Outcomes Study of the TM Humeral Stem Used in Primary, Total or Hemi Shoulder Arthroplasty

Stopped early

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

In brief

The objectives of this study are to obtain survival and outcome data on the Trabecular Metal Humeral Stem when used in primary, total or hemi shoulder arthroplasty.

Key facts

Study ID

NCT01480453

Run by

Zimmer Biomet

People needed

67

Starts

2011-01-02

Expected to finish

2018-12-31

Last updated by the study team

2019-03-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient is >18 years of age;
• Patient is skeletally mature;
• Patient qualifies for primary unilateral or bilateral total or hemi 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
• 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 will 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 IRB/ERB approved informed consent;

You may not qualify if…

• 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.

Where it is running

• Norton Orthopaedic Specialists — Louisville, Kentucky, United States
• William Beaumont Hospital — Royal Oak, Michigan, United States
• The Rothman Institute — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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