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NCT Number: NCT07375134

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

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.

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Key information

Conditions

Carpal Tunnel Syndrome (CTS) Carpal Tunnel Syndrome Cumulative Trauma Disorders Heel Pain Syndrome Median Neuropathy Mononeuropathies Nerve Compression Syndromes Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Sprains and Strains Wounds and Injuries

Age range

18 month and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Privé Paul d'Egine

Champigny-sur-Marne, 94500, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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).

    Time frame: perioperatively

    Intraoperative measurement of flexor retinacular ligament thickness

Secondary outcomes

  1. 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.

    Time frame: Baseline to six months after the surgery

    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).

  2. 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

    Time frame: Baseline to six months after the surgery

    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).

  3. 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

    Time frame: Immediately after the intervention to six months postoperatory

    Postoperative complications (inflammatory scar or keloid, complex regional pain syndrome, infection or hematoma).

Sponsors and collaborators

Lead sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Other

Registry information

Official study title

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

Acronym: ESTEREL

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 29, 2026
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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