Tornier Blueprint Planning Software in Patients Receiving Reverse Shoulder Arthroplasty

Spine Institute of Louisiana

Status: Unknown

Conditions: Reverse Shoulder Replacement

Treatments: Device: Reverse shoulder arthroplasty utilizing Blueprint Software

Study type: Interventional

Funder types: Industry

Identifiers

NCT04474665

Blueprint-2019

Details and patient eligibility

About

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

Full 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 accurate measurements of the glenoid version and inclination measurements in shoulder replacement surgery.

Pre-operative planning with Blueprint can accurately predict intraoperative implant selection within one size. Also, pre-operative planning leads to case efficiency and improved functional outcomes at 6 months post-operative compared to Baseline.

The objective of this study is to characterize implant size accuracy, planning time, functional outcomes, and procedural time (i.e., surgical time) using Blueprint planning software in subjects who are candidates for reverse shoulder arthroplasty.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. Previous bony surgery on the operative shoulder.
2. Shoulder pain due to acute trauma.
3. 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.)
4. Any active malignancy, infectious process, or documented chronic autoimmune disease.
5. Any other concurrent medical disease or treatment that might impair normal healing process.
6. Recent history (within past 6 months) of any chemical or alcohol dependence.
7. Currently a prisoner.
8. Currently experiencing a major mental illness (psychosis, schizophrenia, major affective disorder) which may indicate that the symptoms are psychological rather than of physical origin.
9. Pregnant or planning to become pregnant within study duration.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Implant placement accuracy

Other group

Description:

Blueprint planning software will be used to plan reverse shoulder replacement surgery. Accuracy of the placement compared to the plan will be assessed post-surgery.

Treatment:

Device: Reverse shoulder arthroplasty utilizing Blueprint Software