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Outcomes Study of the Trabecular Metal (TM) Reverse Shoulder System

Active Not RecruitingN/A

Sponsor: Zimmer Biomet

Conditions: Osteoarthritis, Rheumatoid Arthritis, Post-traumatic Arthritis, Ununited Humeral Head Fracture, Irreducible 3-and 4-part Proximal Humeral Fractures

Interventions: Trabecular Metal Reverse Shoulder System

Countries: United States, United Kingdom

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

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.

Locations (5)

San Francisco, California, United States
Louisville, Kentucky, United States
Egg Harbor, New Jersey, United States
Philadelphia, Pennsylvania, United States
Blackburn, Lancashire, United Kingdom