Clinical trial NCT06611059: Design of Patient Specific Guides (PSG) for Reverse Shoulder Arthroplasty
Official title: Design of Patient Specific Guides (PSG) for Reverse Shoulder Arthroplasty
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Proximal Humeral Fracture
Keywords: reverse shoulder arthroplasty
patient specific guide
3D
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
First posted: 2024-09-24
Enrollment: 11
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Inclusion Criteria:

* Patient with proximal humerus fracture candidate for reversed shoulder arthroplasty
* Patient with degenerative arthropathy candidate for reversed shoulder arthroplasty

Brief 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.

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 (\&amp;amp;amp;lt;1 mm error, compared to \&amp;amp;amp;gt; 4 mm under visual control) and orientation (\&amp;amp;amp;lt; 3◦ error compared to \&amp;amp;amp;gt; 7◦). In glenoids with more significant deformities, planning also showed superiority.

Eligibility criteria: Inclusion Criteria:

* Patient with proximal humerus fracture candidate for reversed shoulder arthroplasty
* Patient with degenerative arthropathy candidate for reversed shoulder arthroplasty

Exclusion Criteria:

* 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

Primary outcomes:
measure: Difference in glenoid center
timeFrame: months
measure: Glenoid version deviation (α)
timeFrame: months
measure: Glenoid inclination deviation (β)
timeFrame: months
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
Study officials:
affiliation: Orthopedic and Trauma Dept. / Trauma Unit
name: A. Millan
role: PRINCIPAL_INVESTIGATOR
affiliation: Orthopedic and Trauma Dept. / Trauma Unit
name: A. Toro
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Gonzalez 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.
citation: Jacquot 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.
citation: Berhouet 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.
citation: Gauci 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.
citation: Iannotti 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.
citation: Levy 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.
citation: Cabarcas 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.
citation: Dallalana 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.
citation: Cabarcas 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.
citation: Villatte 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.