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NCT02412397 Clinical Trial

DePuy Global Unite Shoulder System

Osteoarthritis Clinical Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT02412397
Other study ID # 15Jabb
Secondary ID
Status Enrolling by invitation
Phase N/A
First received April 6, 2015
Last updated April 8, 2015

Study information
Verified date April 2015
Source Rothman Institute Orthopaedics
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 80
Est. completion date
Est. primary completion date December 2020
Accepts healthy volunteers
Gender Both
Age group 18 Years and older
Eligibility 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

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Intervention

Procedure:
• Total Shoulder Arthroplasty

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Rothman Institute Orthopaedics

Outcome
Type Measure Description Time frame Safety issue
Primary Implant Survivorship 10 years post-operative Yes
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