DePuy Global Unite Shoulder System | NCT02412397 | Trialant
Unknown statusObservationalUpdated Apr 9, 2015
DePuy Global Unite Shoulder System
ClinicalTrials.gov ID
NCT02412397
Lead Sponsor
Rothman Institute OrthopaedicsOTHER
Overall Status
Unknown status
Study Type
Observational
Enrollment
80Estimated
Last Update Posted
Apr 9, 2015Estimated
Primary Completion Date
Dec 2020Estimated
Brief Summary
To collect medium to long-term survivorship implant outcomes on the DePuy Global Unite Shoulder System
Osteoarthritis
Total Shoulder Arthroplasty
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No data available
Eligibility Criteria
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