DePuy Global Unite Shoulder System

• Conditions: Osteoarthritis

• Registration Number: NCT02412397
• Lead Sponsor: Rothman Institute Orthopaedics

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2015-04
• Study First Submitted: 2015-04-06
• Study First Submitted QC: 2015-04-08
• Last Update Submitted: 2015-04-08
• Study First Posted: 2015-04-09
• Last Update Posted: 2015-04-09
• Primary Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Implant Survivorship	10 years post-operative