Observational Study - Heel Syndrome and Relationship to Flexor Retinacular Ligament Thickness (ESTEREL)

Evaluation of the Relationship Between Flexor Retinacular Ligament Thickness and the Development of Heel Pain Syndrome After Carpal Tunnel Surgery.

Numerous studies have examined the relationship between carpal tunnel syndrome and the thickness of the flexor retinacular ligament. This varies along the course of the median nerve (the distal portion being the thickest) and increases with age. These studies have shown that the thickness of the ligament is greater in patients with carpal tunnel syndrome, without, however, demonstrating that it is related to the onset of this syndrome. According to Bartolomé-Villar, it may rather influence the onset of carpal pain.

The objective of this study is to determine whether a relationship exists between the thickness of the flexor retinacular ligament and the development of heel syndrome in the postoperative period for carpal tunnel syndrome.

Study Overview

• Status: Active, not recruiting
• Conditions: Carpal Tunnel Syndrome (CTS); Heel Pain Syndrome

Detailed Description

This is a prospective, longitudinal, single-center, open-label observational study conducted on a population of patients operated on for carpal tunnel syndrome.

This study does not alter patient care or the doctor-patient relationship. Evaluations take place during routinely scheduled consultations. The frequency of evaluations is consistent with standard postoperative follow-up.

• Study Type: Observational
• Enrollment (Actual): 144

Contacts and Locations

Study Locations

• France
  • Champigny-sur-Marne, France, 94500
    • Hôpital Privé Paul d'Egine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients operated on for carpal tunnel syndrome by the same operator using the Chow technique.

Description

Inclusion Criteria :

• Male or female patient over 18 years of age
• Patient who has been informed of the research and has not indicated their opposition to the use of their medical data
• Patient who is a candidate for first-time carpal tunnel surgery

Exclusion Criteria :

• Emergency surgery performed in a post-traumatic context
• Mental impairment or any other reason that may hinder understanding or strict application of the protocol
• Patient not affiliated with the French social security system
• Patient under legal protection, guardianship, or curatorship
• Patient already included in another therapeutic study protocol

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Patients with heel-of-hand syndrome 6 months after surgery for carpal tunnel syndrome; Patients with heel of the hand syndrome, 6 months after surgery for carpal tunnel syndrome (measurement of retinacular ligament thickness intraoperatively)
Patients without heel of the hand syndrome 6 months after surgery for carpal tunnel syndrome; Patients without heel of the hand syndrome, 6 months after surgery for carpal tunnel syndrome (measurement of retinacular ligament thickness intraoperatively)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare the intraoperative measurement of flexor retinacular ligament thickness between the two groups of patients operated on for carpal tunnel syndrome by the same surgeon using the Chow technique (with and without hand heel syndrome).	Intraoperative measurement of flexor retinacular ligament thickness	perioperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess the existence of other factors that may be related to the occurrence of hand heel syndrome (Spontaneous pain) according to the initial characteristics and follow-up data of patients with and without hand heel syndrome.	Spontaneous pain in the heel of the hand assessed by the patient on a simple numeric rating scale (SNS) from 0 to 10 (0 = no pain, 10 = maximum pain).	Baseline to six months after the surgery
Assess the existence of other factors that may be linked to the occurrence of heel hand syndrome (Pain on palpation of the heel of the hand) based on initial characteristics and follow-up data, patients with and without hand heel syndrome	Pain on palpation of the heel of the hand assessed by the patient on a simple numeric rating scale (SNS) from 0 to 10 (0 = no pain, 10 = maximum pain).	Baseline to six months after the surgery
Assess the existence of other factors that may be linked to the occurrence of heel hand syndrome (Postoperative complications) based on follow-up data, patients with and without hand heel syndrome	Postoperative complications (inflammatory scar or keloid, complex regional pain syndrome, infection or hematoma).	Immediately after the intervention to six months postoperatory

Collaborators and Investigators

• Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
• Investigators: Principal Investigator: Antonio DINH, Dr, Hôpital Privé Paul d'Egine

Study record dates

Study Major Dates

• Study Start (Actual): October 22, 2024
• Primary Completion (Estimated): January 31, 2026
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: November 25, 2025
• First Submitted That Met QC Criteria: January 21, 2026
• First Posted (Actual): January 29, 2026

Study Record Updates

• Last Update Posted (Actual): January 29, 2026
• Last Update Submitted That Met QC Criteria: January 21, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: heel pain syndrome; patients operated on for carpal tunnel syndrome; thickness of the flexor retinacular ligament
• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Neuromuscular Diseases; Peripheral Nervous System Diseases; Median Neuropathy; Mononeuropathies; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Carpal Tunnel Syndrome
• Other Study ID Numbers: COS-RGDS-2023-12-034-P-DINH-A

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No