Integra Titan Modular Shoulder System 2.5

Condition: Primary shoulder joint replacement surgery

Eligibility

Key Inclusion Criteria

  • At least 18 years old and skeletally mature
  • If a candidate for total shoulder arthroplasty, participants must meet specific subcriteria or if a hemiarthroplasty candidate, must meet specific subcriteria
  • Willing and able to complete scheduled follow-up visits, evaluations and questionnaires

Key Exclusion Criteria

  • Candidate for total shoulder arthroplasty and has absent, irreparable or nonfunctional rotator cuff or other essential muscles
  • Has an active local or systemic infection
  • Has inadequate bone stock in the proximal humerus or glenoid fossa for supporting the components

Full Study Name

A Post-Market, Prospective, Non-Randomized, Multicenter, Open-Label Clinical Evaluation of the Integra Titan Modular Shoulder System 2.5 for Primary Shoulder Joint Replacement (IRB no. 00000489) 

Summary

The purpose of this study is to evaluate the long-term performance and safety of a device called the Integra Titan Modular Shoulder System 2.5 for Primary Total Shoulder Joint Replacement (also called the “Titan 2.5”). The study focuses on individuals who have severely painful and/or disabled joints resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis, or who have serious fractures of the humerus (the long bone in the upper half of the arm) and will undergo primary shoulder replacement surgery using the Titan-2.5 as standard of care for their condition.

The Titan 2.5 is approved for shoulder replacement surgery by the U.S. Food and Drug Administration (FDA). It is designed to treat pain, limited motion, or weakness in the shoulder. The device works by replacing the diseased shoulder joint of patients.


Principal Investigator

Michael Stone, MD

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