Status:

UNKNOWN

Tornier Blueprint Planning Software in Patients Receiving Reverse Shoulder Arthroplasty

Lead Sponsor:

Spine Institute of Louisiana Foundation

Collaborating Sponsors:

Stryker Trauma and Extremities

Conditions:

Reverse Shoulder Replacement

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

Compare sizing determined in pre-operative planning of reverse shoulder arthroplasty to operative implant size selected.

Detailed Description

The Blueprint planning software automatically creates a virtual implantation environment for the surgeon to use. The use of 3D measurements is independent of patient positioning, which results in more...

Eligibility Criteria

Inclusion

  • Skeletally mature, and age ≥ 18 years.
  • In the opinion of the treating surgeon, must already be a qualified candidate for reverse shoulder arthroplasty without the use of glenoid bone grafts.
  • Be likely to return for regular follow-ups until the end of the study period.
  • Be willing and able to provide Informed Consent for study participation.

Exclusion

  • Previous bony surgery on the operative shoulder.
  • Shoulder pain due to acute trauma.
  • Clinical, laboratory and/or radiological evidence of shoulder pain secondary to acute or chronic infection, malignancy, other space occupying lesions and metabolic bone demineralization diseases (e.g. osteomalacia, gout, Paget's disease etc.)
  • Any active malignancy, infectious process, or documented chronic autoimmune disease.
  • Any other concurrent medical disease or treatment that might impair normal healing process.
  • Recent history (within past 6 months) of any chemical or alcohol dependence.
  • Currently a prisoner.
  • Currently experiencing a major mental illness (psychosis, schizophrenia, major affective disorder) which may indicate that the symptoms are psychological rather than of physical origin.
  • Pregnant or planning to become pregnant within study duration.

Key Trial Info

Start Date :

March 16 2020

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

June 1 2021

Estimated Enrollment :

20 Patients enrolled

Trial Details

Trial ID

NCT04474665

Start Date

March 16 2020

End Date

June 1 2021

Last Update

July 17 2020

Active Locations (1)

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Spine Institute of Louisiana

Shreveport, Louisiana, United States, 71101