Research at the Ohio Orthopedic Center of Excellence

Healing of problematic fractures has long been a focus in orthopedic surgery. Read more about how Dr. Pete Edwards of the Ohio Orthopedic Center of Excellence and Eli Lilly & Company have teamed up to study The Use of Teriparatide (Forteo) as an Adjunctive Therapy for the Treatment of Jones Fractures

The Ohio Orthopedic Center of Excellence Dr. Pete Edwards  and Eli Lilly & Company have something in common: a focus on finding new treatment for problematic fractures. Read more about how they have teamed up to research The Use of Teriparatide (Forteo) as an Adjunctive Therapy for the Treatment of Jones Fractures.

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At the Ohio Orthopedic Center of Excellence Foundation, we strive toward an environment that fosters and promotes cutting-edge clinical research conducted in various orthopedic sub specialties. In compliance with all federal, state, and sponsor requirements, we seek to answer questions and find solutions to expand the understanding of orthopedic disorders, treatments, and prevention.

A new exciting endeavor is in the air at the Ohio Orthopedic Center of Excellence Foundation. With the recent addition of our first ever “in house” clinical research coordinator, our physicians have been active in facilitating several clinical research trials.

Dr. William Fitz, chairman of the foundation board is currently pursuing a prospective study designed to identify new treatment options for chronic spine pain entitled Hyperbaric Oxygen Therapy for the Treatment of Degenerative Disc Disease of the Spine: A Pilot Study. The Hyperbaric Oxygen Chamber is a form of inhalation therapy in which patients breathe pure oxygen at greater than one atmosphere of pressure. Dr. Fitz specializes in the diagnosis and non-surgical care of spinal disorders. He also has expertise in electro diagnostic testing, which helps pinpoint the nature of disorders of the peripheral nervous system.

Dr. Pete Edwards is a Fellowship Trained Board Certified Sports Medicine surgeon at The Ohio Orthopedic Center of Excellence. His practice has an emphasis on arthroscopic surgery of the knee and ankle of all ages as well as a specialized focus on soccer sports medicine. Dr. Edwards research agenda is established in understanding and preventing injuries in athletes. With a database quickly growing to over 600 entries Dr. Edwards study entitled Posterolateral Tibial Plateau Fractures vs. Bone Bruises in Association with ACL injuries will propose a classification system based on MRI and radiographic findings that will assist the sports medicine physician in identifying two common types of concomitant injuries, bone bruises and posterolateral tibial plateau fractures in the ACL injured knee. Dr. Edwards also has several other clinical studies to support his research agenda.

Dr. Joseph Mileti, Board Certified Orthopedic Surgeon is Fellowship Trained in reconstruction and replacement of the shoulder and elbow, and sports medicine. With a passion to teach, Dr. Mileti along with Dr. Jonathon Gant an Orthopedic Resident at The Ohio State University are conducting a study looking at the Intramedullary Fixation of Midshaft Clavicle Fractures. The clavicle is the most commonly fractures bone in the human skeleton. Along with the accepted treatment of plate fixation, intramedullary fixation of clavicle fractures in gaining popularity. This investigation will study the radiographic and functional outcomes of patients treated at a single institution with an intramedullary clavicle pin.

The Ohio Orthopedic Center of Excellence has also been selected to participate in multi-center industry sponsored clinical studies.

Posterolateral Tibial Plateau Fractures vs. Bone Bruises in Association with ACL injuries

