Clinical Evaluation of the TITAN™ Total Shoulder System
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ClinicalTrials.gov Identifier: NCT03245320 |
Recruitment Status :
Active, not recruiting
First Posted : August 10, 2017
Last Update Posted : February 9, 2022
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Condition or disease | Intervention/treatment |
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Arthritis Arthritis, Degenerative Rheumatoid Arthritis Post-traumatic Arthrosis of Other Joints, Shoulder Region Rotator Cuff Syndrome of Shoulder and Allied Disorders Fracture Avascular Necrosis Joint Instability Joint Trauma Dislocation, Shoulder Pain, Shoulder | Device: Integra TITAN™ Total Shoulder Generation 1.0 |
Study Type : | Observational |
Actual Enrollment : | 50 participants |
Observational Model: | Case-Control |
Time Perspective: | Other |
Official Title: | A Post-Market Observational Study to Evaluate Performance and Safety of the TITAN™ Total Shoulder System |
Actual Study Start Date : | March 20, 2017 |
Estimated Primary Completion Date : | June 2026 |
Estimated Study Completion Date : | June 2028 |
Group/Cohort | Intervention/treatment |
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TITAN™ Total Shoulder System Generation 1.0
Integra TITAN™ Total Shoulder System Generation 1.0
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Device: Integra TITAN™ Total Shoulder Generation 1.0
Total Shoulder Arthroplasty or Hemiarthroplasty |
- Implant survival at 2 years [ Time Frame: 2 years ]Implant survivorship is defined as absence of device removal or revision of one or more of the implant component(s).
- Implant survival . [ Time Frame: 5 and 10 years ]Implant survivorship is defined as absence of device removal or revision of one or more of the implant component(s).
- Relative change of Range of Motion (ROM) compared to baseline [ Time Frame: 2, 5, and 10 years ]Relative change of Range of Motion (ROM) compared to baseline
- Radiographic assessment [ Time Frame: 2, 5, and 10 years ]Radiographic assessment for loosening, malpositioned implant, subsidence, subluxation, and radiolucency
- Relative change in Quality Of Life (EQ-5D) compared to baseline [ Time Frame: 2, 5, and 10 years ]Relative change in Quality Of Life (EQ-5D) compared to baseline
- Relative change of American Shoulder and Elbow Surgeon Score (ASES) compared to baseline [ Time Frame: 2, 5, and 10 years ]Relative change of American Shoulder and Elbow Surgeon Score (ASES) compared to baseline
- Relative change of PENN Pain and Function Score (PENN) compared to baseline [ Time Frame: 2, 5, and 10 years ]Relative change of PENN Pain and Function Score (PENN) compared to baseline
- Relative change in Quality Of Life (SF-12V1) compared to baseline [ Time Frame: 2, 5, and 10 years ]Relative change in Quality Of Life (SF-12V1) compared to baseline

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Subject has undergone shoulder arthroplasty with the first generation TITAN Total Shoulder System.
- The first generation TITAN Total Shoulder System is still intact and the subject has not received any revision surgeries involving the TITAN Total Shoulder System.
- Subject is willing and able to participate in required follow-up visits at the investigational site and to complete study procedures.
Exclusion Criteria:
- Subject, in the opinion of the PI, has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study such as mental illness, or drug or alcohol abuse.
- Subject is known to be at risk for lost to follow-up, or failure to return for scheduled visits.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03245320
United States, Indiana | |
OrthoIndy | |
Indianapolis, Indiana, United States, 46278 | |
United States, Pennsylvania | |
The Rothman Institute | |
Philadelphia, Pennsylvania, United States, 19107 |
Study Director: | Andrew Tummon | Integra LifeSciences |
Responsible Party: | Smith & Nephew, Inc. |
ClinicalTrials.gov Identifier: | NCT03245320 |
Other Study ID Numbers: |
T-TSS-002 |
First Posted: | August 10, 2017 Key Record Dates |
Last Update Posted: | February 9, 2022 |
Last Verified: | February 2022 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Arthritis Osteoarthritis Joint Instability Shoulder Pain Shoulder Dislocation Necrosis Joint Diseases Musculoskeletal Diseases |
Rheumatic Diseases Pathologic Processes Joint Dislocations Wounds and Injuries Arthralgia Pain Neurologic Manifestations Shoulder Injuries |