TITAN™ Reverse Shoulder System

A Post-market Clinical Follow-up Study of the TITAN™ Reverse Shoulder System Used in Primary or Revision Total Shoulder Arthroplasty

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.

Study Overview

• Status: Terminated
• Conditions: Osteoarthritis of the Shoulder
• Intervention / Treatment: Device: TITAN™ Reverse Shoulder System (TRS)

• Study Type: Observational
• Enrollment (Actual): 151

Contacts and Locations

Study Locations

• France
  • Paris, France
    • Clinique Bizet
• Spain
  • Manacor, Spain, 07500
    • Hospital de Manacor - Llevant
• United Kingdom
  • London, United Kingdom
    • Barts Health NHS Trust
• United States
  • Florida
    • Gainesville, Florida, United States, 32607
      • University of Florida
  • Maryland
    • Columbia, Maryland, United States, 21044
      • Johns Hopkins University
  • Mississippi
    • Starkville, Mississippi, United States, 39759
      • Mississipi Bone and Joint Clinic
  • New Jersey
    • Glen Ridge, New Jersey, United States, 07028
      • Active Orthopedics
  • Pennsylvania
    • Lancaster, Pennsylvania, United States, 17601
      • Westphal Orthopaedics
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of the University of Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • The Rothman Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients who require reverse shoulder replacement due to the inclusions below.

Description

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)

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 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
TITAN™ Reverse Shoulder System (TRS); TITAN™ Reverse Shoulder System (TRS) is a semi-constrained total shoulder construct.	Device: TITAN™ Reverse Shoulder System (TRS); All patients will be operated on with the TITAN™ Reverse Shoulder System (TRS).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival (lack of implant component removal or revision)	Any implant revisions or device related adverse events must be reported as soon as the event is discovered. Assessment of adverse events will occur at each clinic visit.	2 Year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy assessed by comparing clinical results after surgery as measured with American Shoulder and Elbow Surgeons Score (ASES)	Relative change of ASES compared to baseline	2 Year/5 Year/ 7Year/ 10 Year
Efficacy assessed by comparing clinical results after surgery as measured with EuroQOL-5 Dimension (EQ-5D) score	Relative change of EQ-5D score compared to baseline	2 Year/5 Year/ 7Year/ 10 Year
Efficacy assessed by comparing clinical results after surgery as measured with Range of motion (ROM)	Relative change of ROM compared to baseline	2 Year/5 Year/ 7Year/ 10 Year
Efficacy assessed by comparing clinical results after surgery as measured with Constant score.	Relative change of Constant score compared to baseline	2 Year/5 Year/ 7Year/ 10 Year
Efficacy assessed by comparing clinical results after surgery as measured with Pain Visual Analog Scale (VAS).	Relative change of Pain Visual Analog Scale (VAS) compared to baseline	2 Year/5 Year/ 7Year/ 10 Year
Efficacy assessed by comparing clinical results after surgery as measured with SANE (Single Assessment Numeric Evaluation)	Relative change of SANE compared to baseline	2 Year/5 Year/ 7Year/ 10 Year
Efficacy assessed by comparing clinical results after surgery as measured with Radiographs	Outcome after surgery will be evaluated using the Radiographs and comparison with pre-operative data.	2 Year/5 Year/ 7Year/ 10 Year
Lack of unanticipated device related serious adverse events.	Any device related adverse events must be reported as soon as the event is discovered. Assessment of adverse events will occur at each clinic visit.	2 Year/5 Year/ 7Year/ 10 Year
Survival (lack of implant component removal or revision)	Any implant revisions or device related adverse events must be reported as soon as the event is discovered. Assessment of adverse events will occur at each clinic visit.	5 Year/7 Year/10 Year

Collaborators and Investigators

• Sponsor: Smith & Nephew, Inc.
• Investigators: Study Director: Karlie Morgan, Smith & Nephew, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2014
• Primary Completion (Actual): December 14, 2023
• Study Completion (Actual): December 14, 2023

Study Registration Dates

• First Submitted: July 21, 2014
• First Submitted That Met QC Criteria: July 28, 2014
• First Posted (Estimated): July 30, 2014

Study Record Updates

• Last Update Posted (Actual): March 13, 2026
• Last Update Submitted That Met QC Criteria: March 11, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: osteoarthritis; rheumatoid arthritis; avascular necrosis; post traumatic arthritis; severe fractures
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Wounds and Injuries; Pathologic Processes; Arthritis; Joint Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Necrosis; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Osteoarthritis; Fractures, Bone; Arthritis, Rheumatoid; Osteonecrosis
• Other Study ID Numbers: CP-0960-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No