A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of FX006 in Patients With Glenohumeral Osteoarthritis or Shoulder Adhesive Capsulitis (RANGE). Save

Date Added
April 14th, 2020
PRO Number
Pro00097836
Researcher
Josef Eichinger

List of Studies

Silhouette
Keywords
Joint, Pain
Summary

This study is to assess the effectiveness of a study medication not approved by the FDA for this use FX006 (Zilretta) on pain, disability, function, and global impression of change in patients who are 35 to 80 years of age who have been diagnosed with glenohumeral osteoarthritis of the shoulder or shoulder adhesive capsulitis. Glenohumeral osteoarthritis (shoulder arthritis) is the most common form of arthritis to affect the shoulder joint. Adhesive capsulitis (frozen shoulder) is a painful and disabling disorder of unclear cause in which the shoulder capsule, the tissue surrounding the joint of the shoulder, becomes inflamed and stiff, greatly restricting motion and causing chronic pain. Zilretta has only been approved by the Federal Drug Administration to treat patients with osteoarthritis of the knee. Subjects who qualify for all of the study criteria will receive an injection using a needle that is guided by an ultrasound and is put into the shoulder joint of either FX006 or placebo (a saline injection) in their effected shoulder and will come to the clinic to be seen for 7 follow up study visits for 24 weeks after the injection. There are a total of 9 clinic visits throughout the study and subjects will also complete an electronic study diary daily to assess shoulder pain and function.

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

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

List of Studies

Silhouette
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

Change_preferences

-- OR --

Create_login