Operative versus Non-Operative Treatment for Atraumatic Rotator Cuff Tears: A Multicenter Randomized Controlled Pragmatic Trial Save

Date Added
October 7th, 2019
PRO Number
Pro00088804
Researcher
Josef Eichinger

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Keywords
Bone, Joint, Physical Therapy, Surgery
Summary

Patients of age ?50 to <85 years diagnosed with a rotator cuff tear (with MRI confirmation) who are fit for either arthroscopic rotator cuff surgery or physical therapy will be recruited. The study will compare pain and function in patients undergoing operative versus non-operative treatment of Non traumatic rotator cuff tears at 12 months of follow-up.

Institution
MUSC
Recruitment Contact
Lisa Mock
843-876-2211
mockl@musc.edu

tDCS Combined with a Brief Cognitive Intervention to Reduce Perioperative Pain and Opioid Requirements in Veterans Save

Date Added
October 1st, 2019
PRO Number
Pro00091450
Researcher
Jeffrey Borckardt

List of Studies


Profiles_link
Keywords
Brain, Joint, Mental Health, Military, Pain, Psychiatry, Surgery
Summary

The purpose of this study is to determine whether a new medical technology can help reduce post-operative total knee or hip pain when combined with a Cognitive-Behavioral intervention (CBI).

This new medical technology, is called transcranial direct current stimulation (tDCS), it uses a very small amount of electricity to temporarily stimulate specific areas of the brain thought to be involved in pain reduction. The electrical current passes through the skin, scalp, hair, and skull and requires no additional medication, sedation, or needles.

This study will investigate the effects of tDCS, the Cognitive-Behavioral (CB) intervention and their combination on pain among veterans following total knee arthroplasty (TKA) or total hip arthroplasty (THA). You may benefit in the form of decreased pain and opioid requirements following your knee or hip replacement surgery. However, benefit is only likely if you are randomized to one of the 3 (out of 4) groups.

This study hopes to determine the effects of these interventions and their combined effect on post-operative pain, opioid use and functioning during the 48-hour post-operative period following a total knee or hip replacement.

Institution
MUSC
Recruitment Contact
Georgia Mappin
(843) 789-7104
georgia.mappin@va.gov

Assessing Mental Health Resources in U.S. Trauma Centers for Families Affected by Pediatric Traumatic Injury Save

Date Added
September 27th, 2019
PRO Number
Pro00091869
Researcher
Leigh Ridings

List of Studies

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Keywords
Children's Health, Depression, Mental Health, Pediatrics, Surgery
Summary

Pediatric traumatic injury (PTI) ? defined as unintentional injury requiring hospitalization and, often, extended periods of physical and emotional recovery ? is experienced by 300,000 children in the U.S. annually. Roughly 20-40% of children and caregivers develop posttraumatic stress disorder (PTSD) and/or depression following PTI, yet most U.S. trauma centers fail to provide even basic mental health screening post-injury. It is critical to advance our knowledge of available mental health services in trauma centers for this frequently overlooked population to accelerate their physical and emotional recovery. In this project, trauma center providers across the U.S. will complete a survey and a qualitative interview to assess their current protocols and resources available to screen and treat children and families' mental health in the aftermath of PTI, as well as their opinions regarding feasibility of implementing protocols to better address the emotional health recovery within this population.

Institution
MUSC
Recruitment Contact
Leigh Ridings
843-792-5146
ridingle@musc.edu

A Randomized Controlled Trial Comparing Monitored Anesthesia Care versus General Anesthesia with Transesophgeal Echocardiography for Transcatheter Aortic Valve Replacement Save

Date Added
June 18th, 2019
PRO Number
Pro00088473
Researcher
George Whitener

List of Studies


Profiles_link
Keywords
Cardiovascular, Heart, Surgery
Summary

This study is being done to evaluate the impact that monitored anesthetic care (MAC) versus general endotracheal anesthesia (GETA) has on hospital length of stay, rate of ICU admission, or procedural mortality. Also, we hope to determine if the use of Transesophageal Echocardiography (TEE) during GETA impacts device success and durability. Adult patients undergoing transfemoral approach TAVR for aortic valve stenosis may be eligible candidates for this study.

Institution
MUSC
Recruitment Contact
Christine Aanstoos
8437921869
aanstoos@musc.edu

Randomized, controlled trial of post-operative steroids and pain control after tonsillectomy Save

Date Added
October 2nd, 2018
PRO Number
Pro00081346
Researcher
Clarice Clemmens

List of Studies

Silhouette
Keywords
Pain, Surgery
Summary

Pain control after tonsillectomy is imperative but often difficult. Current post-operative pain medication regimens include opioid analgesics and are often still inadequate. Though not standard of care, it is our practice to prescribe a single dose of oral steroid medication on the third day after surgery, when pain and swelling are at their peak, in order to assist with pain control and reduce opioid consumption. Though this practice has a rational theoretical basis, there is no prospective data supporting or discounting it. We aim to compare pain control, opioid consumption, and complication rates in children receiving post-operative steroids versus those who do not.

