Clinical trial NCT00555945: Re-Evaluation of GAmma3 Intramedullary Nails in Hip Fracture (REGAIN)
Official title: Re-Evaluation of GAmma3 Intramedullary Nails in Hip Fracture: A Multi-Centre Randomized Controlled Trial of Gamma3 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: Stryker Osteosynthesis
name: Global Research Solutions
First posted: 2007-11-09
Enrollment: 90
Sex: ALL
Minimum age (years): 50
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 rate of revision surgery in individuals with inter-trochanteric fractures. Secondary outcomes include fracture healing rates, fracture related complications, and health-related quality of life.

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 of surgery rate and complication rate. The newest generation of Gamma3 nails have strong rationale suggesting significantly decreased rates of femoral shaft fractures and improved function. The improvements in implant design of the Gamma3 nail provide compelling rationale for the conduct of a large, definitive trial, and therefore a pilot study is being conducted to confirm or refute our ability to recruit patients and assess the consistency between site estimates and actual recruitment, determine the degree to which site investigators can adhere to trial protocol, confirm or refute our anticipated ability to achieve close to 100% follow- up, assess our ability to maintain 100% data quality, field test our case report forms for clarity and appropriateness, and to determine whether we can successfully manage the logistics of coordinating trial activities across multiple sites.

This trial is a pilot, 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, 1 week, 3 months, 6 months, and 12 months after surgery.

Eligibility criteria: Inclusion Criteria:

* Adult men or women aged 50 years and older (with no upper age limit).
* An trochanteric fracture (stable or unstable) confirmed with anterior and posterior lateral hip radiographs, computed tomography, or magnetic resonance imaging (MRI).
* Operative treatment within 3 days (i.e., 72 hours) after the 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.
* Provision of informed consent by patient or proxy.
* Low energy fracture (defined as a fall from standing height).
* No other major trauma.

Exclusion Criteria:

* Associated major injuries of the lower extremity (i.e., ipsilateral or contralateral fractures of the foot, ankle, tibia, fibula, knee, or femur; dislocations of the ankle, knee, or hip; or femoral head defects or fracture).
* Retained hardware around the affected hip.
* Infection around the hip (i.e., soft tissue or bone).
* Patients with disorders of bone metabolism other than osteoporosis (i.e., Paget's disease, renal osteodystrophy, or osteomalacia).
* Moderate or severe cognitively impaired patients (i.e., Six Item Screener with three or more errors).
* Patients with Parkinson's disease (or dementia) severe enough to increase the likelihood of falling or severe enough to compromise rehabilitation.
* Likely problems, in the judgment of the 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.
* If the attending surgeon believes that a patient should be excluded from REGAIN because the 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 REGAIN. This reason will be documented on the case report forms.

Primary outcomes:
measure: Rates of revision surgery
timeFrame: 1 year
Secondary outcomes:
measure: Health Related Quality of Life
timeFrame: Up to12 months
measure: Fracture healing rates
timeFrame: Up to12 months
measure: Complications
timeFrame: Up to12 months
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Hamilton General Hospital
state: Ontario
city: Hamilton
country: Canada
facility: St. Joseph's Hospital
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
Study officials:
affiliation: McMaster University
name: Mohit Bhandari, MD FRCSC MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Parker MJ, Pryor GA. Gamma versus DHS nailing for extracapsular femoral fractures. Meta-analysis of ten randomised trials. Int Orthop. 1996;20(3):163-8. doi: 10.1007/s002640050055.
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: Harrington P, Nihal A, Singhania AK, Howell FR. Intramedullary hip screw versus sliding hip screw for unstable intertrochanteric femoral fractures in the elderly. Injury. 2002 Jan;33(1):23-8. doi: 10.1016/s0020-1383(01)00106-1.