- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07254351
Analysis of the Biomechanical Impact of Lower Limb Length Inequality in PEDiatrics (ABILMI-PED)
Biomechanical Analysis of the Impact of Lower Limb Length Discrepancy on Hip and Lumbar Spine Joints in Children
Lower limb length discrepancy (LLD) is a frequent condition in pediatric orthopedics. Even moderate discrepancies can induce pelvic obliquity and compensatory scoliosis, modifying the distribution of joint loads at the hips and lumbar spine. These biomechanical imbalances are suspected to contribute to early degenerative conditions such as osteoarthritis or chronic low back pain.
The aim of this study is to quantify the biomechanical impact of LLD in children aged 10 to 15 years, using a combination of low dose biplanar EOS imaging (EOS Imaging System) and synchronized ground reaction force (GRF) measurements from integrated force platforms. These data will be used in musculoskeletal models developed in collaboration with the Biomechanics and Impact Mechanics Laboratory (LBMC, Laboratoire de Biomécanique et Mécanique des Chocs), enabling the estimation of hip joint and lumbar intervertebral disc loads.
This is the first pediatric study integrating EOS imaging, force platforms, and personalized musculoskeletal modeling to explore the mechanical consequences of LLD. The findings are expected to improve clinical reasoning and guide early therapeutic strategies.
Study Overview
Status
Intervention / Treatment
Detailed Description
Lower limb length discrepancy (LLD) is a frequent condition in pediatric orthopedics. Even moderate discrepancies can induce pelvic obliquity and compensatory scoliosis, modifying the distribution of joint loads at the hips and lumbar spine. These biomechanical imbalances are suspected to contribute to early degenerative conditions such as osteoarthritis or chronic low back pain.
The aim of this study is to quantify the biomechanical impact of LLD in children aged 10 to 15 years, using a combination of low dose biplanar EOS imaging (EOS Imaging System) and synchronized ground reaction force (GRF) measurements from integrated force platforms. These data will be used in musculoskeletal models developed in collaboration with the Biomechanics and Impact Mechanics Laboratory (LBMC, Laboratoire de Biomécanique et Mécanique des Chocs), enabling the estimation of hip joint and lumbar intervertebral disc loads.
A temporary orthopedic compensation (shoe lift) will also be tested to assess its immediate biomechanical effect. Participants will be evaluated at baseline (two EOS acquisitions: with and without compensation) and at 2 years (without compensation).
This is the first pediatric study integrating EOS imaging, force platforms, and personalized musculoskeletal modeling to explore the mechanical consequences of LLD. The findings are expected to improve clinical reasoning and guide early therapeutic strategies.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Thierry HAUMONT, MD, PhD
- Phone Number: +33 4 27 85 57 88
- Email: thierry.haumont@chu-lyon.fr
Study Contact Backup
- Name: Dimitri HERRERA-NATIVI
- Email: dimitri.herrera-nativi01@chu-lyon.fr
Study Locations
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-
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Bron, France, 69500
- Recruiting
- Hospices Civils de Lyon Service d'Orthopédie et de Traumatologie
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Contact:
- Thierry HAUMONT, Pr
- Phone Number: +33 04.27.85.57.88
- Email: thierry.haumont@chu-lyon.fr
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Principal Investigator:
- Thierry HAUMONT, Pr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
The study population will consist of approximately 100 pediatric patients (aged 10 to 15 years) presenting with an anatomical lower limb length discrepancy (LLD) greater than 5 mm, confirmed by clinical evaluation. Participants will be recruited consecutively during routine outpatient visits at the Pediatric Orthopedics Department of Hôpital Femme-Mère-Enfant (HFME), Hospices Civils de Lyon, Bron, France. This hospital is a tertiary referral center in pediatric orthopedics, receiving children from the Rhône-Alpes region and beyond.
All included patients will undergo EOS imaging as part of their standard clinical assessment for LLD, ensuring that the study is fully integrated within the regular care pathway. The cohort therefore represents a specialized clinical sample of children with LLD, rather than a general population or community-based sample.
Description
Inclusion Criteria:
- Children aged 10-15 years
- Anatomical LLD > 5 mm, clinically measured
- EOS imaging indicated by the pediatric orthopedic surgeon in routine care
- Ability to stand still for 30 seconds without assistance
- Covered by social security
- Parental consent and non-opposition obtained
Exclusion Criteria:
- - Functional or postural LLD without true anatomical discrepancy
- History of major pelvic or spinal surgery
- Severe neurological or orthopedic condition preventing standing (e.g. cerebral palsy, progressive myopathy)
- Fixed equinus deformity preventing plantar support
- Major lower limb deformity (severe genu varum/valgum)
- Contraindication or inability to undergo EOS imaging
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Children with lower limb length discrepancy (LLD)
Pediatric patients aged 10-15 years with an anatomical LLD > 5 mm, evaluated in the routine pediatric orthopedic care pathway.
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Low-dose biplanar radiographs of the whole body in standing position (EOS Imaging System).
At baseline, two EOS acquisitions will be performed in static standing position : one without compensation (natural position) and one with temporary orthopedic compensation (shoe lift under the shorter limb).
At 24 months, one EOS acquisition will be performed without compensation.
Each acquisition lasts a few seconds, with radiation exposure 5 to 10 times lower than conventional radiographs.
Ground reaction force (GRF) measurements obtained from a force platform integrated in the EOS cabin.
The platform records weight distribution and center of pressure during static standing posture.
Measurements are fully synchronized with EOS acquisitions, without additional time or discomfort for participants.
At baseline, GRF measurements will be collected in two conditions (with and without orthopedic compensation).
At 24 months, GRF measurements will be collected in the non-compensated condition.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Asymmetry of Hip Joint Contact Forces (%) in Static Standing
Time Frame: At baseline (Day 0, without compensation)
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Hip joint contact force asymmetry index (%): calculated as AI (%) = 100 × (F_long - F_short) / [(F_long + F_short)/2], where F_long and F_short are side-specific resultant hip joint contact forces (estimated by musculoskeletal modeling from EOS imaging and ground reaction force data).
Units: percent (%).Higher values indicate greater asymmetry.
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At baseline (Day 0, without compensation)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Thierry HAUMONT, MD, Hospices Civils de Lyon
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 69HCL25_0746
- 2025-A01923-46 (Other Identifier: ID-RCB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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