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This investigation is a prospective, multi-center clinical investigation. It is anticipated that a total of one hundred (100) subjects will be enrolled at approximately 5-10 sites. The clinical investigation has been designed to follow the surgeon's standard of care for joint arthroplasty patients, which entails clinical evaluation on a regular ongoing basis, or as needed should the patient become symptomatic in the treated joint.
The objective of this clinical investigation is to demonstrate the safety and efficacy/performance of the ReUnion RFX System. Efficacy/performance of the procedure will be measured by the American Shoulder and Elbow Surgeons (ASES) Shoulder Score. Safety of the ReUnion RFX System will be demonstrated through reporting of device-related intraoperative and postoperative Adverse Events (AEs). Enrolled subjects will be assessed at Pre-Operative, Operative/Discharge, and at 6 Weeks, 6 Months, 12 Months, 24 Months and annually thereafter up to 10 years following the index procedure.
ReUnion Total Shoulder Arthroplasty (TSA), ReUnion Reverse Shoulder Arthroplasty (RSA)
Not yet recruiting
Stryker Trauma GmbH
Published on BioPortfolio: 2019-09-18T03:27:31-0400
The study will compare the outcome of primary reverse shoulder arthroplasty using the Stryker ReUnion System with implantation of either a large (40 mm) or a small (36 mm) glenosphere with...
This investigation is a prospective, multicenter clinical investigation. It is anticipated that a total of eighty (80) subjects will be enrolled at approximately 4-7 sites. The clinical in...
The purpose of this study is to evaluate reverse total shoulder arthroplasty patients preoperative objective measurements and operative objective measurements to determine if there is any ...
The goals of total, reverse total and hemi shoulder arthroplasty are the same, to alleviate the patient's pain and obtain a full functional recovery. This outcome depends on the surgeon's ...
This study is designed to answer if patients fair better with non-operative management or reverse total arthroplasty for treatment of 3- and 4-part proximal humerus fractures.
Rheumatoid arthritis has been associated with poor clinical outcomes in hemiarthroplasty and unconstrained total shoulder arthroplasty. The reverse shoulder arthroplasty can be utilized to address the...
As total joint arthroplasty (TJA) utilization increases, arthroplasties of multiple joints in a patient are more common. An understanding of the success of shoulder arthroplasty patients also requirin...
Comparison of Clinical Outcomes After Anatomic Total Shoulder Arthroplasty and Reverse Shoulder Arthroplasty in Patients 70 Years and Older With Glenohumeral Osteoarthritis and an Intact Rotator Cuff.
As the indications for reverse shoulder arthroplasty (RSA) expand beyond traditional cuff tear arthropathy, the role of RSA in elderly patients with glenohumeral arthritis and an intact rotator cuff r...
Success after glenoid bone augmentation in total shoulder arthroplasty depends on osseous integration and non-resorption. Standard imaging techniques, such as computed tomography (CT) and X-rays, cann...
Few studies have investigated the amount of blood loss during reverse total shoulder arthroplasty (RTSA). The purpose of this study was to investigate blood loss in patients who underwent RTSA for mas...
Replacement of the SHOULDER JOINT.
One of the Indian Ocean Islands, east of Madagascar. Its capital is Saint-Denis. It was discovered in 1507 by the Portuguese and claimed by France in 1638. It was first colonized in 1662 as Isle de Bourbon but renamed Reunion in 1793. In 1946 it was made an overseas department of France. The name commemorates the reunion of the revolutionaries from Marseilles with the National Guard in Paris in 1792. (From Webster's New Geographical Dictionary, 1988, p1011; Room, Brewer's Dictionary of Names, 1992, p454; French Embassy)
Replacement for a SHOULDER JOINT.
Also called the shoulder blade, it is a flat triangular bone, a pair of which form the back part of the shoulder girdle.
Partial or total replacement of a joint.
Arthritis Fibromyalgia Gout Lupus Rheumatic Rheumatology is the medical specialty concerned with the diagnosis and management of disease involving joints, tendons, muscles, ligaments and associated structures (Oxford Medical Diction...
Arthroplasty Joint Disorders Orthopedics Spinal Cord Disorders Orthopedics is the science or practice of correcting deformities caused by disease or damage to the bones and joints of the skeleton. This specialized branch of surgery may ...