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

NCT ID: NCT00555945

Last Updated: 2011-06-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-05-31
• Study Completion Date: 2009-06-30

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.

Conditions

Femoral Neck Fractures; Intertrochanteric Fracture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

Gamma3 intramedullary nail

Group Type: ACTIVE_COMPARATOR

Gamma3 intramedullary nail (Stryker)

Intervention Type: PROCEDURE

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.

2

Sliding hip screw

Group Type: ACTIVE_COMPARATOR

Sliding Hip Screw

Intervention Type: PROCEDURE

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.

Interventions

Gamma3 intramedullary nail (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.

Intervention Type: PROCEDURE

Sliding Hip Screw

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.

Intervention Type: PROCEDURE

Other Intervention Names

Gamma Nail; Gamma3 Nail; Intramedullary Nail (IM Nail); Sliding Hip Screw (SHS); Dynamic Hip Screw (DHS); Compression Screw and Side Plate

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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stryker Osteosynthesis

UNKNOWN

Sponsor Role: collaborator

Global Research Solutions

INDUSTRY

Sponsor Role: collaborator

Stryker Trauma and Extremities

INDUSTRY

Sponsor Role: lead

Responsible Party

Stryker Trauma GmbH

Principal Investigators

Mohit Bhandari, MD FRCSC MSc

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Locations

Hamilton General Hospital

Hamilton, Ontario, Canada

St. Joseph's Hospital

Hamilton, Ontario, Canada

St. Michael's Hospital

Toronto, Ontario, Canada

Aarhus University Hospital

Aarhus, , Denmark

Sahlgrenska University Hospital

Gothenburg, , Sweden

Countries

Canada; Denmark; Sweden

References

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.

Reference Type: BACKGROUND

PMID: 8832319 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12151898 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11879828 (View on PubMed)

Other Identifiers

06042011_REGAIN_v1.0

Identifier Type: -

Identifier Source: org_study_id