Lahey Clinic’s Department of Orthopaedic Surgery Participates in Five Cutting-Edge Clinical Trials

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Scott Hartman
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Trials evaluate treatment options for three most common fractures that impact patients’ quality of life: hip, tibia, and open fractures

The Department of Orthopaedic Surgery at Lahey Clinic remains at the forefront of clinical research through its participation in five transnational, multicenter clinical trials for fracture care. The trials are designed to evaluate the contemporary treatment options for common fractures that impact patients’ quality of life. Hip fractures in elderly individuals are a major public health problem, with approximately 250,000 of these injuries occurring each year in the U.S. and an expected increase to 500,000 per year by 2020. Tibia fractures are the most common long bone injury and affect the quality of life and ability for the injured to return to work. Open fractures, or severe fractures where bone punctures the skin, necessitate timely surgical treatment to optimize patient function and outcome.

“We are thrilled to be involved in such important research. Lahey’s Orthopaedic Surgery Department has long-supported advances in fracture care, especially for these three major issues—hip, tibia, and open fractures,” said Andrew Marcantonio, DO, director of Orthopaedic Trauma. “These trials further Lahey’s dedication to pursuing the most current clinical techniques to provide our patients with the safest, most-effective treatment available.”

The following trials will take approximately two to three years for completion:

FAITH: This trial’s primary goal is to assess the impact of using sliding hip screws compared to cancellous screw fixation in individuals with femoral neck fractures. The trial will examine the rate of additional surgery required within two years of injury. Comparison studies suggest a possible benefit of a sliding hip screw over multiple cancellous screws in reducing the need for revision surgery. Enrollment for this trial is currently open.

INSITE: The purpose of this trial is to assess the effectiveness of intramedullary nails versus sliding hip screws on the healing rates and quality of life for individuals with trochanteric fractures. The current literature provides conflicting evidence on which implant improves quality of life and has a lower revision surgery and complication rate.

Identifying the optimal approach to internal fixation may improve the lives of tens of thousands of patients and reduce the economic burden of hip fractures. Enrollment began on August 7, 2012 and is open.

TRUST: The primary objective of this randomized, controlled trial is to evaluate the impact of low-intensity, pulsed ultrasound applied to tibial fractures treated with intramedullary nailing.

This study has the potential to define the role of therapeutic ultrasound in the healing of the tibia. Enrollment began at the end of 2011 and currently remains open.

FLOW: Open fractures are often complicated by infections and wound and fracture healing problems, many of which require re-operation. The purpose of this trial is to investigate whether irrigation solution or irrigation pressure will decrease re-operations among patients with open fracture wounds.

Possible benefits for subjects in this study may include a significant decrease in infection and a significant improvement in wound and fracture healing. Enrollment is currently open for this trial.

HEALTH: This trial asks: After two years following treatment, at what rate do patients over the age of 50 who suffer a displaced femoral neck fracture need additional surgery when a total hip replacement—versus partial hip replacement—is used as the initial surgical treatment?

The difference of opinion among orthopaedic surgeons and limited evidence has generated enormous enthusiasm to evaluate the merit of the two forms of hip replacement surgery. Enrollment for this trial is closed as the department has successfully reached its enrollment goals.

Lahey’s participation in these trials creates the opportunity for our physicians to improve orthopaedic care, and to refine techniques that best serve not only our patients at Lahey, but patients nationally and internationally as well.

About Lahey Clinic
Lahey Clinic, a physician-led, nonprofit group practice, is world-renowned for innovative technology, pioneering medical treatment, and leading-edge research. A teaching hospital of Tufts University School of Medicine, the Clinic provides quality health care in virtually every specialty and subspecialty, from primary care to cancer diagnosis and treatment to kidney and liver transplantation. Lahey Clinic nurses also earned Magnet status from the American Nurses Credentialing Center, a recognition only achieved by five percent of American hospitals. For more information please visit our website at www.Lahey.org.