TITAN™ Reverse Shoulder System
Status: | Recruiting |
---|---|
Conditions: | Osteoarthritis (OA) |
Therapuetic Areas: | Rheumatology |
Healthy: | No |
Age Range: | 21 - Any |
Updated: | 1/27/2019 |
Start Date: | September 2014 |
End Date: | September 2025 |
Contact: | Andrew Tummon |
Email: | andrew.tummon@integralife.com |
Phone: | 609-936-5490 |
A Post-market Clinical Follow-up Study of the TITAN™ Reverse Shoulder System Used in Primary or Revision Total Shoulder Arthroplasty
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.
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.
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
We found this trial at
9
sites
3400 Spruce St
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
(215) 662-4000
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