Randomized Double-Blind Placebo Controlled Study of Testosterone in the Adjuvant Treatment of Postmenopausal Women with Aromatase Inhibitor Induced Arthralgias Save

Date Added
July 31st, 2017
PRO Number
Pro00056235
Researcher
Steven Corso
Keywords
Cancer/Breast, Drug Studies, Joint, Pain
Summary

It is well known that treatment with an aromatase inhibitor (AI) can cause side effects that result in symptoms such as joint pain and stiffness, which can interfere with activities of daily living. In some patients, the treatment has to be stopped because of these symptoms.

The purpose of this study is to compare the effects, good and/or bad, of the study agent, testosterone, with a placebo (an inactive agent) on joint pain caused by taking aromatase inhibitors. The testosterone/placebo is a gel that will be applied to the body in non-fat pad areas. In this study, patients will receive either the testosterone or placebo. They will not receive both.

The study agent, testosterone, used in this study is considered investigational, which means it has not been approved by the Food and Drug Administration (FDA) for routine clinical use. However, the FDA has allowed the use of this agent for this research study.

Institution
Spartanburg
Recruitment Contact
Clinical Research Department
1-800-486-5941
research@srhs.com

An Open-label Study to Assess the Safety of Repeat Administration of FX006 to Patients with Osteoarthritis of the Knee Save

Date Added
January 24th, 2017
PRO Number
Pro00062926
Researcher
Shane Woolf
Keywords
Arthritis, Drug Studies, Joint, Pain
Summary

The purpose of this study is to evaluate the safety of repeat administrations of the drug FX006 in patients who suffer from osteoarthritis of the knee. FX006 is a long lasting steroid that is injected into the knee for pain associated with osteoarthritis. Patients will be monitored monthly to ensure that they are benefiting from the injection.

Institution
MUSC
Recruitment Contact
Robert McClam
843-792-7238
mcclamr@musc.edu

Looseners versus Tighteners: Histopathology Analysis of Arthrofibrosis in Total Knee Replacement (TKA) Save

Date Added
November 3rd, 2016
PRO Number
Pro00052283
Researcher
Jacob Drew
Keywords
Aging, Arthritis, Bone, Joint, Pain, Physical Therapy
Summary

All primary total knee replacement patients will undergo the surgical procedure per the surgeon's standard technique. Samples of tissue that is ordinarily removed and discarded as a part of the procedure will be sent to the pathology lab, where the pathologist will prepare and stain the tissue sample to assess for levels of a specific protein thought to be a marker for the likelihood of the soft tissues to form dense versus loose scar tissue. We will then follow each patient's postoperative course to determine if levels of the protein in question, alpha smooth muscle actin (ASMA) correlate with outcomes. Outcomes will include postoperative pain, range of motion, as well as patient-reported satisfaction and function scores.

Institution
MUSC
Recruitment Contact
Monica Baczko
843-792-8169
baczko@musc.edu

Low vitamin D levels and outcomes after total knee and hip arthroplasty Save

Date Added
September 15th, 2016
PRO Number
Pro00053191
Researcher
Jacob Drew
Keywords
Aging, Arthritis, Bone, Joint, Nutrition, Surgery, Vitamin D
Summary

Low vitamin d levels are common among patients undergoing orthopedic surgery. However, very little is known about how vitamin d affects outcomes in patients undergoing total joint replacement surgery. Our study will look at how common low vitamin d status is among patients undergoing total hip and total knee replacement surgery. We will also look at how vitamin d levels affect complication rates and hospital readmission rates.

Institution
MUSC
Recruitment Contact
Monica Baczko
843-792-8169
baczko@musc.edu

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

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

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
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

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
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

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
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

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