Ignite Creation Date:
2025-12-24 @ 3:59 PM
Ignite Modification Date:
2026-01-02 @ 8:40 AM
Study NCT ID:
NCT05626192
Status:
UNKNOWN
Last Update Posted:
2024-03-21
First Post:
2022-11-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anatomical Evaluation of the APL Tendons in Thumb CMC Joint and Osteoarthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-11-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2024-12-23', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-20', 'studyFirstSubmitDate': '2022-11-15', 'studyFirstSubmitQcDate': '2022-11-15', 'lastUpdatePostDateStruct': {'date': '2024-03-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of APL tendon insertions in trapezium in thumb CMC joint', 'timeFrame': '12 months', 'description': 'Description of the distribution of the APL tendons in thumb CMC joint. Measure in number from 1 to 10 insertions.'}, {'measure': 'Osteophytes formation and thumb CMC joint osteoarthritis (OA)', 'timeFrame': '12 months', 'description': 'Thumb carpometacarpal joint osteoarthitis and osteophytes. Classifying the thumb OA in the specimens according to the International Cartilage Repair Society (ICRS) cartilage lesion classification system. Measure of the loss of cartilage in the CMC joint surface in millimeters (mm) with a digital caliper.'}], 'secondaryOutcomes': [{'measure': 'Sensory nerve endings and mechanoreceptors in thumb CMC joint', 'timeFrame': '12 months', 'description': 'Analyze the types of sensory nerve endings and mechanoreceptors in thumb CMC joint using immunohistochemical techniques: hematoxylin eosin , S100, PGP-95, in order to gain more insight into functional CMC joint stability. Measure in number from 0 to 20 sensory nerve endings.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Thumb Osteoarthritis', 'Enthesis organ', 'Sensory nerve endings'], 'conditions': ['Thumb Osteoarthritis']}, 'referencesModule': {'references': [{'pmid': '28719976', 'type': 'RESULT', 'citation': "Adams JE, O'Brien V, Magnusson E, Rosenstein B, Nuckley DJ. Radiographic Analysis of Simulated First Dorsal Interosseous and Opponens Pollicis Loading Upon Thumb CMC Joint Subluxation: A Cadaver Study. Hand (N Y). 2018 Jan;13(1):40-44. doi: 10.1177/1558944717691132. Epub 2017 Feb 16."}, {'pmid': '35172438', 'type': 'RESULT', 'citation': 'Choi SY, Rhim J, Han WJ, Park H, Noh JW, Han J, Ha CW. Associations between biomarkers and histological assessment in individual animals in a destabilization of the medial meniscus (DMM) model of osteoarthritis (OA). Acta Orthop Belg. 2021 Dec;87(4):713-721. doi: 10.52628/87.4.16.'}, {'pmid': '33789520', 'type': 'RESULT', 'citation': 'Deivasigamani S, Azad A, Yang SS. The Variable Insertional Anatomy of the Abductor Pollicis Longus: Functional Relevance and Relationship to Adjacent Thumb Extensors. Hand (N Y). 2023 Jan;18(1):145-152. doi: 10.1177/1558944721999734. Epub 2021 Apr 1.'}, {'pmid': '22117918', 'type': 'RESULT', 'citation': 'Gupta S, Michelsen-Jost H. Anatomy and function of the thenar muscles. Hand Clin. 2012 Feb;28(1):1-7. doi: 10.1016/j.hcl.2011.09.006.'}, {'pmid': '5591904', 'type': 'RESULT', 'citation': 'Freeman MA, Wyke B. The innervation of the ankle joint. An anatomical and histological study in the cat. Acta Anat (Basel). 1967;68(3):321-33. doi: 10.1159/000143037. No abstract available.'}, {'pmid': '22464234', 'type': 'RESULT', 'citation': 'Hagert E, Lee J, Ladd AL. Innervation patterns of thumb trapeziometacarpal joint ligaments. J Hand Surg Am. 2012 Apr;37(4):706-714.e1. doi: 10.1016/j.jhsa.2011.12.038.'}, {'pmid': '17218173', 'type': 'RESULT', 'citation': 'Hagert E, Garcia-Elias M, Forsgren S, Ljung BO. Immunohistochemical analysis of wrist ligament innervation in relation to their structural composition. J Hand Surg Am. 2007 Jan;32(1):30-6. doi: 10.1016/j.jhsa.2006.10.005.'