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

NCT07375134 | Active Not Recruiting

• 1 other identifier: COS-RGDS-2023-12-034-P-DINH-A
• Study Type: observational
• Target: 144
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

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).

  Intraoperative measurement of flexor retinacular ligament thickness

  perioperatively

Secondary Outcomes (3)

• 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 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

  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

  Immediately after the intervention to six months postoperatory

Study Arms (2)

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)

Eligibility Criteria

• Age: 18 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GCS Ramsay Santé pour l'Enseignement et la Recherche: lead

Study Sites (1)

Hôpital Privé Paul d'Egine

Champigny-sur-Marne, 94500, France

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Study Officials

• Antonio DINH, Dr

  Hôpital Privé Paul d'Egine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: January 29, 2026
• Study Start: October 22, 2024
• Primary Completion: January 31, 2026
• Study Completion: February 1, 2026
• Last Updated: January 29, 2026

Record last verified: 2026-01

Locations

FR (1)