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, find new methods of treatment through research, and provide our community with the best in orthopedic care.
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 surgery center and 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 our patients diagnosed have bone and joint diseases that are both crippling and debilitating. The Research Foundation was created to pursue medical research to further the pursuit of curing these 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 patients with immediate orthopedic diagnosis and treatment options. Our facility includes the following:
- A secure investigational storage area
- Full service, in-house surgery center, digital MRI and X-Ray, physical therapy and occupational therapy
- Dedicated, qualified, certified 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
• EMPOWER Study
- Patient has signed and received a copy of the Informed Consent form
- Chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome or intractable low back and leg pain
- Patient has been recommended by the investigator as a candidate for implantation of a Spinal Cord Stimulator (SCS)
- Patient’s age is 18 years or older
There are other requirements that you must meet before you can participate in this study. For more information, please call Kelly Wiggins, RN, CCRC @ (912) 651-8829.
• EXO-SPINE A Prospective, Multi-center, Double-blind, Randomized, Placebo Controlled Pivotal Study of Ultrasound Therapy as adjunctive Therapy for Increasing Posterolateral Fusion Success Following Single Level Posterior Instrumented Lumbar Surgery INCLUSION CRITERIA:
1. The patient must have a documented diagnosis of degenerative disc disease
2. Requires decompression at the intended fusion level
3. The subject provides written informed consent to participate in the study and is willing to comply with the study requirements for participation
4. The subject has failed non-operative treatment lasting at least 6 months
5. The subject has back pain with or without leg pain
6. The subject is between 18 and 81 years of age
There are other requirements that you must meet before you can participate in this study. For more information, please call Kelly Wiggins, RN, CCRC @ (912) 651-8829..
• TRINITY EVOLUTION Study
A Radiographic And Clinical Study Evaluating A Novel Allogeneic, Cancellous, Bone Matrix Containing Viable Stem And Osteoprogenitor Cells (Trinity Evolution™ Viable Cryopreserved Cellular Bone Matrix) In Posterior Lumbar Or Transforaminal Lumbar Interbody Fusion (PLIF Or TLIF Respectively).
- Symptomatic lumbar degenerative disc disease at 1 or 2 adjacent levels between L3 and S1
- Patients with back and/or leg pain scheduled for stabilization with or without decompression via a TLIF or PLIF approach utilizing an interbody spacer and supplemental posterior fixation.
- Greater than 18 years of age
- Unresponsive to conservative care over a period of at least 6 months or has progressive neurological signs and/or symptoms of neurological compromise that mandate urgent surgical intervention
- Willing and able to comply with the requirements of the protocol including follow-up requirements
- Willing and able to sign a study specific informed consent.
There are other requirements that you must meet before you can participate in this study. For more information, please call Kelly Wiggins, RN, CCRC @ (912) 651-8829.
• COMPLEX SPINE STUDY GROUP CSSG Multi Center Retrospective and Observational Data Registry for Clinical and Radiographic Outcomes of Complex Spine Surgeries PI: Dr. James Dewberry
This study is an information gathering study and does not involve any investigational device/product/drug.
For further information on the Orthopedic Research Foundation at optimhealthcare, please contact:
Kelly B. Wiggins, RN, CCRC
Clinical Research Coordinator
210 East DeRenne Avenue
Savannah, GA 31405
Office: (912) 651.8829
kwiggins@optimhealth.com