}, {'pmid': '15237195', 'type': 'RESULT', 'citation': 'Hagert E, Ljung BO, Forsgren S. General innervation pattern and sensory corpuscles in the scapholunate interosseous ligament. Cells Tissues Organs. 2004;177(1):47-54. doi: 10.1159/000078427.'}, {'pmid': '24876685', 'type': 'RESULT', 'citation': 'Kofman KE, Schuurman AH, Mulder MC, Verlinde SA, Gierman LM, van Diest PJ, Bleys RL. The pisotriquetral joint: osteoarthritis and enthesopathy. J Hand Microsurg. 2014 Jun;6(1):18-25. doi: 10.1007/s12593-014-0129-3. Epub 2014 Apr 18.'}, {'pmid': '22992815', 'type': 'RESULT', 'citation': 'Ladd AL, Lee J, Hagert E. Macroscopic and microscopic analysis of the thumb carpometacarpal ligaments: a cadaveric study of ligament anatomy and histology. J Bone Joint Surg Am. 2012 Aug 15;94(16):1468-77. doi: 10.2106/JBJS.K.00329.'}, {'pmid': '26209165', 'type': 'RESULT', 'citation': "McGee C, O'Brien V, Van Nortwick S, Adams J, Van Heest A. First dorsal interosseous muscle contraction results in radiographic reduction of healthy thumb carpometacarpal joint. J Hand Ther. 2015 Oct-Dec;28(4):375-80; quiz 381. doi: 10.1016/j.jht.2015.06.002. Epub 2015 Jun 27."}, {'pmid': '31325208', 'type': 'RESULT', 'citation': 'Menz HB, Marshall M, Thomas MJ, Rathod-Mistry T, Peat GM, Roddy E. Associations Between Calcaneal Enthesophytes and Osteoarthritis of the Hands and Feet. Arthritis Care Res (Hoboken). 2020 Oct;72(10):1343-1348. doi: 10.1002/acr.24030.'}, {'pmid': '12610810', 'type': 'RESULT', 'citation': 'Moriggl B, Kumai T, Milz S, Benjamin M. The structure and histopathology of the "enthesis organ" at the navicular insertion of the tendon of tibialis posterior. J Rheumatol. 2003 Mar;30(3):508-17.'}, {'pmid': '19834771', 'type': 'RESULT', 'citation': 'Opreanu RC, Wechter J, Tabbaa H, Kepros JP, Baulch M, Xie Y, Lackey W, Katranji A. Anatomic variations of the first extensor compartment and abductor pollicis longus tendon in trapeziometacarpal arthritis. Hand (N Y). 2010 Jun;5(2):184-9. doi: 10.1007/s11552-009-9234-3. Epub 2009 Oct 16.'}, {'pmid': '22964904', 'type': 'RESULT', 'citation': 'Rein S, Hagert E, Hanisch U, Lwowski S, Fieguth A, Zwipp H. Immunohistochemical analysis of sensory nerve endings in ankle ligaments: a cadaver study. Cells Tissues Organs. 2013;197(1):64-76. doi: 10.1159/000339877. Epub 2012 Sep 4.'}, {'pmid': '33550482', 'type': 'RESULT', 'citation': 'Rein S, Krenn V, Hagert E, Garcia-Elias M, Lluch A, Kremer T, Semisch M. Degeneration of the articular disc in the human triangular fibrocartilage complex. Arch Orthop Trauma Surg. 2021 Apr;141(4):699-708. doi: 10.1007/s00402-021-03795-2. Epub 2021 Feb 6.'}, {'pmid': '12271357', 'type': 'RESULT', 'citation': 'Wu Z, Nagata K, Iijima T. Involvement of sensory nerves and immune cells in osteophyte formation in the ankle joint of adjuvant arthritic rats. Histochem Cell Biol. 2002 Sep;118(3):213-20. doi: 10.1007/s00418-002-0443-x. Epub 2002 Jul 19.'}]}, 'descriptionModule': {'briefSummary': 'Certain ligaments in the human body are designed to be a static stabilizer and others to have a sensory function thus remains an unresolved issue.\n\nThe presence of mechanoreceptors (sensory corpuscles and free nerve endins) in the human knee and ankle ligaments has implies a sensory role of ligaments in providing afferent information, which in turn regulates intrinsic stiffness in the muscles surrounding the joint, contribuiting to dynamic joint stability.