TerminatedNo phase
TITAN™ Reverse Shoulder System
Key facts
- Who runs it
- Smith & Nephew, Inc.
- Where
- Columbia, Gainesville, Glen Ridge, Lancaster, Philadelphia, and Starkville, United StatesSee the 7 sitesAlso in 3 other countries, 3 sites
- Trial code
- Status
- Terminated
- People taking part
- 151 people enrolled
- Started
- Sept 2014
- Ended
- 14 Dec 2023
- Type of study
- Observational
- Treatments tested
- TITAN™ Reverse Shoulder System (TRS)
- Record updated
- 13 March 2026
- Why it stopped
- Business reasons not related to safety
Who can take part
- Age
- 21 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 13 criteriaShow less
Who can take part
- 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)
Who cannot take part
- Subjects with active local or systemic infection
- 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 without a functional deltoid muscle
- 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 who are prisoners
- Female subject who are pregnant, nursing, or of childbearing potential while not practicing effective contraceptive methods
Where in United States
Also in 3 other countries, 3 sites
- Johns Hopkins UniversityColumbia, United StatesNo longer taking part
- University of FloridaGainesville, United StatesNo longer taking part
- Active OrthopedicsGlen Ridge, United StatesNo longer taking part
- Westphal OrthopaedicsLancaster, United StatesNo longer taking part
- Hospital of the University of PennsylvaniaPhiladelphia, United StatesNo longer taking part
- The Rothman InstitutePhiladelphia, United StatesNo longer taking part
- Mississipi Bone and Joint ClinicStarkville, United StatesNo longer taking part
About the trial
What the trial wants to find out
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.
The group in the trial
- TITAN™ Reverse Shoulder System (TRS)
TITAN™ Reverse Shoulder System (TRS) is a semi-constrained total shoulder construct.
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Post-market Clinical Follow-up Study of the TITAN™ Reverse Shoulder System Used in Primary or Revision Total Shoulder Arthroplasty
- Record updated
- 13 March 2026