DePuy Global Unite Shoulder System

NCT02412397 — Unknown, 80 participants, Rothman Institute Orthopaedics

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RegistryNCT02412397
StatusUnknown
Study typeObservational
Enrollment80 (Estimated)
SponsorRothman Institute Orthopaedics (Other)
ConditionsOsteoarthritis
InterventionsTotal Shoulder Arthroplasty (Procedure)
Datesprimary completion 2020-12-01 (estimated), first posted 2015-04-09, last updated 2015-04-09

Related Papers Related Patents Related Grants Related Experts
All trials for Osteoarthritis All trials of Total Shoulder Arthroplasty

-Summary

To collect medium to long-term survivorship implant outcomes on the DePuy Global Unite Shoulder System

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+Arms and interventions

  • Total Shoulder Arthroplasty (Procedure)

+Outcome measures

Primary outcomes

  • Implant Survivorship [10 years post-operative]

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Patient greater than 18 years of age and skeletally mature
* Patient qualifies for primary or revision total or reverse shoulder arthroplasty based on diagnosis of investigator of osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, un-united humeral head fractures, irreducible 3- and 4- part proximal humeral fracture, avascular necrosis, or gross rotator cuff deficiency.
* Patient is willing and able to provide written informed consent and to complete scheduled follow up visits/evaluations/questionnaires

Exclusion Criteria:

* Patient has one of the following compromise the affected limb; a significant injury to the upper brachial plexus, paralysis of the axillary nerve, or a neuromuscular disease compromising the affected limb
* Patient has a known or suspected infection
* Patient is known to be pregnant
* Patient has a sensitivity or allergic reaction to one or more of the implanted materials
* Patient is unwilling or unable to provide consent or comply with follow up visits