EVoluSIon Study using the Zyga SImmetry® Sacroiliac Joint Fusion System (EVSI) Save

Date Added
June 28th, 2016
PRO Number
Pro00055312
Researcher
Stephen Kalhorn

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Keywords
Joint
Summary

Subjects are being asked to volunteer for this research study because your doctor feels that there is a significant probability that your sacroiliac joint (SIJ) contributes to your back pain and that you may be a candidate for sacroiliac surgery. If you meet the study requirements you will have a surgical procedure to have SImmetry devices implanted in your body.The SImmetry Sacroiliac Joint Fusion System is a device approved by the U.S. Food and Drug Administration (FDA).

This study will collect data to better understand pain reduction on your sacroiliac joint (low back/buttock) after implantation of the SImmetry Sacroiliac Joint Fusion device. Subjects will complete a total of 5 visits over the course of 2 years.

Institution
MUSC
Recruitment Contact
Aparna Choudhury
843-792-2845
choudhur@musc.edu

Analysis of Risk Factors for Aspiration Positive Septic Arthritis Save

Date Added
June 14th, 2016
PRO Number
Pro00054010
Researcher
Thomas Ergen
Keywords
Joint
Summary

Patients who present with a native joint complaint and consent for the study will be tracked and their standard of care data will be monitored for outcomes of a septic joint. There are no additional actions taken outside of the standard of care. The results after the subject goal has been met will allow us to have a better understanding of the criteria for a septic joint.

Institution
Palmetto
Recruitment Contact
Kayla Cole
8032969200
kayla.cole@gmail.com

Comparative Effectiveness of Pulmonary Embolism Prevention after Hip and Knee Replacement: Balancing Safety and Effectiveness Save

Date Added
April 19th, 2016
PRO Number
Pro00053742
Researcher
Vincent Pellegrini

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Keywords
Drug Studies, Joint
Summary

PEPPER is a randomized study comparing the three most commonly used blood thinners in North America in patients who have elected to undergo primary or revision hip or knee joint replacement surgery. The blood thinners being compared are enteric coated aspirin plus air pump compression, low intensity warfarin, and rivaroxaban.

Institution
MUSC
Recruitment Contact
Monica Baczko
843-792-8169
baczko@gmail.com

Discontinuation From Chronic Opioid Therapy For Pain Using a Buprenorphine Taper Save

Date Added
September 1st, 2015
PRO Number
Pro00046473
Researcher
Kelly Barth

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Keywords
Drug Studies, Fibromyalgia, Joint, Pain, Substance Use
Summary

Chronic opioid therapy for pain can be associated with significant risks, and a significant number of patients maintained on chronic opioids have continued pain and/or poor functioning. When patients need to or want to come off their opioid pain medications, there is little to guide physicians as to how to best help them do so, and it is not known how patients do after coming off opioid medications. The goals of this study are (1) to evaluate two medications in assisting patients in coming off their opioid pain medications and (2) determining outcomes after discontinuing opioids.

Institution
MUSC
Recruitment Contact
Kayla Whaley
843-792-0684
whaley@musc.edu

A Post-Market Domestic (US) and International Data Collection to Assess Hip Replacement Systems Manufactured and/or Distributed by Exactech. Save

Date Added
February 18th, 2014
PRO Number
Pro00030758
Researcher
Richard Friedman

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Keywords
Joint, Pain, Surgery
Summary

To collect data to further affirm the safety and effectiveness of the hip replacement systems manufactured and/or dustrubuted by Exactech, Inc. Data will be collected in order to provide post-market subjective and objective evidence of safety and effectivenss. Data may be analyzed to support future presentation and publication of theses systems and will be made available in the event Exactech is required to provide clinical evidence of the post market outcomes of the devices.

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

A Post-Market Domestic (US) and International Data Collection to Assess the Optetrak® Knee Stystem. Save

Date Added
February 18th, 2014
PRO Number
Pro00030785
Researcher
Richard Friedman

Silhouette
Keywords
Joint, Pain, Surgery
Summary

The study will collect data to further affirm the safety and effectiveness of the Optetrak® Knee System product lines. Data will be collected in order to provide post-market subjective and objective evidednce of safety and effectivness. Data may be analyzed to support future presentation and publication of the Optetrak® Knee Systems and will be made available in the event Exactech is required to provide clinical evidence of the post market outcomes of the Optetrak Knee devices.

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

An Open Label, Multi-Center, Retrospective and Prospective Evaluation of Shoulder Arthroplasty Clinical and Radiographic Outcomes Save

Date Added
February 18th, 2014
PRO Number
Pro00030914
Researcher
Richard Friedman

Silhouette
Keywords
Joint, Pain, Surgery
Summary

The purpose of this study is to collect and evaluate clinical and radiographic outcomes data on patients who have undergone, or will undergo, shoulder replacement surgery. Patients who receive a device from the Equinoxe® Shoulder System, manufactured and distributed by Exactech, Inc as well as patients who receive a device from another shoulder arthroplasty system may be included in this study.

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

Systemic Lupus Erythematosus in Gullah Health (SLEIGH) Save

Date Added
October 5th, 2009
IRB Number
10852
Researcher
Diane Kamen

Silhouette
Keywords
Autoimmune disease, Children's Health, Environmental Factors, Ethnicity and Disease, Healthy Volunteer Studies, Immune System, Joint, Kidney, Lupus, Minorities, Non-interventional, Vitamin D, Women's Health
Summary

The Systemic Lupus Erythematosus (SLE) in Gullah Health, or SLEIGH, study is an observational study enrolling African Americans from the Sea Island communities of South Carolina and Georgia. We are enrolling patients, family members of patients, and unrelated community members. SLE is a potentially severe disease that can affect the entire body. SLE is more common in African Americans than Caucasians. The main purpose of this study is to find genes that, along with factors from the environment, result in the development of SLE. Volunteers in SLEIGH will be asked to answer questions about their health and have blood and urine collected for tests. After the first visit there may be one additional visit 2 or more years later. This is not a drug study.

Institution
MUSC
Recruitment Contact
Stephanie Slan
843-792-8997
slans@musc.edu

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