Long Term Sidus PMCF

Withdrawn before enrolling · Not applicable

Conditions studied: Osteoarthritis, Post-traumatic; Arthrosis

In brief

The objectives of this study are to assess the safety and performance of the Sidus Stem-Free Shoulder Arthroplasty System in unilateral primary total shoulder arthroplasty.

Key facts

Study ID

NCT04063943

Run by

Zimmer Biomet

People needed

0

Starts

2019-07-12

Expected to finish

2020-03-31

Last updated by the study team

2021-05-13

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient must have previously participated in the Sidus IDE clinical trial.
• Patient must not have undergone revision of the Sidus shoulder.
• Patient must be able and willing to complete the protocol required follow-up.
• Patient must be able and willing to sign the IRB/EC approved informed consent.

You may not qualify if…

• Patient is a prisoner.
• Patient is a current alcohol or drug abuser.
• Uncooperative patient or patient with neurologic disorders who is incapable or unwilling to follow directions.
• Patient did not previously participate in the Sidus IDE clinical trial.
• Patient no longer has Sidus shoulder implanted.

Where it is running

• Norton Orthopaedic & Sports Medicine — Louisville, Kentucky, United States
• MedStar Health — Baltimore, Maryland, United States
• Rothman Institute — Philadelphia, Pennsylvania, United States
• The 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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