Principal Investigator: Peter H. Edwards, Jr. MD

Anterior cruciate ligament (ACL) injuries are a predominant cause of knee problems requiring medical attention and often arise during contact sports. ACL injuries often are associated with concomitant injuries, including bone bruising, posterolateral tibial plateau fractures, and meniscal tears. If undiagnosed, such concomitant injuries not only impact an athlete’s return to sports participation, but also may have long-term consequences on the overall health of the knee. Numerous studies have been conducted documenting the presence of concomitant injuries associated with ACL ruptures, as well as demonstrating the success of MRI in detecting these injuries. A classification system, however, that incorporates MRI findings with other diagnostic test results may be useful to physicians in diagnosing concomitant injuries in the ACL-injured knee and has not been developed previously. This study proposes a classification system based on MRI and radiographic findings that will assist the sports medicine physician in identifying two common types of concomitant injuries, bone bruises and posterolateral tibial plateau fractures, in the ACL-injured knee. Approximately 600 patients with ACL injuries will be assessed retrospectively to assist in refining the proposed classification system. The identification of these injuries prior to ACL reconstruction through the use of a standardized classification system may lead to earlier and more effective treatment for sequelae associated with a given ACL injury grade that may have been delayed if not previously identified.

Functional Outcome of Revision ACL Reconstruction Using a Bone-Patellar Tendon Bone Non-Irradiated Allograft

Principal Investigator: Peter H. Edwards, Jr., MD

Injuries to the ACL are common in the athletic population and are becoming more frequent with today’s emphasis on fitness and activity. The increasing number of primary ACL reconstruction has led to a corresponding rise in revision ACL surgeries. However, literature regarding revision ACL reconstruction is limited, with most studies consisting of small, retrospective case series. The purpose of this study is to evaluate the functional outcomes following revision ACL reconstruction using a bone-patellar tendon bone non-irradiated allograft. Approximately 15 to 30 patients who underwent revision bone-patellar tendon bone ACL reconstruction with a non-irradiated allograft performed by the principal investigator between 2004 and 2009 will assessed postoperatively to obtain updated functional outcomes. Efficacy of the revision ACL reconstruction treatment will be assessed by the absence of addition surgical reconstruction, as well as by arthrometer measurements using a KT-1000 device, which measures knee laxity. The Lysholm knee scale, which evaluates symptoms relating to knee function, will be used as an additional efficacy endpoint. Final radiographs also will be obtained to evaluate the development of osteoarthritis. Patients’ perceived pain, function, and sports participation related to the revision ACL procedure will be assessed by the Tegner Activity Scale and the Cincinnati Knee Rating System. We expect to provide evidence that ACL reconstruction using a non-irradiated bone patellar tendon-bone technique compares favorably with previously published studies.

Hyperbaric Oxygen Therapy for the Treatment of Degenerative Disc Disease of the Spine: A Pilot Study

Principal Investigator: William R. Fitz, MD

Hyperbaric oxygen (HBO) is a form of inhalation therapy in which patients breathe pure oxygen at greater than one atmosphere of pressure. HBO has been utilized as a treatment modality for many conditions, including decompression sickness, arterial gas embolism, carbon monoxide poisoning, osteoradionecrosis, compromised skin grafts/flap, gas gangrene, necrotizing soft tissue infections, refractory osteomyelitis, crush injuries, diabetic foot problems, and spinal cord injuries. The intervertebral disc is the largest avascular structure in the body. Small blood vessels lie on the surface of the annulus fibrosis, with some penetrating a short distance into the outer layers of the annulus. Hyperbaric oxygen therapy increases oxygen delivery to tissues by increasing dissolved plasma oxygen content, which has led to its use in both chronic and acute ischemic conditions. If the degradation of the intervertebral disc is driven by hypoxia, then hyperbaric oxygen therapy may be found to be a regenerative treatment for painful degenerative disc disease. To date, no studies evaluating the use of HBO for the treatment of degenerative disc disease have been reported. The purpose of this prospective pilot study will evaluate the functional outcomes of HBO therapy for degenerative disc disease management. Twenty-four patients with degenerative disc disease will undergo HBO therapy consisting of 100% oxygen at two atmospheres (ATM) of pressure. Therapy will be administered for ninety minutes twice daily for five days. Patients will be evaluated pre-HBO treatment and at 1, 3, 6, 12, and 24 weeks after treatment. Efficacy of HBO therapy will be assessed using the Visual Analog Pain Scale, which measures pain, and the standardized Oswestry Disability Index, which assesses pain, function, and activities of daily living. Safety of HBO therapy will be evaluated by the incidence of adverse events. The goal of this study is to make a significant contribution to the current knowledge base of HBO therapy and degenerative disc management by being the first study to directly assess functional outcome of HBO therapy for the treatment of degenerative disc disease.

