TITAN™ Reverse Shoulder System

March 11, 2026 updated by: Smith & Nephew, Inc.

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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
151

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Survival (lack of implant component removal or revision)
Time Frame: 2 Year
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Efficacy assessed by comparing clinical results after surgery as measured with American Shoulder and Elbow Surgeons Score (ASES)
Time Frame: 2 Year/5 Year/ 7Year/ 10 Year
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
Time Frame: 2 Year/5 Year/ 7Year/ 10 Year
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)
Time Frame: 2 Year/5 Year/ 7Year/ 10 Year
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.
Time Frame: 2 Year/5 Year/ 7Year/ 10 Year
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).
Time Frame: 2 Year/5 Year/ 7Year/ 10 Year
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)
Time Frame: 2 Year/5 Year/ 7Year/ 10 Year
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
Time Frame: 2 Year/5 Year/ 7Year/ 10 Year
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.
Time Frame: 2 Year/5 Year/ 7Year/ 10 Year
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)
Time Frame: 5 Year/7 Year/10 Year
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Smith & Nephew, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Karlie Morgan, Smith & Nephew, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 14, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 14, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 21, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 28, 2014

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 30, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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