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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1
Spine Institute of Louisiana
Shreveport, Louisiana, United States, 71101