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

Zimmer Biomet

Status: Active, not recruiting

Conditions: Osteoarthritis; Gross Rotator Cuff Deficiency; Irreducible 3-and 4-part Proximal Humeral Fractures; Ununited Humeral Head Fracture; Avascular Necrosis; Post-traumatic Arthritis; Revision Total Shoulder Arthroplasty; Rheumatoid Arthritis

Treatments: Device: Trabecular Metal Reverse Shoulder System

Study type: Observational

Funder types: Industry

Identifiers

NCT01480440

CMU2010-28E

Details and patient eligibility

About

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.

Full description

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. This will be done by analysis of standard scoring systems, radiographs and adverse event records. Data will be collected and analyzed to monitor pain, function, and survivorship and to confirm the performance of the Trabecular Metal Reverse Shoulder System.

Performance will be evaluated by monitoring the frequency and incidence of adverse events as well as by assessment of the overall pain and functional performances, survivorship, health status and radiographic parameters of all enrolled study subjects who receive the Trabecular metal Reverse Shoulder System.

Pain and functional performance will be measured using the American Shoulder and Elbow Surgeons (ASES) Shoulder Assessment and the Single Assessment Numeric Evaluation (SANE), survivorship will be based on removal or intended removal of the device, health status will be determined by evaluation of the Short Form Survey12 (SF-12) as well as Adverse Events (AEs) and radiographic parameters analysis of x-rays.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

200 participants in 1 patient group

Trabecular Metal Reverse Shoulder System

Description:

Patients requiring primary or revision reverse total shoulder arthroplasty who receive the Trabecular Metal Reverse Shoulder System

Treatment:

Device: Trabecular Metal Reverse Shoulder System