NCT05626192

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2022

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 13, 2022

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

November 15, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 23, 2022

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 16, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 23, 2024

Completed
Last Updated

March 21, 2024

Status Verified

September 1, 2023

Enrollment Period

1.8 years

First QC Date

November 15, 2022

Last Update Submit

March 20, 2024

Conditions

Keywords

Thumb OsteoarthritisEnthesis organSensory nerve endings

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (1)

  • Sensory nerve endings and mechanoreceptors in thumb CMC joint

    12 months

Interventions

Anatomical dissection and description

Eligibility Criteria

Age50 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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.

You may qualify if:

  • Specimens: Adults from 50 to 90 years.

You may not qualify if:

  • Specimens: younger than 50 or older than 90 years.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Claudia Erika Delgado Espinoza

Barcelona, 08025, Spain

RECRUITING

Hospital de la Santa Creu i Sant Pau

Barcelona, 08025, Spain

RECRUITING

Related 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: 10.1177/1558944717691132. Epub 2017 Feb 16.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

Study Officials

  • Claudia Lamas, MD, Ph D

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Claudia Lamas, MD, Ph D

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2022

First Posted

November 23, 2022

Study Start

November 13, 2022

Primary Completion

August 16, 2024

Study Completion

December 23, 2024

Last Updated

March 21, 2024

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Protocol for the collection of anatomical variants of the APL tendon insertions and the association with osteophytes formation and thumb CMC joint osteoarthritis.

Locations