TITAN™ Reverse Shoulder System

Stopped early

Conditions studied: Osteoarthritis of the Shoulder

In brief

The Integra® TITAN™ Reverse Shoulder System (TRS) is a semi-constrained total shoulder construct. When used under the conditions and purposes intended the TRS will relieve pain and restore some functional joint motion to the affected shoulder. The purpose of this study is to assess the short, mid and long term outcomes of the TITAN™ Reverse Shoulder System.

Key facts

Study ID

NCT02204228

Run by

Smith & Nephew, Inc.

People needed

151

Starts

2014-09-01

Expected to finish

2023-12-14

Last updated by the study team

2026-03-13

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• Subjects without a functional deltoid muscle
• Subjects with active local or systemic infection
• Subjects with inadequate bone stock in the proximal humerus or glenoid fossa for supporting the components
• Subjects with poor bone quality such as osteoporosis where there could be considerable migration of the prosthesis and/or a chance of fracture of the humerus or glenoid
• Subjects with muscular, neurologic, or vascular deficiencies that compromise the affected extremity
• Subjects with known metal allergies
• Subjects are known to be at risk for lost to follow-up, or failure to return for scheduled visits
• Subjects who are prisoners
• Female subject who are pregnant, nursing, or of childbearing potential while not practicing effective contraceptive methods

Where it is running

• University of Florida — Gainesville, Florida, United States
• Johns Hopkins University — Columbia, Maryland, United States
• Mississipi Bone and Joint Clinic — Starkville, Mississippi, United States
• Active Orthopedics — Glen Ridge, New Jersey, United States
• Westphal Orthopaedics — Lancaster, Pennsylvania, United States
• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
• The Rothman Institute — Philadelphia, Pennsylvania, United States
• Clinique Bizet — Paris, France
• Hospital de Manacor - Llevant — Manacor, Spain
• Barts Health NHS Trust — London, United Kingdom

Full record on ClinicalTrials.gov

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