Ignite Creation Date:
2025-12-24 @ 2:32 PM
Ignite Modification Date:
2026-01-06 @ 11:05 PM
Study NCT ID:
NCT06611059
Status:
COMPLETED
Last Update Posted:
2024-11-06
First Post:
2023-12-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Design of Patient Specific Guides (PSG) for Reverse Shoulder Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012784', 'term': 'Shoulder Fractures'}], 'ancestors': [{'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D000070599', 'term': 'Shoulder Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2024-01-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-04', 'studyFirstSubmitDate': '2023-12-19', 'studyFirstSubmitQcDate': '2024-09-23', 'lastUpdatePostDateStruct': {'date': '2024-11-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference in glenoid center', 'timeFrame': 'months', 'description': 'Difference in glenoid center (mm): distance between the points of entry on the surface of the scapula, the planned center versus the finally drawn'}, {'measure': 'Glenoid version deviation (α)', 'timeFrame': 'months', 'description': '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).'}, {'measure': 'Glenoid inclination deviation (β)', 'timeFrame': 'months', 'description': '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'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['reverse shoulder arthroplasty', 'patient specific guide', '3D'], 'conditions': ['Proximal Humeral Fracture']}, 'referencesModule': {'references': [{'pmid': '34838754', 'type': 'BACKGROUND', '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.'}, {'pmid': '21419661', 'type': 'BACKGROUND', '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.'}, {'pmid': '29968136', 'type': 'BACKGROUND', '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.'}, {'pmid': '28238965', 'type': 'BACKGROUND', '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.'}, {'pmid': '27482021', 'type': 'BACKGROUND', '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.'}, {'pmid': '30845039', 'type': 'BACKGROUND', '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.'}, {'pmid': '24739791', 'type': 'BACKGROUND', '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.'}, {'pmid': '31334434', 'type': 'BACKGROUND', '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.'}, {'pmid': '27186057', 'type': 'BACKGROUND', '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.'}, {'pmid': '31709351', 'type': 'BACKGROUND', '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.'}, {'pmid': '30133482', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': 'This is a two steps observational study\n\nIn 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.\n\nOnce 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.', 'detailedDescription': '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.\n\nCorrect positioning of the glenosphere is critical for functionality and survival of the implant. Malpositioning of glenosphere can be related to:\n\nIn recent years, given the\n\n* The scapula is a flat bone, without any reference axis;\n* Surgical approaches expose only the glenoid cavity, with few bone landmarks;\n* The humerus and deltoid make access to the glenoid difficult;\n* The morphology of the scapula is very variable.\n\nPreoperative 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Inclusion Criteria:\n\n* Patient with proximal humerus fracture candidate for reversed shoulder arthroplasty\n* Patient with degenerative arthropathy candidate for reversed shoulder arthroplasty', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with proximal humerus fracture candidate for reversed shoulder arthroplasty\n* Patient with degenerative arthropathy candidate for reversed shoulder arthroplasty\n\nExclusion Criteria:\n\n* Previous surgeries on the proximal humerus or glenoid\n* No desire to participate in the study\n* Lack of ability to accept the study (tutored patients)\n* Open fractures'}, 'identificationModule': {'nctId': 'NCT06611059', 'acronym': 'PSG', 'briefTitle': 'Design of Patient Specific Guides (PSG) for Reverse Shoulder Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': "Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau"}, 'officialTitle': 'Design of Patient Specific Guides (PSG) for Reverse Shoulder Arthroplasty', 'orgStudyIdInfo': {'id': 'IIBSP-PSG-2023-107'}, 'secondaryIdInfos': [{'id': 'IIBSP-PSG-2023-107', 'type': 'REGISTRY', 'domain': 'Clinical Research Ethics Committee'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'in-hospital designed patient specific guide', 'interventionNames': ['Device: PSG']}], 'interventions': [{'name': 'PSG', 'type': 'DEVICE', 'otherNames': ['Patient Specific Guides'], 'description': 'Two replicas of each scapula are made. The scapulae are drilled with a commercial guide and with an in-house guide separately', 'armGroupLabels': ['in-hospital designed patient specific guide']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08025', 'city': 'Barcelona', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital de la Santa Creu i Sant Pau', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'overallOfficials': [{'name': 'A. Millan', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Orthopedic and Trauma Dept. / Trauma Unit'}, {'name': 'A. Toro', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Orthopedic and Trauma Dept. / Trauma Unit'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}