POST-APPROVAL STUDY 2: HINTERMANN SERIES H3® TOTAL ANKLE REPLACEMENT SYSTEM

Date Added
June 12th, 2023
PRO Number
Pro00127864
Researcher
Christopher Gross

List of Studies


Keywords
Arthritis, Joint, Pain
Summary

Total ankle replacement has become an increasingly recommended treatment option for endstage ankle osteoarthritis over the last decades. As a result of this progress, a large variety of implant systems exist.

The Hintermann Series H3 Total Ankle Replacement System (H3) is a three-piece, mobile-bearing implant. The H3 is indicated for use as a non-cemented implant to replace a painful arthritic ankle joint due to primary osteoarthritis, post-traumatic osteoarthritis, or arthritis secondary to inflammatory disease.

The purpose of this study is to investigate long-term (up to 5 years) how the H3 implant is performing, collect information about the device through x-rays of the joint, document any complications from the device implant, see how the device affects patient quality of life.

Institution
MUSC
Recruitment Contact
Joshua Morningstar
843-792-1383
Morninjo@musc.edu

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending Dose Escalation Study to Assess the Safety and Efficacy of SL-1002 Injectable for Treatment of Knee Pain Associated with Osteoarthritis

Date Added
January 24th, 2023
PRO Number
Pro00124364
Researcher
Ameet Nagpal

List of Studies

Keywords
Arthritis, Pain
Summary

The purpose of this study is to assess the safety and efficacy of the SL-1002 injectable formulation, compared to placebo, for the treatment of knee pain associated with osteoarthritis. The study will be conducted in two parts referred to as Phase A and Phase B. In Phase A of the study, there will be a total of 3 dosing groups of subjects. Phase B of the study will enroll a single group of subjects. This study will last approximately 26 weeks, which includes a screening period that includes 2 visits. After the first two screening visits and the study drug treatment visit (Day 0), the subject will be required to return to the study site for 7 additional study visits at approximately 2 days, 1 week, 2 weeks, 1 month, 2 months, 3 months, and 6 months after the study drug treatment is administered on Day 0.

Institution
MUSC
Recruitment Contact
Lisa Mock
+18438762211
mockl@musc.edu

INFINITY with ADAPTIS Technology Total Ankle Replacement Follow-up (ITAR2)

Date Added
June 21st, 2022
PRO Number
Pro00106922
Researcher
Christopher Gross

List of Studies


Keywords
Arthritis, Joint, Pain
Summary

This implant has already been tested and been approved by the FDA and is already in use routinely in total ankle replacements within the United States. We are conducting this study to gain further knowledge about the implant. In order to do this, x-rays which have been taken as part of your routine care will be reviewed. Any additional x-rays conducted during the period of the research will also be reviewed. We are also interested in measuring improvements in patient-reported information related to quality of life and pain following implantation over a 10-year period.

Institution
MUSC
Recruitment Contact
Caroline Hoch
843-792-2434
hoch@musc.edu

Transcatheter Geniculate Arterial Embolization: Treatment and Monitoring of Response

Date Added
March 8th, 2022
PRO Number
Pro00113621
Researcher
Antony Gayed

List of Studies

Keywords
Arthritis, Pain
Summary

Twelve patients with osteoarthritis of the knee will undergo Geniculate Artery Embolization for treatment of knee pain. Prior to the procedure, patients will undergo MRI imaging of the affected knee which will include contrast enhanced images and dynamic contrast enhanced images. The MRI will measure the degree of abnormal blood flow in the synovial lining of the knee joint as well as change in the knee joint structure found in osteoarthritis. Patients will be followed at 1, 6, and 12 months after the procedure, and knee pain as well as medication usage will be assessed at each interval. At the 6-month visit, patients will undergo a second MRI with contrast that will be used to compare the changes in blood flow and knee joint structure.

Institution
MUSC
Recruitment Contact
Elise Zhao
843-792-2354
zhaoel@musc.edu

Observational Study for Pediatric Rheumatic Diseases: The CARRA Registry

Date Added
November 3rd, 2015
PRO Number
Pro00048606
Researcher
Natasha Ruth

List of Studies


Keywords
Arthritis, Autoimmune disease, Fibromyalgia, Lupus, Pediatrics, Rheumatoid, Sarcoidosis, Scleroderma
Summary

The purpose of this study is to create and maintain a registry, which is a database (a searchable collection of information) about children, adolescents and young adults with pediatric onset of rheumatic diseases. This data may help in the evaluation of the safety and benefit of medications that are prescribed to patients who have rheumatic diseases.

Institution
MUSC
Recruitment Contact
Shameeka Bowman
843-792-8317
bowm@musc.edu



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