A Study to Evaluate Shoulder Anthroplasty Outcomes

Overview

About this study

The primary objective of this study is to collect and evaluate long-term clinical and radiographic outcomes data to better understand the safety and performance of shoulder arthroplasty over time.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Patient is indicated for shoulder arthroplasty (or has previously undergone shoulder arthroplasty).
  • Patient is at least 21 years of age. 
  • Patient is expected to survive at least 2 years beyond surgery.
  • Patient is willing to participate by complying with pre- and postoperative visit requirements.
  • Patient is willing and able to review and sign a study informed consent form.

Exclusion Criteria:

  • Osteomyelitis of the proximal humerus or scapula; if a systemic infection or a secondary remote infection is suspected or confirmed, implementation should be delayed until infection is resolved.
  •  Inadequate or malformed bone that precludes adequate support or fixation of the prosthesis.
  • Neuromuscular disorders that do not allow control of the joint.
  • Significant injury to the brachial plexus.
  • Non-functional deltoid muscles.
  • Patient’s age, weight, or activity level would cause the surgeon to expect early failure of the system.
  • The patient is unwilling or unable to comply with the post-operative care instructions.
  • Alcohol, drug, or other substance abuse.
  • Any disease state that could adversely affect the function or longevity of the implant.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Bradley Schoch, M.D.

Open for enrollment

Contact information:

Stephanie Giles

(904) 953-9406

Giles.Stephanie@mayo.edu

More information

Publications

Publications are currently not available
.

Mayo Clinic Footer