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Not yet recruiting NCT07404514

Longitudinal Ulnar Deficit (ULNEER)

Observational Ulnar Longitudinal Deficiency Ulnar Hand Deformity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Ulnar Longitudinal Deficiency, Ulnar Hand Deformity. Basic parameters: 3 years — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Prospective and Retrospective Observational Study on Longitudinal Ulnar Deficit: Analysis of Existing Medical Data and Parental Questionnaires

Overview

The management of patients with longitudinal ulnar deficiency is a clinical challenge due to the rarity of this condition and the wide variety of its manifestations. In particular, there is no consensus in the literature on the indications for surgery. The aim of this research is to improve understanding and management of this malformation by analyzing existing data from patient medical follow-up. No new clinical evaluations or occupational therapy assessments will be performed specifically for this study. The analysis will be based on previous medical and paramedical data (consultation reports, imaging, occupational therapy assessments, etc.) in order to better describe the functional evolution of patients and identify the decision-making criteria that guide surgical management. Parents will also receive standardized questionnaires (PROMIS and ABILHAND-Kids-CP) to gather their perceptions of their child's quality of life and independence. The results will be used to propose recommendations for a more consistent and multidisciplinary assessment of longitudinal ulnar deficit in the future.

Primary outcome measures

  • Upper limb function and health-related quality of life (PROMIS Upper Extremity and ABILHAND-Kids) [Time frame: From baseline to study completion (up to 10 months)]
Secondary outcome measures (3)
  • Upper limb functional ability score [Time frame: From baseline to study completion (up to 10 months)]
  • Pediatric upper limb function [Time frame: From baseline to study completion (up to 10 months)]
  • Pediatric health-related quality of life [Time frame: From baseline to study completion (up to 10 months)]

Eligibility criteria

Inclusion criteria

  • Patients with unilateral or bilateral ulnar hand deformity, whether operated on or not
  • Follow-up at CEREFAM and/or Trousseau Hospital
  • Complete medical records containing previous assessments

Exclusion criteria

  • Non-French-speaking patient
  • No preoperative or postoperative assessment

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 1 center
  • Hôpitaux Paris Est Val-de-Marne - Centre de Référence des Malformations des Membres — Saint-Maurice

Identifiers

NCT: NCT07404514 · ULNEER · 2025-A02482-47

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