Sidus Stem-Free Shoulder IDE Study (NCT01878253) | Clinical Trial Compass
CompletedNot Applicable
Sidus Stem-Free Shoulder IDE Study
United States95 participantsStarted 2013-07
Plain-language summary
The purpose of this study is to determine if Sidus stem-free shoulder system is safe and effective when used in total shoulder replacement.
Who can participate
Age range22 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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…
What they're measuring
1
Pain and Function as Measured by the American Society of Shoulder and Elbow Surgeons Questionnaire
Timeframe: Two years
2
Absence of Radiographic Evidence of Failure or Pending Failure Based on Radiographic Assessment
Timeframe: Two years
3
The Number of Device Related Serious Adverse Events.