screw, which is affixed to the proximal femur with a side plate (with a minimum of two holes and a maximum of four holes) and no supplemental fixation.
Other Names:
  • Sliding Hip Screw (SHS)
  • Dynamic Hip Screw (DHS)
  • Compression Screw and Side Plate

Detailed Description:

Hip fractures are becoming a more prevalent issue worldwide, leading to profound morbidity, and in some cases, mortality. Currently the most common method of surgical treatment includes the use of a sliding hip screw over a Gamma intramedullary nail, but there is conflicting evidence regarding which device has a lower revision surgery rate and complication rate. Recent improvements in implant design of the Gamma3 nail, demonstrating decreased rates of femoral shaft fractures and improved function, provide compelling rationale for the conduct of a large, definitive trial.

This trial is a definitive, multi-center, concealed randomized controlled trial. Surgeons will use one of the two surgical strategies in patients who have sustained a trochanteric fracture; the Gamma3 intramedullary nail or the sliding hip screw. Clinical assessments will occur at the time of hospital admission, post-surgery, 13 weeks, 26 weeks, 52 weeks, and 104 weeks.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01380444

Contacts
Contact: Alisha Hak, BSc. 289-337-0857 alisha.hak@cogeco.net

  Show 26 Study Locations
Sponsors and Collaborators
Stryker Trauma GmbH
Stryker Osteosynthesis
Global Research Solutions
Investigators
Principal Investigator: Mohit Bhandari, MD, PhD, FRCSC Global Research Solutions
Study Director: Georgia Mitchell Stryker Trauma GmbH
  More Information

Publications:
Responsible Party: Stryker Trauma GmbH
ClinicalTrials.gov Identifier: NCT01380444     History of Changes
Other Study ID Numbers: 14032012_INSITE_v2.0, 96308751
Study First Received: June 20, 2011
Last Updated: July 14, 2014
Health Authority: Canada: Ethics Review Committee
Canada: INSITE Steering Committee

Keywords provided by Stryker Trauma GmbH:
Intertrochanteric fracture
Gamma3 intramedullary nail
Sliding hip screw

Additional relevant MeSH terms:
Femoral Neck Fractures
Fractures, Bone
Hip Fractures
Femoral Fractures
Wounds and Injuries
Leg Injuries
Hip Injuries

ClinicalTrials.gov processed this record on August 18, 2014