Sidus Stem-Free Shoulder IDE Study

Completed · Not applicable

Conditions studied: Osteoarthritis, Posttraumatic Arthrosis, Rheumatoid Arthritis

In brief

The purpose of this study is to determine if Sidus stem-free shoulder system is safe and effective when used in total shoulder replacement.

Key facts

Study ID: NCT01878253
Run by: Zimmer Biomet
People needed: 95
Starts: 2013-07-01
Expected to finish: 2019-01-01
Last updated by the study team: 2019-07-15

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patient must be 22 years of age or older.
Patient is skeletally mature.
Patient must have signed the IRB/EC approved informed consent.
Patient is a candidate for a total shoulder arthroplasty (replacement of humeral head and glenoid).
Patient has a diagnosis of primary osteoarthritis of the shoulder of grade III or higher.
Patient has experienced symptoms of shoulder pain and/or loss of function for at least 6 months and has a maximum ASES score of 40.
Patient has no findings to indicate an etiology of acute trauma, infection, avascular necrosis or inflammatory arthropathy of the operative shoulder.
Patient has undergone no previous reconstructive shoulder surgery. Acceptable previous shoulder surgeries include arthroscopy, soft tissue repair, or pinning/screw fixation due to a historic fracture.
Patient is willing and able to comply with the required post-operative therapy as defined in the protocol.
Patient is willing and able to comply with the required follow-up schedule as defined in the protocol.

You may not qualify if…

Patient is a prisoner.
Patient is a known current alcohol or drug abuser.
Patient has a psychiatric illness or cognitive deficit that precluded informed consent.
Patient has a chronic renal impairment or failure.
Patient sensitivity to implant materials.
Patient has a vascular insufficiency due to large or small vessel disease which could inhibit postoperative healing.
Patient is currently receiving or has received within the last 3 months chronic systemic or inhaled steroids. This exclusion does not apply to those patients with occasional inhaler use due to seasonal allergies.
Local rash or skin infection around the intended operative site.
Patients with ongoing Worker's Compensation or third party liability claims related to the operative shoulder.
Pre-existing contra-lateral shoulder replacement less than 6 months ago.
Patient who will require a contra-lateral shoulder replacement less than 6 months from the current planned shoulder replacement.
Patient has evidence of major joint trauma, infection, avascular necrosis, cuff tear arthropathy, chronic dislocation, massive rotator cuff tear, inflammatory arthropathy, or previous shoulder surgery (other than arthroscopy, soft tissue repair, or pinning/screw fixation due to historic fracture).
Patient has significant muscle paralysis.
Patient has Charcot arthropathy.
Patient has metaphyseal bony defects at the bone/implant interface which could inhibit prosthesis fixation.
Patient has a preoperative computed tomography scans or other radiographic images of the shoulder that showed insufficient glenoid or humeral bone stock to allow for implantation of the prosthesis.
Insufficient bone stock exists in the presence of metabolic bone disease (i.e. osteoporosis or severe osteopenia), cancer and radiation.
Patient with severe glenoid deficiency.
Prior fracture of the operative shoulder with the presence of malunion or non-union.
Prior tuberosity fracture with the presence of malunion or non-union.
Patient has an active joint or systemic infection.
Patient has a life expectancy of less than two years.
Patient with unacceptably high operative risk.
Patient unwilling to sign protocol required informed consent.
Patient is unwilling to complete the protocol required radiographic imaging.

Where it is running

Stanford University — Redwood City, California, United States
University of California San Francisco - Orthopaedics Institute — San Francisco, California, United States
St. Joseph's Hospital of Atlanta — Atlanta, Georgia, United States
Norton Orthopaedic & Sports Medicine — Louisville, Kentucky, United States
MedStar Health — Baltimore, Maryland, United States
Washington University — St Louis, Missouri, United States
Penn State Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States
Rothman Institute — Philadelphia, Pennsylvania, United States
University of Calgary Sports Medicine Clinic — Calgary, Alberta, Canada
Kingston General Hospital — Kingston, Ontario, Canada
St. Joseph's Health Care London - Hand and Upper Limb Centre — London, Ontario, Canada

Full record on ClinicalTrials.gov

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