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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07375134
Acronym
ESTEREL
Enrollment
144
Registered
2026-01-29
Start date
2024-10-22
Completion date
2026-06-01
Last updated
2026-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carpal Tunnel Syndrome (CTS), Heel Pain Syndrome

Keywords

heel pain syndrome, patients operated on for carpal tunnel syndrome, thickness of the flexor retinacular ligament

Brief summary

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.

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.

Interventions

None listed

Sponsors

GCS Ramsay Santé pour l'Enseignement et la Recherche
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Months to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
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).perioperativelyIntraoperative measurement of flexor retinacular ligament thickness

Secondary

MeasureTime frameDescription
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.Baseline to six months after the surgerySpontaneous 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).
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 syndromeBaseline to six months after the surgeryPain 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).
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 syndromeImmediately after the intervention to six months postoperatoryPostoperative complications (inflammatory scar or keloid, complex regional pain syndrome, infection or hematoma).

Countries

France

Contacts

PRINCIPAL_INVESTIGATORAntonio DINH, Dr

Hôpital Privé Paul d'Egine

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 6, 2026