Reverse Shoulder ReplacementNCT04474665
Tornier Blueprint Planning Software in Patients Receiving Reverse Shoulder Arthroplasty
A study testing Reverse shoulder arthroplasty utilizing Blueprint Software in people with Reverse Shoulder Replacement, run by Spine Institute of Louisiana Foundation at 1 site in United States.
Trial summary
Compare sizing determined in pre-operative planning of reverse shoulder arthroplasty to operative implant size selected. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Reverse Shoulder Replacement
- What is being tested?
- Reverse shoulder arthroplasty utilizing Blueprint Software
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Mar 2020to 1 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Spine Institute of Louisiana
Shreveport, Louisiana, 71101
About this study
Official title: 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.
Read the 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
- Being tested
- Reverse shoulder arthroplasty utilizing Blueprint Software
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reverse shoulder arthroplasty utilizing Blueprint SoftwareDevice
Reverse shoulder arthroplasty utilizing Blueprint Software
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Reverse shoulder arthroplasty utilizing Blueprint Software |
What is being measured
The primary outcome is the main question the study is designed to answer.
Range of motion
Range of motion of the operative shoulder
Measured: 6 months
Accuracy of sizing
Blueprint planned implant size compared to actual implant size
Measured: Perioperative
Time to plan/perform case
Time required for surgeon to plan and perform the case using the Bluerpint software
Measured: Pre-operative
Time to plan/perform case
Time required for surgeon to plan and perform the case using the Bluerpint software
Measured: Perioperative
Secondary outcomes (9)
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.
Measured: 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.
Measured: 6 months
Simple Shoulder Test (SST) Questionnaire
12 yes/no questions to understand your daily functionality concerning your shoulder.
Measured: Pre-operative
Simple Shoulder Test (SST) Questionnaire
12 yes/no questions to understand your daily functionality concerning your shoulder.
Measured: 2 weeks
Simple Shoulder Test (SST) Questionnaire
12 yes/no questions to understand your daily functionality concerning your shoulder.
Measured: 6 weeks
Simple Shoulder Test (SST) Questionnaire
12 yes/no questions to understand your daily functionality concerning your shoulder.
Measured: 12 weeks
Simple Shoulder Test (SST) Questionnaire
12 yes/no questions to understand your daily functionality concerning your shoulder.
Measured: 6 months
Patient Satisfaction
Patient rated satisfaction with surgical treatment rated; very satisfied, somewhat satisfied, somewhat dissatisfied, or very dissatisfied
Measured: 12 weeks
Patient Satisfaction
Patient rated satisfaction with surgical treatment rated; very satisfied, somewhat satisfied, somewhat dissatisfied, or very dissatisfied
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2020
- Study start16 Mar 2020
- Primary completion1 Jun 2021 (estimated)
- Study completion1 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reverse Shoulder ReplacementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Spine Institute of Louisiana Foundation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Stryker Trauma and Extremities
- Responsible party
- Sponsor
- Investigators
- David Googe, MD, Principal investigator, Orthopedics Specialists of Louisiana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04474665
- Sponsor's protocol ID
- Blueprint-2019
- Status last verified
- Jul 2020
- First submitted
- 8 Jul 2020
- Last updated
- 17 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Prospective Study of Tornier Blueprint Planning Software in Patients Receiving Reverse Shoulder Arthroplasty
- ClinicalTrials.gov ID
- NCT04474665
- Acronym / sponsor ID
- Blueprint-2019
- Conditions
- Reverse Shoulder Replacement
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Spine Institute of Louisiana FoundationIndustry (pharma, biotech, devices)
- Collaborators
- Stryker Trauma and Extremities
- Study start
- 16 Mar 2020 (actual)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 1 Jun 2021 (estimated)
- First posted
- 17 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Implant placement accuracy | Other | Device: Reverse shoulder arthroplasty utilizing Blueprint SoftwareBlueprint planning software will be used to plan reverse shoulder replacement surgery. Accuracy of the placement compared to the plan will be assessed post-surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reverse shoulder arthroplasty utilizing Blueprint SoftwareReverse shoulder arthroplasty utilizing Blueprint Software | Device | Implant placement accuracy |
Primary outcome
Range of motion
Time frame: 6 months
Range of motion of the operative shoulder
Accuracy of sizing
Time frame: Perioperative
Blueprint planned implant size compared to actual implant size
Time to plan/perform case
Time frame: Pre-operative
Time required for surgeon to plan and perform the case using the Bluerpint software
Time to plan/perform case
Time frame: Perioperative
Time required for surgeon to plan and perform the case using the Bluerpint software
9 secondary outcomes
American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES)
Time frame: 12 weeks
American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES)
Time frame: 6 months
Simple Shoulder Test (SST) Questionnaire
Time frame: Pre-operative
Simple Shoulder Test (SST) Questionnaire
Time frame: 2 weeks
Simple Shoulder Test (SST) Questionnaire
Time frame: 6 weeks
Simple Shoulder Test (SST) Questionnaire
Time frame: 12 weeks
Simple Shoulder Test (SST) Questionnaire
Time frame: 6 months
Patient Satisfaction
Time frame: 12 weeks
Patient Satisfaction
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Googe, MD principal investigator
Orthopedics Specialists of Louisiana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reverse shoulder arthroplasty utilizing Blueprint Software in people with Reverse Shoulder Replacement, run by Spine Institute of Louisiana Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Range of motion (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2020.