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

Primary Purpose

Femoral Neck Fractures, Intertrochanteric Fracture

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Gamma3 Intramedullary Nails (Stryker)
Sliding Hip Screws
Sponsored by
Stryker Trauma GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Femoral Neck Fractures focused on measuring Intertrochanteric fracture, Gamma3 intramedullary nail, Sliding hip screw

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Community Regional Medical Center
  • San Francisco General Hospital
  • Beth Israel Deaconess Medical Center
  • Lahey Clinic
  • Temple University Hospital
  • Scott&White Memorial Hospital
  • Inova Fairfax Hospital
  • The Royal Melbourne Hospital
  • Health Sciences Centre Winnipeg
  • St. Michael's Hospital
  • Chaoyang Hospital
  • Sixth People's Hospital
  • 2nd Affiliated Hospital of Zhejiang University
  • Clinica El Rosario Sede El Tesoro
  • Hospital Universitario Santa Clara
  • Aarhus University Hospital
  • Universitätsklinikum Schleswig-Holstein, Campus Lübeck
  • Robert-Bosch-Krankenhaus
  • Tsukuba Medical Center
  • Onze Lieve Vrouwe Gasthuis
  • Helse Sunnmore Alesund Sjukehus
  • Charlotte Maxeke Johannesburg Academic Hospital
  • Frenchay Hospital
  • The Royal Liverpool University Hospital
  • The Royal Berkshire Hospital
  • Southampton General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

Gamma3 Intramedullary Nails

Sliding Hip Screws

Outcomes

Primary Outcome Measures

Health Related Quality of Life
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
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
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
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
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.

Full Information

First Posted
June 20, 2011
Last Updated
March 5, 2019
Sponsor
Stryker Trauma GmbH
Collaborators
Global Research Solutions
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1. Study Identification

Unique Protocol Identification Number
NCT01380444
Brief Title
Intramedullary Nail Versus Sliding Hip Screw Inter-Trochanteric Evaluation
Acronym
INSITE
Official Title
A Multi-Center Randomized Controlled Trial of Intramedullary Nails Versus Sliding Hip Screws in the Management of Intertrochanteric Fractures of the Hip
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
December 2011 (Actual)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
March 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stryker Trauma GmbH
Collaborators
Global Research Solutions

4. Oversight

Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Femoral Neck Fractures, Intertrochanteric Fracture
Keywords
Intertrochanteric fracture, Gamma3 intramedullary nail, Sliding hip screw

