TITAN™ Reverse Shoulder System
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| TITAN™ Reverse Shoulder System (TRS) TITAN™ Reverse Shoulder System (TRS) is a semi-constrained total shoulder construct. |
Device: TITAN™ Reverse Shoulder System (TRS)
All patients will be operated on with the TITAN™ Reverse Shoulder System (TRS).
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Outcome Measures
Primary Outcome Measures
- 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
- 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 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 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 Constant score. [2 Year/5 Year/ 7Year/ 10 Year]
Relative change of Constant score compared to baseline
- 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 SANE (Single Assessment Numeric Evaluation) [2 Year/5 Year/ 7Year/ 10 Year]
Relative change of SANE 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.
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Subjects with grossly deficient rotator cuff with severe arthropathy or Subjects with failed joint replacement with grossly deficient rotator cuff
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Subjects with a shoulder joint anatomically and structurally suited to receive the device
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Subjects at least 21 years of age and skeletally mature at the time of surgery
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Subject provided consent to participate in the clinical study (having signed the Informed Consent Form)
Exclusion Criteria:
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Subjects without a functional deltoid muscle
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Subjects with active local or systemic infection
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Subjects with inadequate bone stock in the proximal humerus or glenoid fossa for supporting the components
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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
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Subjects with muscular, neurologic, or vascular deficiencies that compromise the affected extremity
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Subjects with known metal allergies
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Subjects are known to be at risk for lost to follow-up, or failure to return for scheduled visits
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Subjects who are prisoners
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Female subject who are pregnant, nursing, or of childbearing potential while not practicing effective contraceptive methods
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Florida | Gainesville | Florida | United States | 32607 |
| 2 | Johns Hopkins University | Columbia | Maryland | United States | 21044 |
| 3 | Mississipi Bone and Joint Clinic | Starkville | Mississippi | United States | 39759 |
| 4 | Active Orthopedics | Glen Ridge | New Jersey | United States | 07028 |
| 5 | Westphal Orthopaedics | Lancaster | Pennsylvania | United States | 17601 |
| 6 | Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | United States | 19104 |
| 7 | The Rothman Institute | Philadelphia | Pennsylvania | United States | 19107 |
| 8 | Clinique Bizet | Paris | France | ||
| 9 | Hospital de Manacor - Llevant | Manacor | Spain | 07500 | |
| 10 | Barts Health NHS Trust | London | United Kingdom |
Sponsors and Collaborators
- Smith & Nephew, Inc.
Investigators
- Study Director: Derick Bermudez, Smith & Nephew, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CP-0960-001