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

March 20, 2024 updated by: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • Barcelona, Spain, 08025
        • Recruiting
        • Hospital de la Santa Creu i Sant Pau
        • Contact:
        • Principal Investigator:
          • Claudia Lamas, MD PhD
      • Barcelona, Spain, 08025
        • Recruiting
        • Claudia Erika Delgado Espinoza
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-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.

Description

Inclusion Criteria:

  • Specimens: Adults from 50 to 90 years.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of APL tendon insertions in trapezium in thumb CMC joint
Time Frame: 12 months
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)
Time Frame: 12 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensory nerve endings and mechanoreceptors in thumb CMC joint
Time Frame: 12 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Investigators

  • Principal Investigator: Claudia Lamas, MD, Ph D, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 13, 2022

Primary Completion (Estimated)

August 16, 2024

Study Completion (Estimated)

December 23, 2024

Study Registration Dates

First Submitted

November 15, 2022

First Submitted That Met QC Criteria

November 15, 2022

First Posted (Actual)

November 23, 2022

Study Record Updates

Last Update Posted (Actual)

March 21, 2024

Last Update Submitted That Met QC Criteria

March 20, 2024

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIBSP-CMC-2022-69

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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