Active, not recruiting
Observational
Outcomes Study of the Trabecular Metal (TM) Reverse Shoulder System
Condition(s) studied
OsteoarthritisRheumatoid ArthritisPost-traumatic ArthritisUnunited Humeral Head FractureIrreducible 3-and 4-part Proximal Humeral FracturesAvascular NecrosisGross Rotator Cuff DeficiencyRevision Total Shoulder Arthroplasty
Investigational drug(s) / intervention(s)
Trabecular Metal Reverse Shoulder System
Trabecular Metal Reverse Shoulder System: Trabecular Metal Reverse Shoulder System used in primary or revision total shoulder arthroplasty
Study summary
The objectives of this study are to obtain survival and outcome data on the Trabecular Metal Reverse Shoulder System when used in primary or revision reverse total shoulder arthroplasty.
Eligibility
Inclusion Criteria:
* Patient is \> 18 years of age;
* Patient is skeletally mature;
* Patient qualifies for primary or revision unilateral or bilateral reverse total shoulder arthroplasty based on physical exam and medical history including the following: osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, ununited humeral head fracture, irreducible 3-and 4-part proximal humeral fractures, avascular necrosis, gross rotator cuff deficiency or failed total shoulder arthroplasty (both glenoid and humeral components require revision);
* Patient is willing and able to provide written informed consent;
* Patient is willing and able to cooperate in the required post-operative therapy;
* Patient is willing and able to complete scheduled follow-up evaluations/questionnaires as described in the Informed Consent;
* Patient has participated in the Informed Consent process and has signed the Institutional Review Board (IRB)/Ethical Review Board (ERB) approved informed consent.
Exclusion Criteria:
* The patient is a prisoner;
* The patient is mentally incompetent or unable to understand what participation in the study entails;
* The patient is a known alcohol or drug abuser;
* The patient is anticipated to be non-compliant;
* The patient has one of the following compromising the affected limb: a significant injury to the upper brachial plexus, paralysis of the axillary nerve or a neuromuscular disease compromising the affected limb which would render the procedure unjustifiable;
* The patient has a local/systemic infection;
* The patient is known to be pregnant;
* The patient has marked bone loss;
* The patient has a known sensitivity or allergic reaction to one or more of the implanted materials;
* The patient is unwilling or unable to give consent or to comply with the follow-up program.
Primary outcome measure(s)
- Survivorship — 10 Years
Based on removal or intended removal of the device and determined using the Kaplan-Meier method.
Trial sites (5)
| Facility | City | Region | Status |
| University of California, San Francisco |
San Francisco |
California |
|
| Norton Orthopaedic & Sports Medicine |
Louisville |
Kentucky |
|
| The Rothman Institute |
Egg Harbor |
New Jersey |
|
| The Rothman Institute |
Philadelphia |
Pennsylvania |
|
| Royal Blackburn Hospital |
Blackburn |
Lancashire |
|
More Zimmer Biomet trials in the UK
Other trials for the same condition