Integra Titan Modular Shoulder System 2.5

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.


Inclusion Criteria

  • Subjects with grossly deficient rotator cuff with severe arthropathy or Subjects with failed joint replacement with grossly deficient rotator cuff
  • Subjects with a shoulder joint anatomically and structurally suited to receive the device
  • Subjects at least 21 years of age and skeletally mature at the time of surgery
  • Subject provided consent to participate in the clinical study (having signed the Informed Consent Form)
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Study Location(s)

Beverly

More about this Clinical Trial

Full Title

A POST-MARKET, PROSPECTIVE, NON-RANDOMIZED, MULTI-CENTER, OPEN-LABEL CLINICAL EVALUATION OF THE INTEGRA® TITAN MODULAR SHOULDER SYSTEM 2.5 FOR PRIMARY SHOULDER JOINT REPLACEMENT

Details
Disease Type/Condition

Orthopaedics

Principal Investigator

Stone, Michael

Age Group

Adult

Phase

IV

IRB Number

STUDY00000489

ClinicalTrials.gov ID

NCT02204228

Key Eligibility
ClinicalTrials.gov

Contact
Phone
310-423-6252
Email
clinicaltrials@cshs.org
Want to join the study or
learn more?

Details
Disease Type/Condition

Orthopaedics

Principal Investigator

Stone, Michael

Age Group

Adult

Phase

IV

IRB Number

T-TSS-003

ClinicalTrials.gov ID

NCT02204228

Key Eligibility
ClinicalTrials.gov

Contact
Phone
310-423-6252
Email
clinicaltrials@cshs.org
Want to join the study or
learn more?