Intramedullary Fixation of Midshaft Clavicle Fractures

Principal Investigator: Joseph Mileti, M.D.

The clavicle is the most commonly fractured bone in the human skeleton. Approximately 80% of all clavicle fractures occur at the midshaft of the bone. Traditionally, clavicle fractures have been treated non-operatively with exceptionally good healing and functional outcomes. However, recent literature, which employs patient-oriented outcome measures, indicates that up to 30% of patients treated non-operatively have unsatisfactory outcomes. Studies suggest that the amount of residual fracture displacement and shortening correlates with poor clinical, radiographic, and subjective outcomes and recommend surgical treatment for these fractures. Along with the accepted treatment of plate fixation, intramedullary fixation of clavicle fractures is gaining popularity. Advantages of intramedullary fixation compared to plate fixation include smaller skin incisions, less soft-tissue stripping at the fracture site, easier hardware removal, and less weakness of bone after hardware removal. However, few studies have investigated the functional outcomes of patients treated with intramedullary pin fixation. This investigation will study the radiographic and functional outcomes of patients treated at a single institution with an intramedullary clavicle pin. Approximately 20 patients with displaced and shortened midshaft clavicle fractures will be assessed postoperatively at a minimum of 12-month follow-up to obtain updated functional and radiographic outcomes. Safety will be assessed through review of radiographs and operative notes to document any postoperative complications occurring during or after the surgery. Efficacy of the intramedullary pin will be assessed utilizing the American Shoulder and Elbow Surgeons Shoulder Scoring System and Constant Shoulder Scoring System. Final radiographs also will be obtained to assess fracture reduction and fracture healing. The ultimate goal of this study is to demonstrate the clinical and functional outcomes of patients who underwent intramedullary pin fixation for midshaft clavicle fractures with significant displacement and shortening, as well as to better define the appropriate patient population that will most likely benefit from this type of treatment.

Functional Outcome of Patients Treated with the Proximal Humeral Locking Plate for Unstable Fractures of the Proximal Humerus

Principal Investigator: Joseph Mileti, M.D.

Proximal humeral fractures account for 4 to 5 percent of all fractures and are the third most common fracture in patients over age 65. Approximately 80 percent of these fractures are minimally displaced and stable and may be adequately treated nonoperatively. The remaining 20 percent of these fractures are displaced or unstable with no existing universally treatment method. The 3.5 mm LCP Proximal Humerus Plate (Synthes, Inc. West Chester, PA) is a relatively new implant designed for the treatment of unstable and displaced proximal humeral fractures. Few studies have investigated the functional outcome of patients treated with the proximal humeral locking plate by a single surgeon. This investigation will study the radiographic and functional outcomes of patients treated by a single surgeon with a proximal humeral locking plate. Approximately 50 patients with unstable or displaced proximal humeral fractures will be assessed postoperatively at a minimum of 12-month follow-up to obtain updated functional and radiographic outcomes. Safety will be assessed through review of radiographs and operative notes to document any complications occurring during or after the surgery. Efficacy of the proximal humeral locking plate treatment will be assessed by utilizing the American Shoulder and Elbow Surgeons Shoulder Scoring System. Final radiographs also will be obtained to assess the adequacy of fracture reduction, fracture healing and the presence of a vascular necrosis. The ultimate goal of this study is to demonstrate the safety and effectiveness of this type of device, as well as to better define the appropriate patient population that will most likely benefit from this type of treatment.

Functional Outcome of Revision ACL Reconstruction Using a Bone-Patellar Tendon-Bone Non Irradiated Allograft

 

If you have any questions regarding any of the studies conducted at the OOCE, or would like more information as to how to participate in research please contact Lindsay Arnott, Clinical Research Coordinator at 614-827-8375 or by email at larnott@ohio-ortho.com