Osteoarthritis of the ShoulderNCT02204228
TITAN™ Reverse Shoulder System
An observational study of Osteoarthritis of the Shoulder, run by Smith & Nephew, Inc. at 10 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Osteoarthritis of the Shoulder
- What is being tested?
- TITAN™ Reverse Shoulder System (TRS)
- Type of treatment
- Medical device
- How many people
- 151 participants
- Where
- 10 sitesin 4 countries
- Study dates
- Sep 2014to 14 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who require reverse shoulder replacement due to the inclusions below.
Who may be able to join
- 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 join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
10 sites in 4 countries.
10 sites in 4 countries
United States7 sites
Johns Hopkins University
Columbia, Maryland, 21044
University of Florida
Gainesville, Florida, 32607
Active Orthopedics
Glen Ridge, New Jersey, 07028
Westphal Orthopaedics
Lancaster, Pennsylvania, 17601
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
The Rothman Institute
Philadelphia, Pennsylvania, 19107
Mississipi Bone and Joint Clinic
Starkville, Mississippi, 39759
About this study
Official title: 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.
- Conditions
- Osteoarthritis of the Shoulder
- Being tested
- TITAN™ Reverse Shoulder System (TRS)
- Keywords
- osteoarthritis, rheumatoid arthritis, post traumatic arthritis, avascular necrosis, severe fractures
- Medical subject headings
- Osteoarthritis, Arthritis, Rheumatoid, Osteonecrosis, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TITAN™ Reverse Shoulder System (TRS)Device
All patients will be operated on with the TITAN™ Reverse Shoulder System (TRS).
| Study group | Role | What they receive |
|---|---|---|
| TITAN™ Reverse Shoulder System (TRS) | TITAN™ Reverse Shoulder System (TRS) is a semi-constrained total shoulder construct. Receives: Device: TITAN™ Reverse Shoulder System (TRS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 Year
Secondary outcomes (9)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 5 Year/7 Year/10 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2014 (estimated)
- Study startSep 2014
- Primary completion14 Dec 2023
- Study completion14 Dec 2023
Why it stopped: Business reasons not related to safety
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis of the ShoulderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smith & Nephew, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Karlie Morgan, Study director, Smith & Nephew, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02204228
- Sponsor's protocol ID
- CP-0960-001
- Status last verified
- Mar 2026
- First submitted
- 21 Jul 2014
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post-market Clinical Follow-up Study of the TITAN™ Reverse Shoulder System Used in Primary or Revision Total Shoulder Arthroplasty
- ClinicalTrials.gov ID
- NCT02204228
- Acronym / sponsor ID
- CP-0960-001
- Conditions
- Osteoarthritis of the Shoulder
- Keywords
- osteoarthritis, rheumatoid arthritis, post traumatic arthritis, avascular necrosis, severe fractures
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Business reasons not related to safety
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Smith & Nephew, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2014 (actual)
- Primary completion
- 14 Dec 2023 (actual)
- Study completion
- 14 Dec 2023 (actual)
- First posted
- 30 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TITAN™ Reverse Shoulder System (TRS) | – | Device: TITAN™ Reverse Shoulder System (TRS)TITAN™ Reverse Shoulder System (TRS) is a semi-constrained total shoulder construct. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who require reverse shoulder replacement due to the inclusions below.
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TITAN™ Reverse Shoulder System (TRS)All patients will be operated on with the TITAN™ Reverse Shoulder System (TRS). | Device | TITAN™ Reverse Shoulder System (TRS) |
Primary outcome
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.
9 secondary outcomes
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
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
Efficacy assessed by comparing clinical results after surgery as measured with Range of motion (ROM)
Time frame: 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
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
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
Efficacy assessed by comparing clinical results after surgery as measured with Radiographs
Time frame: 2 Year/5 Year/ 7Year/ 10 Year
Lack of unanticipated device related serious adverse events.
Time frame: 2 Year/5 Year/ 7Year/ 10 Year
Survival (lack of implant component removal or revision)
Time frame: 5 Year/7 Year/10 Year
Results and safety
The study was stopped early (reason given: Business reasons not related to safety). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karlie Morgan study director
Smith & Nephew, Inc.
10 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis of the Shoulder, run by Smith & Nephew, Inc. at 10 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, France, Spain, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Business reasons not related to safety). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival (lack of implant component removal or revision) (time frame: 2 Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.