Re-Evaluation of GAmma3 Intramedullary Nails in Hip Fracture (REGAIN)

Stryker Trauma and Extremities

Status

Completed

Conditions

Femoral Neck Fractures

Intertrochanteric Fracture

Treatments

Procedure: Gamma3 intramedullary nail (Stryker)

Procedure: Sliding Hip Screw

Study type

Interventional

Funder types

Industry

Other

Identifiers

NCT00555945

06042011_REGAIN_v1.0

Details and patient eligibility

About

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.

Full 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.

Enrollment

90 patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

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.