Proximal Humeral FracturePSGNCT06611059
Design of Patient Specific Guides (PSG) for Reverse Shoulder Arthroplasty
An observational study of Proximal Humeral Fracture, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial summary
This is a two steps observational study In the first part we will compare the accuracy of the commercial guide against a in-hospital designed patient specific guide. As a secondary goal, the problems detected during the design phase will be described. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Proximal Humeral Fracture
- What is being tested?
- PSG
- Type of treatment
- Medical device
- How many people
- 11 participants
- Where
- 1 siteSpain
- Study dates
- 1 Apr 2023to 23 Jan 2024
- How long will I take part?
- 6 Months
- Phase
- Observational
- 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 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Inclusion Criteria: * Patient with proximal humerus fracture candidate for reversed shoulder arthroplasty * Patient with degenerative arthropathy candidate for reversed shoulder arthroplasty
Who may be able to join
- Patient with proximal humerus fracture candidate for reversed shoulder arthroplasty
- Patient with degenerative arthropathy candidate for reversed shoulder arthroplasty
Who cannot join
- Previous surgeries on the proximal humerus or glenoid
- No desire to participate in the study
- Lack of ability to accept the study (tutored patients)
- Open fractures
Trial locations and contacts
1 site in 1 country.
About this study
This is a two steps observational study
In the first part we will compare the accuracy of the commercial guide against a in-hospital designed patient specific guide. As a secondary goal, the problems detected during the design phase will be described.
Once the accuracy of the guide is acceptable, we will implant the glenosphere of future patients using the PSG guide following the same engineering design process.
Read the detailed description
Reverse shoulder arthroplasty is a treatment for both non-synthesizable fractures and arthropathy degenerative. This implant is based on two main components: glenosphere and stem. The stem in turn is integrated in its upper part by a polyethylene that reduces the friction torque between the glenosphere and the stem.
Correct positioning of the glenosphere is critical for functionality and survival of the implant. Malpositioning of glenosphere can be related to:
In recent years, given the
- The scapula is a flat bone, without any reference axis;
- Surgical approaches expose only the glenoid cavity, with few bone landmarks;
- The humerus and deltoid make access to the glenoid difficult;
- The morphology of the scapula is very variable.
Preoperative planning even without PSG improves the positioning accuracy of the guide in the glenoid. In glenoids with only a slight deformity, PSGs improve the accuracy of the guide entry point (\<1 mm error, compared to \> 4 mm under visual control) and orientation (\< 3◦ error compared to \> 7◦). In glenoids with more significant deformities, planning also showed superiority.
- Conditions
- Proximal Humeral Fracture
- Being tested
- PSG
- Keywords
- reverse shoulder arthroplasty, patient specific guide, 3D
- Medical subject headings
- Shoulder Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PSGDevice
Also called Patient Specific Guides
Two replicas of each scapula are made. The scapulae are drilled with a commercial guide and with an in-house guide separately
| Study group | Role | What they receive |
|---|---|---|
| in-hospital designed patient specific guide | Not described Receives: Device: PSG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in glenoid center
Difference in glenoid center (mm): distance between the points of entry on the surface of the scapula, the planned center versus the finally drawn
Measured: months
Glenoid version deviation (α)
Glenoid version deviation (α): defined as the angle between the real trajectory of the drilling and the scapular anatomical plane, projected about the axis of neutral inclination (defined as that which goes from the center of the glenoid to the trigonum spinae).
Measured: months
Glenoid inclination deviation (β)
Glenoid inclination deviation (β): defined as the angle between the actual milling path and the plane of the neutral tilt axis, projected on the SP axis
Measured: months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2024
- Study start1 Apr 2023
- Primary completion23 Jan 2024
- Study completion23 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Proximal Humeral FractureStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 11 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- A. Millan, Principal investigator, Orthopedic and Trauma Dept. / Trauma UnitA. Toro, Study director, Orthopedic and Trauma Dept. / Trauma Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06611059
- Sponsor's protocol ID
- IIBSP-PSG-2023-107
- Other IDs
- IIBSP-PSG-2023-107
- Acronym
- PSG
- Status last verified
- Nov 2024
- First submitted
- 19 Dec 2023
- Last updated
- 6 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gauci MO. Patient-specific guides in orthopedic surgery. Orthop Traumatol Surg Res. 2022 Feb;108(1S):103154. doi: 10.1016/j.otsr.2021.103154. Epub 2021 Nov 24.
