DePuy Global Unite Shoulder System

NCT ID: NCT02412397

Last Updated: 2015-04-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Brief Summary

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

Detailed Description

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Conditions

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Osteoarthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Interventions

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Total Shoulder Arthroplasty

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rothman Institute Orthopaedics

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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15Jabb

Identifier Type: -

Identifier Source: org_study_id

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