Longitudinal Ulnar Deficit (ULNEER) (ULNEER)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Ulnar Hand Deformity; Ulnar Longitudinal Deficiency

• Study Type: Observational
• Enrollment (Estimated): 28

Contacts and Locations

• Study Contact: Name: Auriane AS SLAMA; Phone Number: 0143967556; Email: auriane.slama@ght94n.fr

Study Locations

• France
  • Saint-Maurice, France, 94410
    • Hôpitaux Paris Est Val-de-Marne - Centre de Référence des Malformations des Membres
    • Contact: Adrien AL Leluc, MD; Phone Number: +33 6 06 99 96 74; Email: Adrien.leluc@gmail.com
    • Principal Investigator: Adrien AL Leluc, MD

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

The study population consists of children and adolescents aged 3 to 18 years diagnosed with ulnar longitudinal deficiency, either unilateral or bilateral.

Participants are followed at a tertiary referral center for upper limb malformations and have available medical records allowing retrospective data extraction. Parent-reported outcome measures are collected prospectively as part of the study without modifying standard clinical care.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Ulnar Longitudinal Deficiency Observational Cohort; This arm represents a non-interventional observational cohort of children and adolescents with ulnar longitudinal deficiency. No intervention is assigned as part of the study. Clinical, radiological, and rehabilitation data are collected retrospectively from existing medical records and prospectively through parent-reported outcome questionnaires (PROMIS and ABILHAND-Kids-CP), without any modification of standard clinical care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Upper limb function and health-related quality of life (PROMIS Upper Extremity and ABILHAND-Kids)	Upper limb function and health-related quality of life will be assessed using validated parent-reported outcome measures: The Pediatric Outcomes Measurement Information System (PROMIS) Upper Extremity Pediatric questionnaire. PROMIS scores are standardized T-scores with a mean of 50 and a standard deviation of 10 in the reference population. Scores typically range from approximately 0 to 100, with higher scores indicating better upper limb function.; The ABILHAND-Kids questionnaire (Assessment of Manual Ability for Children). ABILHAND-Kids scores are converted into a scaled measure ranging from 0 to 100, with higher scores indicating better manual ability.	From baseline to study completion (up to 10 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Upper limb functional ability score	Upper limb functional ability will be assessed using the ABILHAND-Kids questionnaire (Assessment of Manual Ability for Children). Scores are converted into a scaled measure ranging from 0 to 100, with higher scores indicating better manual ability.	From baseline to study completion (up to 10 months)
Pediatric upper limb function	Upper limb function will be assessed using the Pediatric Outcomes Measurement Information System (PROMIS) Upper Extremity Pediatric questionnaire. PROMIS scores are standardized T-scores with a mean of 50 and a standard deviation of 10 in the reference population. Scores typically range from approximately 0 to 100, with higher scores indicating better upper limb function.	From baseline to study completion (up to 10 months)
Pediatric health-related quality of life	Health-related quality of life will be assessed using the Pediatric Outcomes Measurement Information System (PROMIS) Pediatric Global Health questionnaire. PROMIS scores are standardized T-scores with a mean of 50 and a standard deviation of 10 in the reference population. Scores typically range from approximately 0 to 100, with higher scores indicating better health-related quality of life.	From baseline to study completion (up to 10 months)

Collaborators and Investigators

• Sponsor: Hopitaux de Saint-Maurice

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: February 2, 2026
• First Submitted That Met QC Criteria: February 9, 2026
• First Posted (Actual): February 11, 2026

Study Record Updates

• Last Update Posted (Actual): February 13, 2026
• Last Update Submitted That Met QC Criteria: February 11, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Occupational therapy; PROMIS; Ulnar longitudinal deficit; Upper limb deficiency; Pediatric upper limb; ABILHAND-Kids
• Other Study ID Numbers: ULNEER; 2025-A02482-47 (Other Identifier: Agence nationale de sécurité du médicament et des produits de santé)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared due to the small sample size, the pediatric population involved, and the need to ensure participant confidentiality in accordance with applicable data protection regulations.

Drug and device information, study documents

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