Ulnar Longitudinal DeficiencyULNEERNCT07404514
Longitudinal Ulnar Deficit (ULNEER)
An observational study of Ulnar Longitudinal Deficiency and Ulnar Hand Deformity, run by Hopitaux de Saint-Maurice at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Ulnar Longitudinal Deficiency, Ulnar Hand Deformity
- How many people
- 28 participants
- Where
- 1 siteFrance
- Study dates
- 12 Feb 2026to Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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
Who cannot join
- Non-French-speaking patient
- No preoperative or postoperative assessment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpitaux Paris Est Val-de-Marne - Centre de Référence des Malformations des Membres
Saint-Maurice, 94410
Adrien AL Leluc, MD, +33 6 06 99 96 74, Adrien.leluc@gmail.com
Adrien AL Leluc, MD
About this study
Official title: 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.
Read more
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.
- Keywords
- Ulnar longitudinal deficit, Upper limb deficiency, Pediatric upper limb, Occupational therapy, ABILHAND-Kids, PROMIS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline to study completion (up to 10 months)
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: From baseline to study completion (up to 10 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2026
- Study start12 Feb 2026
- Primary completion30 May 2026
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulnar Longitudinal DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hopitaux de Saint-Maurice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07404514
- Sponsor's protocol ID
- ULNEER
- Other IDs
- 2025-A02482-47
- Acronym
- ULNEER
- Status last verified
- Aug 2026
- First submitted
- 2 Feb 2026
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective and Retrospective Observational Study on Longitudinal Ulnar Deficit: Analysis of Existing Medical Data and Parental Questionnaires
- ClinicalTrials.gov ID
- NCT07404514
- Acronym / sponsor ID
- ULNEER / ULNEER
- Keywords
- Ulnar longitudinal deficit, Upper limb deficiency, Pediatric upper limb, Occupational therapy, ABILHAND-Kids, PROMIS
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Hopitaux de Saint-MauriceUniversity, hospital or other
- Study start
- 12 Feb 2026 (actual)
- Primary completion
- 30 May 2026 (actual)
- Study completion
- Sep 2026 (estimated)
- First posted
- 11 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Non-French-speaking patient
- No preoperative or postoperative assessment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
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.
3 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Individual participant dataSharing planned: No. 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ulnar Longitudinal Deficiency and Ulnar Hand Deformity, run by Hopitaux de Saint-Maurice at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Auriane AS SLAMA (0143967556, auriane.slama@ght94n.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026; AzTrials last refreshed its copy on 27 Oct 2026.