PubMed 34838754Gonzalez JF, Alami GB, Baque F, Walch G, Boileau P. Complications of unconstrained shoulder prostheses. J Shoulder Elbow Surg. 2011 Jun;20(4):666-82. doi: 10.1016/j.jse.2010.11.017. Epub 2011 Mar 21. No abstract available.
PubMed 21419661Jacquot A, Gauci MO, Chaoui J, Baba M, Deransart P, Boileau P, Mole D, Walch G. Proper benefit of a three dimensional pre-operative planning software for glenoid component positioning in total shoulder arthroplasty. Int Orthop. 2018 Dec;42(12):2897-2906. doi: 10.1007/s00264-018-4037-1. Epub 2018 Jul 2.
PubMed 29968136Berhouet J, Gulotta LV, Dines DM, Craig E, Warren RF, Choi D, Chen X, Kontaxis A. Preoperative planning for accurate glenoid component positioning in reverse shoulder arthroplasty. Orthop Traumatol Surg Res. 2017 May;103(3):407-413. doi: 10.1016/j.otsr.2016.12.019. Epub 2017 Feb 24.
PubMed 28238965Gauci MO, Boileau P, Baba M, Chaoui J, Walch G. Patient-specific glenoid guides provide accuracy and reproducibility in total shoulder arthroplasty. Bone Joint J. 2016 Aug;98-B(8):1080-5. doi: 10.1302/0301-620X.98B8.37257.
PubMed 27482021Iannotti JP, Walker K, Rodriguez E, Patterson TE, Jun BJ, Ricchetti ET. Accuracy of 3-Dimensional Planning, Implant Templating, and Patient-Specific Instrumentation in Anatomic Total Shoulder Arthroplasty. J Bone Joint Surg Am. 2019 Mar 6;101(5):446-457. doi: 10.2106/JBJS.17.01614.
PubMed 30845039Levy JC, Everding NG, Frankle MA, Keppler LJ. Accuracy of patient-specific guided glenoid baseplate positioning for reverse shoulder arthroplasty. J Shoulder Elbow Surg. 2014 Oct;23(10):1563-7. doi: 10.1016/j.jse.2014.01.051. Epub 2014 Apr 13.
PubMed 24739791Cabarcas BC, Cvetanovich GL, Espinoza-Orias AA, Inoue N, Gowd AK, Bernardoni E, Verma NN. Novel 3-dimensionally printed patient-specific guide improves accuracy compared with standard total shoulder arthroplasty guide: a cadaveric study. JSES Open Access. 2019 Jun 15;3(2):83-92. doi: 10.1016/j.jses.2019.04.001. eCollection 2019 Jul.
PubMed 31334434Dallalana RJ, McMahon RA, East B, Geraghty L. Accuracy of patient-specific instrumentation in anatomic and reverse total shoulder arthroplasty. Int J Shoulder Surg. 2016 Apr-Jun;10(2):59-66. doi: 10.4103/0973-6042.180717.
PubMed 27186057Cabarcas BC, Cvetanovich GL, Gowd AK, Liu JN, Manderle BJ, Verma NN. Accuracy of patient-specific instrumentation in shoulder arthroplasty: a systematic review and meta-analysis. JSES Open Access. 2019 Sep 18;3(3):117-129. doi: 10.1016/j.jses.2019.07.002. eCollection 2019 Oct.
PubMed 31709351Villatte G, Muller AS, Pereira B, Mulliez A, Reilly P, Emery R. Use of Patient-Specific Instrumentation (PSI) for glenoid component positioning in shoulder arthroplasty. A systematic review and meta-analysis. PLoS One. 2018 Aug 22;13(8):e0201759. doi: 10.1371/journal.pone.0201759. eCollection 2018.
