DePuy Global Unite Shoulder System

April 8, 2015 updated by: Rothman Institute Orthopaedics
To collect medium to long-term survivorship implant outcomes on the DePuy Global Unite Shoulder System

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

80

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients who were implanted with the DePuy Global Unite Shoulder System

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Implant Survivorship
Time Frame: 10 years post-operative
10 years post-operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rothman Institute Orthopaedics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Primary Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

April 6, 2015

First Submitted That Met QC Criteria

April 8, 2015

First Posted (Estimate)

April 9, 2015

Study Record Updates

Last Update Posted (Estimate)

April 9, 2015

Last Update Submitted That Met QC Criteria

April 8, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15Jabb

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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