Tornier Blueprint Planning Software in Patients Receiving Reverse Shoulder Arthroplasty

July 13, 2020 updated by: Spine Institute of Louisiana Foundation

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Range of motion
Time Frame: 6 months
Range of motion of the operative shoulder
6 months
Accuracy of sizing
Time Frame: Perioperative
Blueprint planned implant size compared to actual implant size
Perioperative
Time to plan/perform case
Time Frame: Pre-operative
Time required for surgeon to plan and perform the case using the Bluerpint software
Pre-operative
Time to plan/perform case
Time Frame: Perioperative
Time required for surgeon to plan and perform the case using the Bluerpint software
Perioperative

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES)
Time Frame: 12 weeks
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)
Time Frame: 6 months
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
Time Frame: Pre-operative
12 yes/no questions to understand your daily functionality concerning your shoulder.
Pre-operative
Simple Shoulder Test (SST) Questionnaire
Time Frame: 2 weeks
12 yes/no questions to understand your daily functionality concerning your shoulder.
2 weeks
Simple Shoulder Test (SST) Questionnaire
Time Frame: 6 weeks
12 yes/no questions to understand your daily functionality concerning your shoulder.
6 weeks
Simple Shoulder Test (SST) Questionnaire
Time Frame: 12 weeks
12 yes/no questions to understand your daily functionality concerning your shoulder.
12 weeks
Simple Shoulder Test (SST) Questionnaire
Time Frame: 6 months
12 yes/no questions to understand your daily functionality concerning your shoulder.
6 months
Patient Satisfaction
Time Frame: 12 weeks
Patient rated satisfaction with surgical treatment rated; very satisfied, somewhat satisfied, somewhat dissatisfied, or very dissatisfied
12 weeks
Patient Satisfaction
Time Frame: 6 months
Patient rated satisfaction with surgical treatment rated; very satisfied, somewhat satisfied, somewhat dissatisfied, or very dissatisfied
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Spine Institute of Louisiana Foundation

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Stryker Trauma GmbH

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: David Googe, MD, Orthopedics Specialists of Louisiana

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 16, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 8, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 17, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 17, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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