Clinical Evaluation of the Integra® Titan™ Modular Shoulder System Generation 2.5 for Primary Shoulder Joint Replacement
Study Details
Study Description
Brief Summary
A post market, prospective, non-randomized, multi-center, open-label, clinical study using survivorship as the reference performance goal to study the safety and efficacy of the Titan Modular Shoulder System 2.5 when used for primary shoulder arthroplasty.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Integra Titan Modular Shoulder System 2.5
|
Device: Integra Titan Modular Shoulder System 2.5
Primary Shoulder Joint Replacement
|
Outcome Measures
Primary Outcome Measures
- Implant Survivorship [2 years]
Implant survivorship defined as absence of device removal or revision
Secondary Outcome Measures
- Implant Survivorship [1,5 and 10 years]
Implant survivorship defined as absence of device removal or revision
- Relative change of Range of Motion (ROM) compared to baseline [up to 10 years]
Relative change of ROM compared to baseline
- Relative change of Constant-Murley Score (CMS) compared to baseline [up to 10 years]
Relative change of CMS compared to baseline
- Relative change of American Shoulder & Elbow Surgeons Score (ASES) compared to baseline [up to 10 years]
Relative change of ASES compared to baseline
- Relative change of Single Assessment Numeric Evaluation (SANE) compared to baseline [up to 10 years]
Relative change of SANE compared to baseline
- Relative change of Simple Shoulder Test (SST) compared to baseline [up to 10 years]
Relative change of SST compared to baseline
- Relative change of Pain compared to baseline [up to 10 years]
Relative change of Visual Analogue Scale (VAS) Pain compared to baseline
Eligibility Criteria
Criteria
Inclusion Criteria:
- For total shoulder arthroplasty, subjects must meet a, b, or c below:
-
Severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis
-
Fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory
-
Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. -revision of a failed primary component)
- For shoulder hemiarthroplasty, subjects must meet any of the sub-criteria a - g below:
-
Severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis
-
Fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory
-
Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. -revision of a failed primary component)
-
Ununited humeral head fractures
-
Avascular necrosis of the humeral head
-
Rotator cuff arthropathy
-
Deformity and/or limited motion
Exclusion Criteria:
-
Absent, irreparable or nonfunctional rotator cuff or other essential muscles.
-
Have an active local or systemic infection.
-
Have inadequate bone stock in the proximal humerus or glenoid fossa for supporting the components.
-
Have 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.
-
Have a muscular, neurologic, or vascular deficiencies that compromise the affected extremity.
-
Have a known sensitivity or allergic reaction to one or more of the implanted materials.
-
Have a condition that may impair proper wound healing.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Alabama at Birmingham | Birmingham | Alabama | United States | 35294-0111 |
| 2 | John Hopkins University | Columbia | Maryland | United States | 21044 |
| 3 | Mississipi Bone and Joint Clinic | Starkville | Mississippi | United States | 39759 |
| 4 | The Research Foundation for The State University of New York (SUNY) | Syracuse | New York | United States | 13210 |
| 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 | University of Virginia Health System | Charlottesville | Virginia | United States | 22911 |
Sponsors and Collaborators
- Smith & Nephew, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- T-TSS-003