PubMed 30133482
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Design of Patient Specific Guides (PSG) for Reverse Shoulder Arthroplasty
- ClinicalTrials.gov ID
- NCT06611059
- Acronym / sponsor ID
- PSG / IIBSP-PSG-2023-107
- Conditions
- Proximal Humeral Fracture
- Keywords
- reverse shoulder arthroplasty, patient specific guide, 3D
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 23 Jan 2024 (actual)
- Study completion
- 23 Jan 2024 (actual)
- First posted
- 24 Sep 2024 (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.
This is a two steps observational study
In the first part we will compare the accuracy of the commercial guide against a in-hospital designed patient specific guide. As a secondary goal, the problems detected during the design phase will be described.
Once the accuracy of the guide is acceptable, we will implant the glenosphere of future patients using the PSG guide following the same engineering design process.
Detailed description
Reverse shoulder arthroplasty is a treatment for both non-synthesizable fractures and arthropathy degenerative. This implant is based on two main components: glenosphere and stem. The stem in turn is integrated in its upper part by a polyethylene that reduces the friction torque between the glenosphere and the stem.
Correct positioning of the glenosphere is critical for functionality and survival of the implant. Malpositioning of glenosphere can be related to:
In recent years, given the
- The scapula is a flat bone, without any reference axis;
- Surgical approaches expose only the glenoid cavity, with few bone landmarks;
- The humerus and deltoid make access to the glenoid difficult;
- The morphology of the scapula is very variable.
Preoperative planning even without PSG improves the positioning accuracy of the guide in the glenoid. In glenoids with only a slight deformity, PSGs improve the accuracy of the guide entry point (\<1 mm error, compared to \> 4 mm under visual control) and orientation (\< 3◦ error compared to \> 7◦). In glenoids with more significant deformities, planning also showed superiority.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| in-hospital designed patient specific guide | – | Device: PSG |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Inclusion Criteria: * Patient with proximal humerus fracture candidate for reversed shoulder arthroplasty * Patient with degenerative arthropathy candidate for reversed shoulder arthroplasty
Key inclusion criteria (2 listed)
- Patient with proximal humerus fracture candidate for reversed shoulder arthroplasty
- Patient with degenerative arthropathy candidate for reversed shoulder arthroplasty
Key exclusion criteria (4 listed)
- Previous surgeries on the proximal humerus or glenoid
- No desire to participate in the study
- Lack of ability to accept the study (tutored patients)
- Open fractures
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 |
|---|---|---|
| PSGAlso: Patient Specific GuidesTwo replicas of each scapula are made. The scapulae are drilled with a commercial guide and with an in-house guide separately | Device | in-hospital designed patient specific guide |
Primary outcome
Difference in glenoid center
Time frame: months
Difference in glenoid center (mm): distance between the points of entry on the surface of the scapula, the planned center versus the finally drawn
Glenoid version deviation (α)
Time frame: months
Glenoid version deviation (α): defined as the angle between the real trajectory of the drilling and the scapular anatomical plane, projected about the axis of neutral inclination (defined as that which goes from the center of the glenoid to the trigonum spinae).
Glenoid inclination deviation (β)
Time frame: months
Glenoid inclination deviation (β): defined as the angle between the actual milling path and the plane of the neutral tilt axis, projected on the SP axis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2024.
- Results publication: PubMed 34838754Gauci MO. Patient-specific guides in orthopedic surgery. Orthop Traumatol Surg Res. 2022 Feb;108(1S):103154. doi: 10.1016/j.otsr.2021.103154. Epub 2021 Nov 24.
- Results publication: PubMed 21419661Gonzalez JF, Alami GB, Baque F, Walch G, Boileau P. Complications of unconstrained shoulder prostheses. J Shoulder Elbow Surg. 2011 Jun;20(4):666-82. doi: 10.1016/j.jse.2010.11.017. Epub 2011 Mar 21. No abstract available.
