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 Type
OBSERVATIONAL
Enrollment
151
All patients will be operated on with the TITAN™ Reverse Shoulder System (TRS).
University of Florida
Gainesville, Florida, United States
Johns Hopkins University
Columbia, Maryland, United States
Mississipi Bone and Joint Clinic
Starkville, Mississippi, United States
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.
Time frame: 2 Year
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
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
Relative change of EQ-5D score compared to baseline
Time frame: 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
Time frame: 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
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).
Relative change of Pain Visual Analog Scale (VAS) compared to baseline
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)
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Active Orthopedics
Glen Ridge, New Jersey, United States
Westphal Orthopaedics
Lancaster, Pennsylvania, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
The Rothman Institute
Philadelphia, Pennsylvania, United States
Clinique Bizet
Paris, France
Hospital de Manacor - Llevant
Manacor, Spain
Barts Health NHS Trust
London, United Kingdom
Relative change of SANE compared to baseline
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 5 Year/7 Year/10 Year