Institution
MUSC
Recruitment Contact
Joshua Horton
843-792-2300
hortojos@usc.edu

A RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED, PHASE 3 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF QPI-1002 FOR THE PREVENTION OF MAJOR ADVERSE KIDNEY EVENTS (MAKE) IN SUBJECTS AT HIGH RISK FOR ACUTE KIDNEY INJURY (AKI) FOLLOWING CARDIAC SURGERY Save

Date Added
September 4th, 2018
PRO Number
Pro00080148
Researcher
Marc Katz

List of Studies

Silhouette
Keywords
Drug Studies, Heart, Kidney, Surgery
Summary

The purpose of this study is to test whether the study drug (QPI-1002) prevents Major Adverse Kidney Events (MAKE) after heart surgery in adult patients who are at high risk of developing Acute Kidney Injuries (AKI). This study is a one-time infusion of the study drug (QPI-1002) with follow-up visits lasting for one year.

Institution
MUSC
Recruitment Contact
Morgan Overstreet
843-792-8896
overstrm@musc.edu

The pathogenesis of Post-Traumatic Pulmonary Embolism: A Prospective Multicenter Investigation by the CLOTT Study Group: Part I Save

Date Added
August 30th, 2018
PRO Number
Pro00075379
Researcher
Bruce Crookes

List of Studies


Profiles_link
Keywords
Surgery
Summary

Venous thromboembolism, which includes both deep vein thrombosis (DVT) and pulmonary embolism (PE), is a common complication after injury. PE carries a mortality rate of 11% and is the third leading cause of death after injury. Traditionally, PE has been thought to originate from a clot in the lower extremities or vena cava that migrates to the lungs. However, with the liberal use of computed tomography after injury, many small thrombi (pulmonary thrombi or PT) are being found in the pulmonary arteries that may be de novo clots that arise due to pulmonary injury or inflamation. This novel finding has major implications for both prophylaxis and treatment. The CLOTT study group that includes 17 investigators from 17 major trauma centers could not come to a consensus as to the treatment of asymptomatic PT. This prospective observational multicenter study will collect data from seriously injured patients who develope PE/PT admitted to any of our 17 trauma centers without altering the standard of care at any center allowing us to compare two treatment patterns: anticoagulation versus observation. If this study supports our hypothesis that occult PT do not need specific treatment, it would have a major impact on practice patterns and would prevent overtreatment in a large number of injured patients.

Institution
MUSC
Recruitment Contact
Bruce Crookes
(843) 872-3780
crookes@musc.edu

Optimal Resuscitation in Pediatric Trauma - an EAST Multi-center Study Save

Date Added
August 15th, 2018
PRO Number
Pro00078600
Researcher
Christian Streck

List of Studies


Profiles_link
Keywords
Pediatrics, Surgery
Summary

This study will focus on collecting coded patient data from pediatric traumas prospectively. Data will be collected to assess inclusion of patients that fit the inclusion criteria of <18 years old with an elevated shock index based on age (Form A). There will also be a post-resuscitation data collection to examine products given to pediatric patients with an elevated shock index (Form B).
These data collection forms will help us determine the impact on primary outcomes of crystalloid administration volume and timing prior to blood products in children presenting in shock following trauma.
We will assess patient factors that predict need for early transfusion of blood products and clotting factors in pediatric trauma patients presenting in shock. We will also relate primary outcomes to ratio of blood products in pediatric trauma patients in shock who are transfused. We will also evaluate the role of clotting factor administration on coagulation studies. This study will help define variability in pediatric trauma fluid and blood resuscitation practices between centers.

Institution
MUSC
Recruitment Contact
Denise Garcia
843-754-8555
garciad@musc.edu

Direct measurement of motor cortical responses to transcranial direct current stimulation Save

Date Added
May 15th, 2018
PRO Number
Pro00073545
Researcher
Nathan Rowland

List of Studies

Silhouette
Keywords
Brain, Central Nervous System, Movement Disorders, Muscle, Nerve, Nervous System, Parkinsons, Surgery
Summary

Transcranial direct current stimulation (tDCS) has shown the potential to improve symptoms in patients with motor deficits, however its effects have not been consistent in randomized studies to date, limiting widespread adoption of this technology. A critical gap in our knowledge is a detailed understanding of how tDCS affects motor areas in the brain. We propose using tDCS while recording directly from motor cortex using subdural electrocorticography (sECoG) in patients undergoing deep brain stimulation surgery. We expect this novel approach to broaden our understanding of tDCS application and possibly lead to therapeutic advances in this population.

Institution
MUSC
Recruitment Contact
Sanicqua Robinson Smalls
843-792-8553
robinsst@musc.edu

Utilization of quadratus lumborum block for postoperative analgesia following hip arthroscopy: A prospective, randomized clinical trial. Save

Date Added
March 20th, 2018
PRO Number
Pro00076191
Researcher
Sylvia Wilson

List of Studies


Profiles_link
Keywords
Surgery
Summary

The purpose of this research study is to find out if a nerve block named quadratus lumborum block (QL) can provide better pain relief than having no nerve block for patients having their surgery on their hip through several small incisions while the surgeon looks with a camera (hip arthroscopy).

Institution
MUSC
Recruitment Contact
Wanda Jones
843-792-1869
joneswr@musc.edu

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