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
880 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Gamma3 Intramedullary Nails
Arm Title
2
Arm Type
Active Comparator
Arm Description
Sliding Hip Screws
Intervention Type
Procedure
Intervention Name(s)
Gamma3 Intramedullary Nails (Stryker)
Other Intervention Name(s)
Gamma Nail, Gamma3 Nail, Intramedullary Nail (IM Nail)
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Sliding Hip Screws
Other Intervention Name(s)
Sliding Hip Screw (SHS), Dynamic Hip Screw (DHS), Compression Screw and Side Plate
Intervention Description
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.
Primary Outcome Measure Information:
Title
Health Related Quality of Life
Description
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.
Time Frame
Up to 104 weeks
Secondary Outcome Measure Information:
Title
Health Related Quality of Life
Description
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.
Time Frame
Up to 104 weeks
Title
Fracture healing rates
Description
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.
Time Frame
Up to 104 weeks
Title
Fracture-related adverse events
Description
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).
Time Frame
Up to 104 weeks
Title
Revision surgery rates
Description
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.
Time Frame
Up to 104 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult men or women aged 18 years and older (with no upper age limit). 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). Low energy fracture (defined as a fall from standing height). No other major trauma. Patient was ambulatory prior to fracture, though they may have used an aid such as a cane or a walker. Anticipated medical optimization of the patient for operative fixation of the proximal femur. 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.) Provision of informed consent by patient or proxy. Exclusion Criteria: 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). Retained hardware around the affected proximal femur. Infection around the proximal femur (i.e., soft tissue or bone). Patients with disorders of bone metabolism other than osteoporosis (i.e., Paget's disease, renal osteodystrophy, or osteomalacia). Patients with Parkinson's disease severe enough to increase the likelihood of falling or severe enough to compromise rehabilitation. Patients with a subtrochanteric fracture. Patients with a pathologic fracture. Patients with a reverse oblique fracture pattern, fracture AO Type 31-A3. Obesity in the judgment of the attending surgeon. Off-label use of the implant. Patients with a previous history of frank dementia that would interfere with assessment of the primary outcome (i.e., EQ-5D at 1 year). 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. Patient is enrolled in another ongoing drug or surgical intervention trial. 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohit Bhandari, MD, PhD, FRCSC
Organizational Affiliation
Global Research Solutions
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Georgia Mitchell
Organizational Affiliation
Stryker Trauma GmbH
Official's Role
Study Director
Facility Information:
Facility Name
Community Regional Medical Center
City
Fresno
State/Province
California
ZIP/Postal Code
93721
Country
United States
Facility Name
San Francisco General Hospital
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Lahey Clinic
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01805
Country
United States
Facility Name
Temple University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
Scott&White Memorial Hospital
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
Inova Fairfax Hospital
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
Facility Name
The Royal Melbourne Hospital
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3039
Country
Australia
Facility Name
Health Sciences Centre Winnipeg
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A 1R9
Country
Canada
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5C 1R6
Country
Canada
Facility Name
Chaoyang Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100020
Country
China
Facility Name
Sixth People's Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200233
Country
China
Facility Name
2nd Affiliated Hospital of Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
Facility Name
Clinica El Rosario Sede El Tesoro
City
Medellin
State/Province
Antioquia
Country
Colombia
Facility Name
Hospital Universitario Santa Clara
City
Bogotá
State/Province
Cundinamarca
Country
Colombia
Facility Name
Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark
Facility Name
Universitätsklinikum Schleswig-Holstein, Campus Lübeck
City
Lübeck
ZIP/Postal Code
23538
Country
Germany
Facility Name
Robert-Bosch-Krankenhaus
City
Stuttgart
ZIP/Postal Code
70376
Country
Germany
Facility Name
Tsukuba Medical Center
City
Tsukuba City
State/Province
Ibaraki
ZIP/Postal Code
305-8558
Country
Japan
Facility Name
Onze Lieve Vrouwe Gasthuis
City
Amsterdam
ZIP/Postal Code
1091
Country
Netherlands
Facility Name
Helse Sunnmore Alesund Sjukehus
City
Alesund
ZIP/Postal Code
6026
Country
Norway
Facility Name
Charlotte Maxeke Johannesburg Academic Hospital
City
Parktown
ZIP/Postal Code
2193
Country
South Africa
Facility Name
Frenchay Hospital
City
Bristol
ZIP/Postal Code
BS16 1LE
Country
United Kingdom
Facility Name
The Royal Liverpool University Hospital
City
Liverpool
ZIP/Postal Code
L7 8XP
Country
United Kingdom
Facility Name
The Royal Berkshire Hospital
City
Reading
ZIP/Postal Code
RG1 5AN
Country
United Kingdom
Facility Name
Southampton General Hospital
City
Southampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
12151898
Citation
Ahrengart L, Tornkvist H, Fornander P, Thorngren KG, Pasanen L, Wahlstrom P, Honkonen S, Lindgren U. A randomized study of the compression hip screw and Gamma nail in 426 fractures. Clin Orthop Relat Res. 2002 Aug;(401):209-22. doi: 10.1097/00003086-200208000-00024.
Results Reference
background
PubMed Identifier
19550235
Citation
Bhandari M, Schemitsch E, Jonsson A, Zlowodzki M, Haidukewych GJ. Gamma nails revisited: gamma nails versus compression hip screws in the management of intertrochanteric fractures of the hip: a meta-analysis. J Orthop Trauma. 2009 Jul;23(6):460-4. doi: 10.1097/BOT.0b013e318162f67f.
Results Reference
background
PubMed Identifier
18646058
Citation
Parker MJ, Handoll HH. Gamma and other cephalocondylic intramedullary nails versus extramedullary implants for extracapsular hip fractures in adults. Cochrane Database Syst Rev. 2008 Jul 16;(3):CD000093. doi: 10.1002/14651858.CD000093.pub4.
Results Reference
background

Learn more about this trial

Intramedullary Nail Versus Sliding Hip Screw Inter-Trochanteric Evaluation

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