NCT02412397

Brief Summary

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

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 6, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 9, 2015

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Last Updated

April 9, 2015

Status Verified

April 1, 2015

First QC Date

April 6, 2015

Last Update Submit

April 8, 2015

Conditions

Osteoarthritis

Keywords

Shoulder

Outcome Measures

Primary Outcomes (1)

  • Implant Survivorship

    10 years post-operative

Interventions

Total Shoulder ArthroplastyPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients who were implanted with the DePuy Global Unite Shoulder System

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Osteoarthritis

Interventions

Arthroplasty, Replacement, Shoulder

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 6, 2015

First Posted

April 9, 2015

Primary Completion

December 1, 2020

Last Updated

April 9, 2015

Record last verified: 2015-04