Clinical trial NCT01380444: Intramedullary Nail Versus Sliding Hip Screw Inter-Trochanteric Evaluation
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
Overall status: COMPLETED
Phase: NA
Conditions: Femoral Neck Fractures
Intertrochanteric Fracture
Keywords: Intertrochanteric fracture
Gamma3 intramedullary nail
Sliding hip screw
Lead sponsor: Stryker Trauma and Extremities
Sponsor class: INDUSTRY
Collaborators: name: Global Research Solutions
First posted: 2011-06-27
Enrollment: 880
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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).

Primary outcomes:
measure: Health Related Quality of Life
timeFrame: Up to 104 weeks
Secondary outcomes:
measure: Health Related Quality of Life
timeFrame: Up to 104 weeks
measure: Fracture healing rates
timeFrame: Up to 104 weeks
measure: Fracture-related adverse events
timeFrame: Up to 104 weeks
measure: Revision surgery rates
timeFrame: Up to 104 weeks
Other outcomes:
Locations:
city: Fresno
country: United States
facility: Community Regional Medical Center
state: California
city: San Francisco
country: United States
facility: San Francisco General Hospital
state: California
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Burlington
country: United States
facility: Lahey Clinic
state: Massachusetts
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
city: Temple
country: United States
facility: Scott&White Memorial Hospital
state: Texas
city: Falls Church
country: United States
facility: Inova Fairfax Hospital
state: Virginia
city: Parkville
country: Australia
facility: The Royal Melbourne Hospital
state: Victoria
city: Winnipeg
country: Canada
facility: Health Sciences Centre Winnipeg
state: Manitoba
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Beijing
country: China
facility: Chaoyang Hospital
state: Beijing
city: Shanghai
country: China
facility: Sixth People's Hospital
state: Shanghai
city: Hangzhou
country: China
facility: 2nd Affiliated Hospital of Zhejiang University
state: Zhejiang
city: Medellin
country: Colombia
facility: Clinica El Rosario Sede El Tesoro
state: Antioquia
city: Bogotá
country: Colombia
facility: Hospital Universitario Santa Clara
state: Cundinamarca
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein, Campus Lübeck
city: Stuttgart
country: Germany
facility: Robert-Bosch-Krankenhaus
city: Tsukuba City
country: Japan
facility: Tsukuba Medical Center
state: Ibaraki
city: Amsterdam
country: Netherlands
facility: Onze Lieve Vrouwe Gasthuis
city: Alesund
country: Norway
facility: Helse Sunnmore Alesund Sjukehus
city: Parktown
country: South Africa
facility: Charlotte Maxeke Johannesburg Academic Hospital
city: Bristol
country: United Kingdom
facility: Frenchay Hospital
city: Liverpool
country: United Kingdom
facility: The Royal Liverpool University Hospital
city: Reading
country: United Kingdom
facility: The Royal Berkshire Hospital
city: Southampton
country: United Kingdom
facility: Southampton General Hospital
Study officials:
affiliation: Global Research Solutions
name: Mohit Bhandari, MD, PhD, FRCSC
role: PRINCIPAL_INVESTIGATOR
affiliation: Stryker Trauma and Extremities
name: Georgia Mitchell
role: STUDY_DIRECTOR
References:
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.
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.
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.