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Thumb OsteoarthritisNCT05626192

Anatomical Evaluation of the APL Tendons in Thumb CMC Joint and Osteoarthritis

An observational study of Thumb Osteoarthritis, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 2 sites in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 50 to 90 years
Conditions the study is for
Thumb Osteoarthritis
What is being tested?
Anatomical dissection and Immunohistochemical techniques
How many people
20 participants
Where
2 sitesSpain
Study dates
13 Nov 2022to 23 Dec 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • Specimens: Adults from 50 to 90 years.

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

Claudia Lamas, MD, Ph D contact

935537032

clamasg@santpau.cat

Spain2 sites, 2 recruiting

  • Claudia Erika Delgado Espinoza

    Barcelona, 08025

    Claudia Erika Delgado Espinoza, MD, Ph D, 935537634, CDelgadoE@santpau.cat

    Claudia Erika Delgado Espinoza, MD, Ph D, CDelgadoE@santpau.cat

    Recruiting

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08025

    Claudia Lamas, MD PhD, +34935537031, clamasg@santpau.cat

    Claudia Lamas, MD PhD

    Recruiting

Other trials in Spain

About this study

Official title: Anatomical Evaluation of the APL and FCR Tendons in Thumb CMC Joint in Relation to Osteophytes Formation of the Trapezium and Osteoarthritis.

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.

Read the detailed 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.

Being tested
Anatomical dissection and Immunohistochemical techniques
Keywords
Thumb Osteoarthritis, Enthesis organ, Sensory nerve endings

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Anatomical dissection and Immunohistochemical techniquesOther

    Anatomical dissection and description

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 12 months

  2. 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.

    Measured: 12 months

Secondary outcomes (1)

  1. 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.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Nov 2022
  2. Study start13 Nov 2022
  3. Primary completion16 Aug 2024 (estimated)
  4. Study completion23 Dec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05626192
Sponsor's protocol ID
IIBSP-CMC-2022-69
Status last verified
Sep 2023
First submitted
15 Nov 2022
Last updated
21 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Protocol for the collection of anatomical variants of the APL tendon insertions and the association with osteophytes formation and thumb CMC joint osteoarthritis.

Publications

  • 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.

    PubMed 28719976

  • 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.

    PubMed 35172438

  • 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.

    PubMed 33789520

  • 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.

    PubMed 22117918

  • 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.

    PubMed 5591904

  • 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.

    PubMed 22464234

  • 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.

    PubMed 17218173

  • 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.

    PubMed 15237195

  • 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.

    PubMed 24876685

  • 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.

    PubMed 22992815

  • 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.

    PubMed 26209165

  • 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.

    PubMed 31325208

  • 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.

    PubMed 12610810

  • 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.

    PubMed 19834771

  • 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.

    PubMed 22964904

Questions about this trial

What is this clinical trial studying?

An observational study of Thumb Osteoarthritis, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 2 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Claudia Lamas, MD, Ph D (935537032, clamasg@santpau.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of APL tendon insertions in trapezium in thumb CMC joint (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05626192, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2024; AzTrials last refreshed its copy on 7 Nov 2026.

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