Tornier Blueprint Planning Software in Patients Receiving Reverse Shoulder Arthroplasty

NCT ID: NCT04474665

Last Updated: 2020-07-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-16
• Study Completion Date: 2021-06-01

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 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.

Conditions

Reverse Shoulder Replacement

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Implant placement accuracy

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.

Group Type: OTHER

Reverse shoulder arthroplasty utilizing Blueprint Software

Intervention Type: DEVICE

Reverse shoulder arthroplasty utilizing Blueprint Software

Interventions

Reverse shoulder arthroplasty utilizing Blueprint Software

Reverse shoulder arthroplasty utilizing Blueprint Software

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Stryker Trauma and Extremities

INDUSTRY

Sponsor Role: collaborator

Spine Institute of Louisiana Foundation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Googe, MD

Role: PRINCIPAL_INVESTIGATOR

Orthopedics Specialists of Louisiana

Locations

Spine Institute of Louisiana

Shreveport, Louisiana, United States

Countries

United States

Other Identifiers

Blueprint-2019

Identifier Type: -

Identifier Source: org_study_id