Clinical trial NCT04474665: Tornier Blueprint Planning Software in Patients Receiving Reverse Shoulder Arthroplasty
Official title: A Single-arm, Prospective Study of Tornier Blueprint Planning Software in Patients Receiving Reverse Shoulder Arthroplasty
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Reverse Shoulder Replacement
Lead sponsor: Spine Institute of Louisiana Foundation
Sponsor class: INDUSTRY
Collaborators: name: Stryker Trauma and Extremities
First posted: 2020-07-17
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Range of motion
timeFrame: 6 months
measure: Accuracy of sizing
timeFrame: Perioperative
measure: Time to plan/perform case
timeFrame: Pre-operative
measure: Time to plan/perform case
timeFrame: Perioperative
Secondary outcomes:
measure: American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES)
timeFrame: 12 weeks
measure: American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES)
timeFrame: 6 months
measure: Simple Shoulder Test (SST) Questionnaire
timeFrame: Pre-operative
measure: Simple Shoulder Test (SST) Questionnaire
timeFrame: 2 weeks
measure: Simple Shoulder Test (SST) Questionnaire
timeFrame: 6 weeks
measure: Simple Shoulder Test (SST) Questionnaire
timeFrame: 12 weeks
measure: Simple Shoulder Test (SST) Questionnaire
timeFrame: 6 months
measure: Patient Satisfaction
timeFrame: 12 weeks
measure: Patient Satisfaction
timeFrame: 6 months
Other outcomes:
Locations:
city: Shreveport
country: United States
facility: Spine Institute of Louisiana
state: Louisiana
Study officials:
affiliation: Orthopedics Specialists of Louisiana
name: David Googe, MD
role: PRINCIPAL_INVESTIGATOR
References: