TITAN™ Reverse Shoulder System
- Conditions
- Osteoarthritis of the Shoulder
- Interventions
- Device: TITAN™ Reverse Shoulder System (TRS)
- Registration Number
- NCT02204228
- Lead Sponsor
- Smith & Nephew, Inc.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- SUSPENDED
- Sex
- All
- Target Recruitment
- 151
- 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)
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description TITAN™ Reverse Shoulder System (TRS) TITAN™ Reverse Shoulder System (TRS) TITAN™ Reverse Shoulder System (TRS) is a semi-constrained total shoulder construct.
- Primary Outcome Measures
Name Time Method Survival (lack of implant component removal or revision) 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.
- Secondary Outcome Measures
Name Time Method Efficacy assessed by comparing clinical results after surgery as measured with American Shoulder and Elbow Surgeons Score (ASES) 2 Year/5 Year/ 7Year/ 10 Year Relative change of ASES compared to baseline
Efficacy assessed by comparing clinical results after surgery as measured with Range of motion (ROM) 2 Year/5 Year/ 7Year/ 10 Year Relative change of ROM compared to baseline
Efficacy assessed by comparing clinical results after surgery as measured with EuroQOL-5 Dimension (EQ-5D) score 2 Year/5 Year/ 7Year/ 10 Year Relative change of EQ-5D score compared to baseline
Efficacy assessed by comparing clinical results after surgery as measured with Constant score. 2 Year/5 Year/ 7Year/ 10 Year Relative change of Constant score compared to baseline
Lack of unanticipated device related serious adverse events. 2 Year/5 Year/ 7Year/ 10 Year 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.
Survival (lack of implant component removal or revision) 5 Year/7 Year/10 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.
Efficacy assessed by comparing clinical results after surgery as measured with Pain Visual Analog Scale (VAS). 2 Year/5 Year/ 7Year/ 10 Year Relative change of Pain Visual Analog Scale (VAS) compared to baseline
Efficacy assessed by comparing clinical results after surgery as measured with Radiographs 2 Year/5 Year/ 7Year/ 10 Year Outcome after surgery will be evaluated using the Radiographs and comparison with pre-operative data.
Efficacy assessed by comparing clinical results after surgery as measured with SANE (Single Assessment Numeric Evaluation) 2 Year/5 Year/ 7Year/ 10 Year Relative change of SANE compared to baseline
Trial Locations
- Locations (10)
University of Florida
🇺🇸Gainesville, Florida, United States
Mississipi Bone and Joint Clinic
🇺🇸Starkville, Mississippi, United States
Active Orthopedics
🇺🇸Glen Ridge, New Jersey, United States
Hospital de Manacor - Llevant
🇪🇸Manacor, Spain
Barts Health NHS Trust
🇬🇧London, United Kingdom
Clinique Bizet
🇫🇷Paris, France
Johns Hopkins University
🇺🇸Columbia, Maryland, United States
The Rothman Institute
🇺🇸Philadelphia, Pennsylvania, United States
Hospital of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Westphal Orthopaedics
🇺🇸Lancaster, Pennsylvania, United States