New shoulder implant tracked in 200 patients for pain and function
NCT ID NCT01480440
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study follows 200 adults getting a shoulder replacement with the Zimmer Trabecular Metal Reverse Shoulder System. It aims to see how long the implant lasts and how well it relieves pain and improves movement in people with conditions like arthritis, fractures, or failed prior replacements. The implant is not a cure but helps control disease and improve quality of life.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 200 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2011
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Each investigator will screen from his/her patients who suffer from osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, ununited humeral head fracture, irreduciable 3-and 4-part proximal humeral fractures, avascular necrosis, gross rotator cuff dificiency or failed total shoulder arthroplasty (both glenoid and humeral components require revision) who meet the inclusion/exclusion criteria stated in the protocol
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Norton Orthopaedic & Sports Medicine
Louisville, Kentucky, 40241, United States
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Royal Blackburn Hospital
Blackburn, Lancashire, BB2 3HH, United Kingdom
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The Rothman Institute
Egg Harbor, New Jersey, 08234, United States
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The Rothman Institute
Philadelphia, Pennsylvania, 19107, United States
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University of California, San Francisco
San Francisco, California, 94143, United States
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