Tornier Blueprint Planning Software in Patients Receiving Reverse Shoulder Arthroplasty

A Single-arm, Prospective Study of Tornier Blueprint Planning Software in Patients Receiving Reverse Shoulder Arthroplasty

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

Study Overview

• Status: Unknown
• Conditions: Reverse Shoulder Replacement
• Intervention / Treatment: Device: Reverse shoulder arthroplasty utilizing Blueprint Software

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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	Device: Reverse shoulder arthroplasty utilizing Blueprint Software; Reverse shoulder arthroplasty utilizing Blueprint Software

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Range of motion	Range of motion of the operative shoulder	6 months
Accuracy of sizing	Blueprint planned implant size compared to actual implant size	Perioperative
Time to plan/perform case	Time required for surgeon to plan and perform the case using the Bluerpint software	Pre-operative
Time to plan/perform case	Time required for surgeon to plan and perform the case using the Bluerpint software	Perioperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES)	Questionnaire to score and understand how well you function in everyday life, concerning your shoulder pain/limitations. 0-100 score, with higher score indicating higher functionality.	12 weeks
American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES)	Questionnaire to score and understand how well you function in everyday life, concerning your shoulder pain/limitations. 0-100 score, with higher score indicating higher functionality.	6 months
Simple Shoulder Test (SST) Questionnaire	12 yes/no questions to understand your daily functionality concerning your shoulder.	Pre-operative
Simple Shoulder Test (SST) Questionnaire	12 yes/no questions to understand your daily functionality concerning your shoulder.	2 weeks
Simple Shoulder Test (SST) Questionnaire	12 yes/no questions to understand your daily functionality concerning your shoulder.	6 weeks
Simple Shoulder Test (SST) Questionnaire	12 yes/no questions to understand your daily functionality concerning your shoulder.	12 weeks
Simple Shoulder Test (SST) Questionnaire	12 yes/no questions to understand your daily functionality concerning your shoulder.	6 months
Patient Satisfaction	Patient rated satisfaction with surgical treatment rated; very satisfied, somewhat satisfied, somewhat dissatisfied, or very dissatisfied	12 weeks
Patient Satisfaction	Patient rated satisfaction with surgical treatment rated; very satisfied, somewhat satisfied, somewhat dissatisfied, or very dissatisfied	6 months

Collaborators and Investigators

• Sponsor: Spine Institute of Louisiana Foundation
• Collaborators: Stryker Trauma GmbH
• Investigators: Principal Investigator: David Googe, MD, Orthopedics Specialists of Louisiana

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2020
• Primary Completion (Anticipated): June 1, 2021
• Study Completion (Anticipated): June 1, 2021

Study Registration Dates

• First Submitted: July 8, 2020
• First Submitted That Met QC Criteria: July 13, 2020
• First Posted (Actual): July 17, 2020

Study Record Updates

• Last Update Posted (Actual): July 17, 2020
• Last Update Submitted That Met QC Criteria: July 13, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: Blueprint-2019

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No