\n\nThe aim of this study is to use immunohistochemical methods to analyze the general innervation and possible existence of sensory corpuscles in the thumb carpometacarpal (CMC) joint. This study can help to know the contribution of the tendon insertions and ligaments in the dynamic thumb CMC joint stability.', 'detailedDescription': 'The accessory APL tendons insertions, number of accessory tendons and insertion in trapezium can be a mechanical factor that develop osteophytes and thumb CMC joint osteoarthritis.\n\nAntibodies against the general nerve marker protein gene product 9.5 (PGP 9.5) and the glial marker S-100 will be use to depict innervation and corpuscular structures. Innervation pattern and sensory corpuscules were investigated by other authors in the wrist. S-100 immunoreactivity is in the Schwann cells in the central regions of the corpuscle, and PGP 9.5 immunoreactivity marked the axonal structures in the corpuscles. The presence of nerve fascicles and particularly sensory corpuscles in the structures, for exemple capsule and APL insertion near the thumb carpometacarpal joint suggest that these structures in the CMC joint have a propioceptive role in the stability of the joint.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The present study will include 20 specimens. The first part of the study will be a dissection of the specimens. Description of the variability of tendons in the first extensor compartment. The investigators analyze the APL tendon insertion, osteophytes formation and osteoarthritis in thumb CMC joint . In the second part of the study, the researchers will take a small sample of the APL insertion with the osteophyte, capsule and ligaments in the thumb CMC joint. The investigators will fix the sample in a solution of 4% formaldehyde and they will stain the samples with hematoxylin eosin. Immunohistochemistry with PGP 9.5 and S-100.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Specimens: Adults from 50 to 90 years.\n\nExclusion Criteria:\n\n* Specimens: younger than 50 or older than 90 years.'}, 'identificationModule': {'nctId': 'NCT05626192', 'briefTitle': 'Anatomical Evaluation of the APL Tendons in Thumb CMC Joint and Osteoarthritis', 'organization': {'class': 'OTHER', 'fullName': "Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau"}, 'officialTitle': 'Anatomical Evaluation of the APL and FCR Tendons in Thumb CMC Joint in Relation to Osteophytes Formation of the Trapezium and Osteoarthritis.', 'orgStudyIdInfo': {'id': 'IIBSP-CMC-2022-69'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Anatomical dissection and Immunohistochemical techniques', 'type': 'OTHER', 'description': 'Anatomical dissection and description'}]}, 'contactsLocationsModule': {'locations': [{'zip': '08025', 'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Claudia Erika Delgado Espinoza, MD, Ph D', 'role': 'CONTACT', 'email': 'CDelgadoE@santpau.cat', 'phone': '935537634'}, {'name': 'Claudia Erika Delgado Espinoza, MD, Ph D', 'role': 'CONTACT', 'email': 'CDelgadoE@santpau.cat'}], 'facility': 'Claudia Erika Delgado Espinoza', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08025', 'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Claudia Lamas, MD PhD', 'role': 'CONTACT', 'email': 'clamasg@santpau.cat', 'phone': '+34935537031'}, {'name': 'Claudia Lamas, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital de la Santa Creu i Sant Pau', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'centralContacts': [{'name': 'Claudia Lamas, MD, Ph D', 'role': 'CONTACT', 'email': 'clamasg@santpau.cat', 'phone': '935537032'}], 'overallOfficials': [{'name': 'Claudia Lamas, MD, Ph D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Protocol for the collection of anatomical variants of the APL tendon insertions and the association with osteophytes formation and thumb CMC joint osteoarthritis.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}