Clinical Research

Randomized non-inferiority study comparing results of the PyroCarbon Radial Head Prosthesis to the Metal Radial Head Prosthesis
Sponsor - Integra (previously Ascension)
E. Bruce Toby, MD, Principal Investigator
John Sojka, MD, Co-Investigator
Michael Tilley, MD, Co-Investigator
Archie Heddings, MD, Co-Investigator
Radial Head Implants are used to treat arthritis of the elbow and radial head fractures, as well as to replace a prior radial head implant or removal of the radial head due to complications and symptoms such as pain or loss of function.  Surgical treatment consists of removing the radial head and replacing it with a metal radial head and metal stem.  PyroCarbon is a ceramic material that has shown to cause less tension and possibly less wear to the bone than a Metal Radial Head.  The PyroCarbon Radial Head has not been approved by the US FDA and is considered investigational.  Researchers are hoping to learn how well the PyroCarbon Radial Head device works in comparison to the Metal Radial Head for this type of surgery.


Multi-Center Prospective Cohort Study:  Operative & Non-operative Treatment for Extra-articular Scapula Fractures
University of Minnesota and Vanderbilt Orthopaedic Institute
Archie Heddings, MD, Principal Investigator
John Sojka, MD, Co-Investigator
Michael Tilley, MD, Co-Investigator
Operative treatment of extra-articular scapula fractures is relatively new, as scapula fractures are relatively rare injuries and historically, have been treated non-operatively.  Significant controversy exists concerning indications for surgical care of these injuries.  However, high energy injuries are increasing in frequency due to a mechanized society and field resuscitation and a poor understanding of objective patient outcomes following these fractures has contributed to the current lack of consensus for treatment.  The primary goal of this study is to compare patient-oriented outcomes following non-operative treatment for displaced extra-articular scapula fractures to those following operative treatment.  Secondary aims include the comparison of objective functional outcomes and complication rates.


Trial to evaluate UltraSound in the Treatment of tibial fractures (TRUST)
Sponsor: Bioventus LLC (formerly Smith & Nephew, Inc.)
Funding - Canadian Institutes of Health Research (CIHR) and Smith & Nephew, Inc
Archie Heddings, MD, Principal Investigator
Co-Investigator: John Sojka, MD
Co-Investigator: Michael Tilley, MD
This is a prospective, blinded, randomized placebo-treatment controlled trial comparing the safety and effectiveness of the use of low intensity puled ultrasound in the treatment of tibial fractures treated with intramedullary nailing.  Subjects are randomized to one of two study groups; one group has active devices, the other has inactive devices.  Subjects will self-administer treatment with their study device (EXOGEN 4000+ ultrasound) for 20 minutes daily.  Treatment will continue until a central adjudication committee has determined that the fracture demonstrates radiographic evidence of bridging all 4 cortices, or until the 52-week time point. 


Multi-Center Prospective Evaulation of Operative versus Nonoperative Treatment for Adult Spinal Deformity: Differentiating Clinical and Radiographic Features and Evaluation of Treatment Outcomes
International Spine Study Group
Douglas Burton, MD, Principal Investigator
Compared to adolescent idiopathic scoliosis, operative treatment of adult scoliosis is associated with higher complication rates, prolonged recovery time, and greater economic cost. Postoperative outcomes are often compromised by complications and revision surgery. Consequently, physicians must carefully weigh the risk/benefit ratio when deciding upon operative or nonoperative treatment of adult scoliosis. There is little data currently available that considers age stratification of adult deformity patients treated operatively versus nonoperatively and followed over a period of time as regards clinical and radiographic outcomes. Psychological distress is known to have a negative impact on the outcomes of patients undergoing spine surgery.  No data exists studying the adult spinal deformity patient population with regard to psychological distress and outcome after surgery. The potential implications of this study include identifying and appropriately treating patients with significant distress and ultimately adding a data point to the surgical decision making process. 


Prospective Radiographic and Clinical Evaluation of Surgical Treatment for Cervical Deformity: A Multi-Center Study
International Spine Study Group
Douglas Burton, MD, Principal Investigator
This study aims to define the clinical and demographic features of the population affected by cervical deformities such as cervical kyphosis, cervical scoliosis, and basilar invagination. The study will assess for correlations between radiographic parameters and degree of pain/disability at baseline and assess and describe surgical strategies used to address the deformity and evaluate clinical outcome at 2 years following surgery.


 A Prospective, Multicenter Study of Instrumented Posterolateral Lumbar Fusions (PLF) with OsteoAMP to Evaluate Long-Term Safety and Efficacy in Patients Requiring 1-2 Level Instrumented PLF
Sponsor: Bioventus LLC.
Douglas Burton,MD, Principle Investigator
This study aims to evaluate the long-term safety and efficacy of OsteoAMP in patients requiring 1-2 contiguous level, instrumented posterolateral spinal fusion procedure of the lumbar and/or sacral spine.

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Operative Treatment of Adult Low Grade Lumbar Spondylolisthesis: Evaluation of Treatment Strategies, Radiographic Parameters, and Patient Outcomes.
International Spine Study Group
Douglas Burton, MD, KUMC Principle Investigator
The specific aims of this study are to determine the importance of segmental sagittal alignment in the treatment outcomes of adult low grade lumbar spondylolisthesis. The study also evaluated the following: the health related quality of life (HRQOL) outcomes and complication rates associated with treatment of adult low grade lumbar spondylolisthesis, symptoms that are most responsive to surgical treatment for adult low grade lumbar spondylolisthesis including leg and back pain, and identify treatment strategies that are most effective in relieving corresponding symptoms, and cost effectiveness for different surgical treatment strategies for adult low grade lumbar spondylolisthesis

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Cost Effectiveness of Nonoperative Management for Adult Spinal Deformity Associated with Low Grade Scoliosis: A Prospective Study to Evaluate Disease Burden and Longitudinal Study Feasibility
International Spine Study Group
Douglas Burton,MD, KUMC Principle Investigator
This study seeks to Identify disease burden associated with adult spinal deformity (ASD) due to low grade scoliosis/spinal deformity and use health related quality of life (HQOL) questionnaires to establish disease burden and establish standardized data collection methodology for economic based outcome studies based upon patient demographics and HRQOL values.

Last modified: Mar 01, 2016
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