TITAN™ Reverse Shoulder System (NCT02204228) | Clinical Trial Compass
TerminatedNot Applicable
TITAN™ Reverse Shoulder System
Stopped: Business reasons not related to safety
United States, France, Spain151 participantsStarted 2014-09
Plain-language 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.
Who can participate
Age range
21 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Survival (lack of implant component removal or revision)