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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05626192
Other study ID # IIBSP-CMC-2022-69
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 13, 2022
Est. completion date December 23, 2024

Study information

Verified date September 2023
Source Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Contact Claudia Lamas, MD, Ph D
Phone 935537032
Email clamasg@santpau.cat
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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. The 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. The 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.


Description:

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. Antibodies 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date December 23, 2024
Est. primary completion date August 16, 2024
Accepts healthy volunteers No
Gender All
Age group 50 Years to 90 Years
Eligibility Inclusion Criteria: - Specimens: Adults from 50 to 90 years. Exclusion Criteria: - Specimens: younger than 50 or older than 90 years.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Anatomical dissection and Immunohistochemical techniques
Anatomical dissection and description

Locations

Country Name City State
Spain Claudia Erika Delgado Espinoza Barcelona
Spain Hospital de la Santa Creu i Sant Pau Barcelona

Sponsors (1)

Lead Sponsor Collaborator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Country where clinical trial is conducted

Spain, 

References & Publications (17)

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: 10.1177/155894 — View 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):713-7 — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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.2015.06.0 — View 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. — View 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. — View 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/s11 — View 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. — View 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. — View 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. — View Citation

* Note: There are 17 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Number of APL tendon insertions in trapezium in thumb CMC joint Description of the distribution of the APL tendons in thumb CMC joint. Measure in number from 1 to 10 insertions. 12 months
Primary Osteophytes formation and thumb CMC joint osteoarthritis (OA) 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. 12 months
Secondary Sensory nerve endings and mechanoreceptors in thumb CMC joint 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. 12 months
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