TITAN™ Reverse Shoulder System

Last updated: September 3, 2025
Sponsor: Smith & Nephew, Inc.
Overall Status: Terminated

Phase

N/A

Condition

Osteoarthritis

Bone Neoplasm

Rheumatoid Arthritis

Treatment

TITAN™ Reverse Shoulder System (TRS)

Clinical Study ID

NCT02204228
CP-0960-001
  • Ages > 21
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subjects with grossly deficient rotator cuff with severe arthropathy or Subjectswith failed joint replacement with grossly deficient rotator cuff

  • Subjects with a shoulder joint anatomically and structurally suited to receive thedevice

  • 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 theInformed Consent Form)

Exclusion

Exclusion Criteria:

  • 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 forsupporting the components

  • Subjects with poor bone quality such as osteoporosis where there could beconsiderable migration of the prosthesis and/or a chance of fracture of the humerusor glenoid

  • Subjects with muscular, neurologic, or vascular deficiencies that compromise theaffected extremity

  • Subjects with known metal allergies

  • Subjects are known to be at risk for lost to follow-up, or failure to return forscheduled visits

  • Subjects who are prisoners

  • Female subject who are pregnant, nursing, or of childbearing potential while notpracticing effective contraceptive methods

Study Design

Total Participants: 151
Treatment Group(s): 1
Primary Treatment: TITAN™ Reverse Shoulder System (TRS)
Phase:
Study Start date:
September 01, 2014
Estimated Completion Date:
December 14, 2023

Connect with a study center

  • Clinique Bizet

    Paris,
    France

    Site Not Available

  • Clinique Bizet

    Paris 2988507,
    France

    Site Not Available

  • Hospital de Manacor - Llevant

    Manacor, 07500
    Spain

    Site Not Available

  • Hospital de Manacor - Llevant

    Manacor 2514216, 07500
    Spain

    Site Not Available

  • Barts Health NHS Trust

    London,
    United Kingdom

    Site Not Available

  • Barts Health NHS Trust

    London 2643743,
    United Kingdom

    Site Not Available

  • University of Florida

    Gainesville, Florida 32607
    United States

    Site Not Available

  • University of Florida

    Gainesville 4156404, Florida 4155751 32607
    United States

    Site Not Available

  • Johns Hopkins University

    Columbia, Maryland 21044
    United States

    Site Not Available

  • Johns Hopkins University

    Columbia 4352053, Maryland 4361885 21044
    United States

    Site Not Available

  • Mississipi Bone and Joint Clinic

    Starkville, Mississippi 39759
    United States

    Site Not Available

  • Mississipi Bone and Joint Clinic

    Starkville 4447161, Mississippi 4436296 39759
    United States

    Site Not Available

  • Active Orthopedics

    Glen Ridge, New Jersey 07028
    United States

    Site Not Available

  • Active Orthopedics

    Glen Ridge 5098430, New Jersey 5101760 07028
    United States

    Site Not Available

  • The Orthopedics Foundation

    New Albany, Ohio 43054
    United States

    Site Not Available

  • Westphal Orthopaedics

    Lancaster, Pennsylvania 17601
    United States

    Site Not Available

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • The Rothman Institute

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • Westphal Orthopaedics

    Lancaster 5197079, Pennsylvania 6254927 17601
    United States

    Site Not Available

  • Hospital of the University of Pennsylvania

    Philadelphia 4560349, Pennsylvania 6254927 19104
    United States

    Site Not Available

  • The Rothman Institute

    Philadelphia 4560349, Pennsylvania 6254927 19107
    United States

    Site Not Available

  • University of Virginia Health

    Charlottesville, Virginia 22911
    United States

    Site Not Available

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