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Clinical Research

The Effect of Dynamic Stabilizers for Valgus Stability of the Elbow in Professional Baseball Players (UCL Study):
PI: E Bruce Toby, MD; Brandon Morris, MD; Vincent Key, MD; Evan Glidewell, BS, McIff TE.
This study involves the testing of minor league baseball pitchers. The purpose of the study is to learn whether the muscles on the medial side of the elbow can help prevent ulnar collateral ligament (UCL) injuries to the elbow. Additionally, we want to know whether measurements of the strength of these muscles can be used to predict elbow injuries.

Femoroacetabular Impingement (FAI): The Effectiveness of Physical Therapy Protocol:
PI: Scott Mullen, MD; Paul Schroeppel, MD
Sponsor: Steadman Hawkins Clinic - Denver
By doing this observational study, researchers hope to learn if physical therapy helps patients with FAI reduce pain and inflammation. 

Fixator Debridement
PI: Archie Heddings, MD.
The purpose is to review whether performing an irrigation and debridement of the pin sites on patients that underwent external fixator removal, decreased post-operative infection rates.

Multi-Center Prospective Evaluation 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.

Mature Runners: The Effect of Training Shoes upon Running Kinematics:
PI: E Bruce Toby, MD; Scott Mullen, MD; Heath Melugin, MD; Damon Mar, MS; Terence McIff, Ph.D.
The purpose of this study is to learn whether the type of shoe a mature runner wears causes him/her to strike the ground differently.

A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Staphylococcus Aureus 4-Antigen Vaccine (SA4Ag) in Adults Undergoing Elective Open Posterior Spinal Fusion Procedures with Multilevel Instrumentation
PI: Douglas Burton, MD; Sean Jackson, MD.
Sponsor: Pfizer
SA4Ag is an investigational vaccine being studied to determine whether vaccination with SA4Ag, given 10 to 60 days before surgery, can help prevent infections after surgery caused by staph.

METRC Studies:
PI: Michael Tilley, MD; John Sojka, MD; Archie Heddings, MD. Terence E. McIff Ph.D. 
Sponsor: Department of Defense
BIOBURDEN: Open Type III tibia fractures or transtibial amputations that require a second closure, skin grafting, or flap coverage procedure following fixation. The primary objective is to characterize the contemporary extremity wound "bioburden" at the time of definitive wound closure of severe extremity wounds.
STREAM: Streamlining Trauma Research Evaluation with Advanced Measurement (STREAM). This is a multi-center, prospective longitudinal observational study to evaluate the reliability, validity, and responsiveness of PROMIS tools in orthopedic trauma patients.

Prospective Multi-Center Adult Spinal Deformity Outcomes Registry
PI: Douglas Burton, MD.
Sponsor: International Spine Study Group Foundation
The purpose of this study is to create a registry. The registry will be used by the researchers to learn how your clinical characteristics and radiographic images might change over time. By doing this study, researchers hope to learn the clinical characteristics that separate adult operative and non-operative patients.

Issues for Senior Female Physicians:
PI: Kimberly Templeton, MD; Anne Walling, MD
This study is looking to identify leading work and personal issues for women physicians 60 years of age and older.

Identifying Predictive Factors for Trauma Recidivism
PI: Archie Heddings, MD; Jessica Brozek, MD
The goal of this study is to identify risk factors associated with repetitive traumatic injury, quantify repeat trauma patients within KU health system, and determine the financial burden of repeat trauma.

Comparing clinical outcomes and imaging findings (callus formation) of Far cortical locking plate technology to standard plating techniques for fracture treatment.
PI: Michael Tilley, MD; Michael Bokemper, MD; Brandon Carlson, MD.
Far cortical locking plate technology (FCL) is a relatively new technology in the treatment of long bone fractures. While biomechanical studies support the use of the FCL for the treatment of long bone fractures, there are very few clinical studies published to date either supporting or detracting from the use of the technology. The significance of the proposed research is to compare treatment outcomes both radiographically and clinically to standard treatment techniques to determine if there is a difference in clinical outcomes.

Pain and Activity Level Related to Spine Surgery and Patient Outcomes
PI: Brittany Melton, MD; Neena Sharma, MD; Douglas Burton, MD.
Researchers hope to learn about the relationship between pain management and activity level immediately after spine surgery and patient outcomes/healthcare costs after going home.

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.
PI: Douglas Burton, MD; Sean Jackson, MD.
Sponsor: Bioventus, LLC
This study is a post market study to gather long term safety and effectiveness of OsteoAMP.

Lisfranc Injuries and Cost and Complications of Treatment, Comparison of ORIF and Primary Fusion, A PearlDiver Study
PI: Bryan Vopat, MD.; Brandon Barnds, MD.; William Tucker, MD
The purpose of this study is to evaluate the outcomes of operative vs non-operative treatments of lisfranc injuries, using data from the PearlDiver database.

Meniscal Tears: Cost, Sex Analysis and Progression to Knee Arthroplasty (KA), Comparison of Non-Operative Management versus Arthroscopic Partial Meniscectomy (APM), A PearlDiver Study.
PI: Bryan Vopat, MD.; Brandon Barnds, MD.; Brandon Morris, MD.; Paul Schroeppel, MD.; Scott Mullen, MD.; Armin Tarakemeh
This study will use the PearlDiver database to compare the cost, sex treatment trends, and progression to KA associated with meniscal tears in subjects treated non-operatively and in those treated with APM.

Survival of Carpal Instability Procedures, a PearlDiver Study.
PI: E. Bruce Toby, MD; Daniel Reinhardt, MD.; Jacob Brubacher, MD
The purpose of this study is to learn about the outcomes of patients that undergo wrist ligament repair procedures for carpal instability.

Radial Head Replacement versus Open Reduction and Internal Fixation of Radial Head Fractures in Terrible Triad Injuries, A PearlDiver Study
PI: E. Bruce Toby, MD; Daniel Reinhardt, MD.; Jacob Brubacher, MD.
Using the PearlDiver database, we will compare patients with terrible triad injuries that have undergone ORIF and RHA of radial head fractures to learn the outcomes of each group.

Arthrex SOS Study: Orthopedic Sports Medicine, Arthroscopy, and Related Surgery Registry Using the Web-based Surgical Outcomes System (SOS).
Sponsor: Arthrex, Inc
PI: J. Paul Schroeppel, MD.; Scott Mullen, MD.; Bryan Vopat, MD.; Vincent Key, MD.
The purpose of this study is to create a registry to be used by researchers to learn more about the post-surgical outcomes and cost effectiveness of surgical procedures.

KU School of Medicine

University of Kansas Medical Center
Department of Orthopedic Surgery and Sports Medicine
Mail Stop 3017
3901 Rainbow Boulevard
Kansas City, KS 66160