Upstate Active Clinical Trials

Study Title:

A Randomized, Multi-Center, Prospective, Safety and Efficacy Study comparing the outcome of reverse total shoulder arthroplasty (RSA) with SMR Stemless reverse vs SMR Stemmed reverse.

What is the purpose of the study? (in Layman's terms, please describe the study)

The study objective is to evaluate the safety and effectiveness of SMR Stemless Reverse compared to
control device, in total shoulder arthroplasty.

Upstate Institutional Review Board (IRB) Number:

1642028

Study/Protocol ID:

S-34

Study Phase:

NA

Patient Age Group:

Adults

Principal Investigator:

Kevin J Setter, MD

What is involved if I participate?

• How long is the study?
  2 years
• Is transportation provided or reimbursed?
  No
• Is parking provided or reimbursed?
  No
• What tests and procedures are involved?
  CT scan is required pre-operatively (within the last 90 days) and again at the 24 month study visit. Standard of care x-rays will be done at each office visit. Participants will be required to complete self-assessment worksheets at the following intervals: screening visit, 3 month post op, 6 month post op, 12 month post op and 24 month post op.

Where will the study take place?

Upstate Bone and Joint Center
6620 Fly Road
Easy Syracuse, NY 13057

Other Information:

NA

ClinicalTrials.Gov ID:

NCT04697004

For more information about this trial go to ClinicalTrials.Gov

Who can I contact for more information?

Name: Kayla A Sweeney, BA
Phone: 315-464-8618
Email: [email protected]

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