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

A Multi-Center Randomized Controlled Trial of Intramedullary Nails Versus Sliding Hip Screws in the Management of Intertrochanteric Fractures of the Hip

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.

Study Overview

• Status: Completed
• Conditions: Femoral Neck Fractures; Intertrochanteric Fracture
• Intervention / Treatment: Procedure: Gamma3 Intramedullary Nails (Stryker); Procedure: Sliding Hip Screws

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.

• Study Type: Interventional
• Enrollment (Actual): 880
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Parkville, Victoria, Australia, 3039
      • The Royal Melbourne Hospital
• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3A 1R9
      • Health Sciences Centre Winnipeg
  • Ontario
    • Toronto, Ontario, Canada, M5C 1R6
      • St. Michael's Hospital
• China
  • Beijing
    • Beijing, Beijing, China, 100020
      • Chaoyang Hospital
  • Shanghai
    • Shanghai, Shanghai, China, 200233
      • Sixth People's Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • 2nd Affiliated Hospital of Zhejiang University
• Colombia
  • Antioquia
    • Medellin, Antioquia, Colombia
      • Clinica El Rosario Sede El Tesoro
  • Cundinamarca
    • Bogotá, Cundinamarca, Colombia
      • Hospital Universitario Santa Clara
• Denmark
  • Aarhus, Denmark, 8000
    • Aarhus University Hospital
• Germany
  • Lübeck, Germany, 23538
    • Universitätsklinikum Schleswig-Holstein, Campus Lübeck
  • Stuttgart, Germany, 70376
    • Robert-Bosch-Krankenhaus
• Japan
  • Ibaraki
    • Tsukuba City, Ibaraki, Japan, 305-8558
      • Tsukuba Medical Center
• Netherlands
  • Amsterdam, Netherlands, 1091
    • Onze Lieve Vrouwe Gasthuis
• Norway
  • Alesund, Norway, 6026
    • Helse Sunnmore Alesund Sjukehus
• South Africa
  • Parktown, South Africa, 2193
    • Charlotte Maxeke Johannesburg Academic Hospital
• United Kingdom
  • Bristol, United Kingdom, BS16 1LE
    • Frenchay Hospital
  • Liverpool, United Kingdom, L7 8XP
    • The Royal Liverpool University Hospital
  • Reading, United Kingdom, RG1 5AN
    • The Royal Berkshire Hospital
  • Southampton, United Kingdom, SO16 6YD
    • Southampton General Hospital
• United States
  • California
    • Fresno, California, United States, 93721
      • Community Regional Medical Center
    • San Francisco, California, United States, 94110
      • San Francisco General Hospital
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
    • Burlington, Massachusetts, United States, 01805
      • Lahey Clinic
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19140
      • Temple University Hospital
  • Texas
    • Temple, Texas, United States, 76508
      • Scott&White Memorial Hospital
  • Virginia
    • Falls Church, Virginia, United States, 22042
      • Inova Fairfax Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 104 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 104 weeks
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.	Up to 104 weeks
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).	Up to 104 weeks
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.	Up to 104 weeks

Collaborators and Investigators

• Sponsor: Stryker Trauma GmbH
• Collaborators: Global Research Solutions
• Investigators: Principal Investigator: Mohit Bhandari, MD, PhD, FRCSC, Global Research Solutions; Study Director: Georgia Mitchell, Stryker Trauma GmbH

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2011
• Primary Completion (Actual): March 1, 2017
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: June 20, 2011
• First Submitted That Met QC Criteria: June 22, 2011
• First Posted (Estimate): June 27, 2011

Study Record Updates

• Last Update Posted (Actual): March 7, 2019
• Last Update Submitted That Met QC Criteria: March 5, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Intertrochanteric fracture; Gamma3 intramedullary nail; Sliding hip screw
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Fractures, Bone; Hip Fractures; Femoral Neck Fractures
• Other Study ID Numbers: 14032012_INSITE_v2.0; 96308751 (Registry Identifier: ISRCTN)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• product manufactured in and exported from the U.S.: No