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New shoulder implant tested for severe arthritis – but study halted early

NCT ID NCT02204228

Disease control Sponsor: Smith & Nephew, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at the TITAN Reverse Shoulder System, a device used to replace the shoulder joint in people with severe arthritis and a torn rotator cuff. The goal was to see if it relieves pain and improves movement. About 151 people were planned to take part, but the study was stopped early, so the full results are not available.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
TITAN™ Reverse Shoulder System (a shoulder replacement device)
What this could lead to
If successful, this device could provide a reliable option for pain relief and improved shoulder function in patients with severe arthritis and a torn rotator cuff.
What could go wrong
The study was terminated early, so results are limited. As with any surgery, risks include infection, implant loosening, or nerve injury.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

151 people

The number who actually took part.

Started

Sep 2014

Finished

Dec 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

21 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

bone fracture osteoarthritis osteonecrosis rheumatoid arthritis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Osteoarthritis of the shoulder

Contacts and locations

Locations

  • Active Orthopedics

    Glen Ridge, New Jersey, 07028, United States

  • Barts Health NHS Trust

    London, United Kingdom

  • Clinique Bizet

    Paris, France

  • Hospital de Manacor - Llevant

    Manacor, 07500, Spain

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • Johns Hopkins University

    Columbia, Maryland, 21044, United States

  • Mississipi Bone and Joint Clinic

    Starkville, Mississippi, 39759, United States

  • The Rothman Institute

    Philadelphia, Pennsylvania, 19107, United States

  • University of Florida

    Gainesville, Florida, 32607, United States

  • Westphal Orthopaedics

    Lancaster, Pennsylvania, 17601, United States

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