Research

Mission Statement
The mission statement of the Orthopedic Research Foundation is to advance the health and treatment of patients with musculoskeletal diseases and trauma.

The Orthopedic Research Foundation is a collaborative effort between our highly trained physicians, a dedicated research team, and industry leaders and innovators. As the region's premier orthopedic clinic, we will continue to ensure excellence in patient care, medical research and education for the southeastern region.

Orthopedic Research Foundation
Musculoskeletal disorders are the leading cause of physical disability affecting hundreds of millions of people around the world. Many of the afflicted are children burdened with crippling bone and joint diseases. The Research Foundation was created to pursue medical research to further the pursuit of curing these debilitating disorders.

Affiliated with all hospitals in the area, the Research Foundation is a professional research organization experienced in conducting trials in device, surgical technique and pharmaceutical areas. A unique resource for phase II-IV clinical trials, the Research Foundation effectively combines rigorous quality clinical research procedures with sound business acumen. The dedicated and qualified research staff at the Research Foundation is experienced in clinical research, and strictly follows the Code of Federal Regulations, Good Clinical Practice and International Conference on Harmonisation (ICH).

By utilizing an uncompromising approach each study is carefully planned and conducted with the highest quality to accommodate sponsors and ensure patient satisfaction.

Facility Description
Our dedicated research facility provides patient with immediate orthopedic diagnosis and treatment options.

A secure investigational storage area
Full service, in-house surgery center, digital MRI and X-Ray, physical therapy and hand therapy
Dedicated, qualified research staff
Experienced physician-investigators
Dedication to the progress of research in the treatment and prevention of musculoskeletal disorders

Therapeutic Specialties
As the region’s Premier Orthopedic Surgical Center, physicians are board certified and fellowship trained. Subspecialty expertise is offered in the following areas:

Foot & Ankle
Hand & Upper Extremity
Interventional Pain Management
Joint Replacement
Pediatric Orthopedics
Spine & Neck
Sports Medicine

Current Studies
Are you suffering from back pain? Are you willing to participate in a study regarding a specific physical therapy treatment?
The physical therapy dept of Southeastern Orthopedics is studying the effect of a specific physical therapy treatment on the management of common low back pain. One hundred volunteers are needed to complete the study. Participation is free with no charge to you and will include 3 visits to the clinic and you will be given a very specific exercise to do at home.
If you are willing to participate please contact 644-5340 for details. Specifics are available here.

DuraGen Plus® Adhesion Barrier Matrix Clinical Trial
Integra LifeSciences Corporation and Southeastern Orthopedic Center is conducting a prospective, multicenter, andomized,controlled clinical trial to evaluate the safety and effectiveness of DuraGen Pius as an adhesion barrler in spinal surgery.

Why is reducing scar important in spinal surgery important?
Scarring is formed as part of the body's natural healing process following surgery. A problem occurs if this scar, called an adhesion, attaches itself to nearby structures such as nerves and muscles. Adhesions can compress or tether to the nerves causing pain, numbness, and muscle weakness after back surgery because they prevent the nerves and muscles from moving properly under normal activity.

Why, do the results of this clinical trial matter?
Unfortunately it is difficult to predict which patients are at risk for pain resulting from scar and adhesion formation. Prevention at the time of the initial surgical procedure may be the most effective method to minimize post-operative scarring and reduce the pain from adhesions.

What are the benefits of being in the study?
Patients who participate in the study have an opportunity to help the healthcare community understand and treat one of the common complications of spinal surgery. in addition, patients may be compensated for their participation in the study.*
* Certain restrictions may apply

Being in this research study does not guarantee that you will not have scar or adhesion formation or that you wilt receive the study product, but being in the study may provide the information necessary to provide treatment for scar formation and post-operative pain in the future.

What are the risks of being in the study?
Possible side effects can occur firom any spinal surgery and include pain, infection, cerebrospinal fluid leaks, hemorrhage and adhesion formation. Although not anticipated, there may be additional side effects including allergic reaction to the device. There may be risks that are unknown. Any or all of these risks may require further treatment such as surgery, or could require the possibility of extending your hospital stay.

The study product, called DuraGen Plus, is currently used as a dural substitute for the repair of the dura mater (a protective lining of the brain and spinal cord). This study will specifically evaluate the use of DuraGen Plus to minimize scarring and adhesions following lumbar disc surgery.

The safety or effectiveness of this experimental product has not been proven for the use being studied.

Integra is currently conducting the trial in several locations throughout the United States. These sites are recruiting patients of either gender who require a single- level, elective lumbar laminectomy or laminotomy procedure with discectomy in the area between L4 and S1.

You may be eligible if*:

You are between 18 and 70 years of age
Your surgeon has recommended a lumbar discectomy procedure
You have never had previous spinal surgery
You are willing to be available for follow up examinations for one year post surgery

You may not be eligible if you*:

Are involved in a lawsuit for any personal injury
Have an active Workers' Compensation claim involving the back or spine
Are pregnant or nursing or planning to become pregnant during the time of the study (up to one year following surgery)
Are an i nsulin-dependent diabetic
• Are unable to undergo MRI studies

*Additional inclusion/exclusion criteria apply.

Please consult with your physician to review the complete eligibility criteria.

If you are a patient and are interested in learning more about participating in this clinical trial, please contact the clinical research nurse at the information provided below.

Complex Spine Study Group: Multi Center Prospective Study for Clinical and Radiographic Outcomes of Spine Deformity Comparing Set Screws to Taper Lock Instrumentation, Safety and Efficacy
o PI: Dr. James Dewberry

This study is an information gathering study and does not involve any investigational device/product/drug.

For further information on Research at Southeastern Orthopedic Center, please contact

Kelly B. Wiggins, RN, CCRC
Clinical Research Coordinator
Orthopedic Research Foundation
Southeastern Orthopedic Center
210 East DeRenne Avenue
Savannah, GA 31405
Office (912) 651-8829 for information regarding ongoing research at Southeastern Orthopedic Center only
Fax (912) 644-1620