- Results publication: PubMed 29968136Jacquot A, Gauci MO, Chaoui J, Baba M, Deransart P, Boileau P, Mole D, Walch G. Proper benefit of a three dimensional pre-operative planning software for glenoid component positioning in total shoulder arthroplasty. Int Orthop. 2018 Dec;42(12):2897-2906. doi: 10.1007/s00264-018-4037-1. Epub 2018 Jul 2.
- Results publication: PubMed 28238965Berhouet J, Gulotta LV, Dines DM, Craig E, Warren RF, Choi D, Chen X, Kontaxis A. Preoperative planning for accurate glenoid component positioning in reverse shoulder arthroplasty. Orthop Traumatol Surg Res. 2017 May;103(3):407-413. doi: 10.1016/j.otsr.2016.12.019. Epub 2017 Feb 24.
- Results publication: PubMed 27482021Gauci MO, Boileau P, Baba M, Chaoui J, Walch G. Patient-specific glenoid guides provide accuracy and reproducibility in total shoulder arthroplasty. Bone Joint J. 2016 Aug;98-B(8):1080-5. doi: 10.1302/0301-620X.98B8.37257.
- Results publication: PubMed 30845039Iannotti JP, Walker K, Rodriguez E, Patterson TE, Jun BJ, Ricchetti ET. Accuracy of 3-Dimensional Planning, Implant Templating, and Patient-Specific Instrumentation in Anatomic Total Shoulder Arthroplasty. J Bone Joint Surg Am. 2019 Mar 6;101(5):446-457. doi: 10.2106/JBJS.17.01614.
- Results publication: PubMed 24739791Levy JC, Everding NG, Frankle MA, Keppler LJ. Accuracy of patient-specific guided glenoid baseplate positioning for reverse shoulder arthroplasty. J Shoulder Elbow Surg. 2014 Oct;23(10):1563-7. doi: 10.1016/j.jse.2014.01.051. Epub 2014 Apr 13.
- Results publication: PubMed 31334434Cabarcas BC, Cvetanovich GL, Espinoza-Orias AA, Inoue N, Gowd AK, Bernardoni E, Verma NN. Novel 3-dimensionally printed patient-specific guide improves accuracy compared with standard total shoulder arthroplasty guide: a cadaveric study. JSES Open Access. 2019 Jun 15;3(2):83-92. doi: 10.1016/j.jses.2019.04.001. eCollection 2019 Jul.
- Results publication: PubMed 27186057Dallalana RJ, McMahon RA, East B, Geraghty L. Accuracy of patient-specific instrumentation in anatomic and reverse total shoulder arthroplasty. Int J Shoulder Surg. 2016 Apr-Jun;10(2):59-66. doi: 10.4103/0973-6042.180717.
- Results publication: PubMed 31709351Cabarcas BC, Cvetanovich GL, Gowd AK, Liu JN, Manderle BJ, Verma NN. Accuracy of patient-specific instrumentation in shoulder arthroplasty: a systematic review and meta-analysis. JSES Open Access. 2019 Sep 18;3(3):117-129. doi: 10.1016/j.jses.2019.07.002. eCollection 2019 Oct.
- Results publication: PubMed 30133482Villatte G, Muller AS, Pereira B, Mulliez A, Reilly P, Emery R. Use of Patient-Specific Instrumentation (PSI) for glenoid component positioning in shoulder arthroplasty. A systematic review and meta-analysis. PLoS One. 2018 Aug 22;13(8):e0201759. doi: 10.1371/journal.pone.0201759. eCollection 2018.
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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.
A. Millan principal investigator
Orthopedic and Trauma Dept. / Trauma Unit
A. Toro study director
Orthopedic and Trauma Dept. / Trauma Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Proximal Humeral Fracture, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
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 2 inclusion and 4 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: finished, as of the sponsor's last update on 6 Nov 2024. 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 Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Difference in glenoid center (time frame: months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06611059, which also lists 11 linked publications.
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 6 Nov 2024.