Tornier Blueprint Planning Software in Patients Receiving Reverse Shoulder Arthroplasty

NCT04474665 | Unknown FDA Device

• 1 other identifier: Blueprint-2019
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Reverse Shoulder Replacement

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (9)

• American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES)

  12 weeks

• American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES)

  6 months

• Simple Shoulder Test (SST) Questionnaire

  Pre-operative

• Simple Shoulder Test (SST) Questionnaire

  2 weeks

• Simple Shoulder Test (SST) Questionnaire

  6 weeks

Study Arms (1)

Implant placement accuracy

OTHER

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

Interventions

Reverse shoulder arthroplasty utilizing Blueprint Software DEVICE

Reverse shoulder arthroplasty utilizing Blueprint Software

Implant placement accuracy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Spine Institute of Louisiana Foundation: lead
• Stryker Trauma and Extremities: collaborator

Study Sites (1)

Spine Institute of Louisiana

Shreveport, Louisiana, 71101, United States

Location

Study Officials

• David Googe, MD

  Orthopedics Specialists of Louisiana

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2020
• First Posted: July 17, 2020
• Study Start: March 16, 2020
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: July 17, 2020

Record last verified: 2020-07

Locations

US (1)