CHU de Bordeaux
Bordeaux, 33000, France
Location status: Recruiting
Recruiting
NCT Number: NCT07389681
Management of Bone Loss in Orthopaedic Surgery Using the Masquelet Technique or Transport Nails
This is a single-center prospective observational study comparing two techniques for reconstructing bone loss in the lower limbs. The aim of the study was to compare the results of reconstructions using the Masquelet technique with reconstructions using electromagnetic transport nails. The primary endpoint was time to bone healing. This study is the first prospective descriptive study of electromagnetic transport nails.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
Segmental bone defects pose a major challenge in orthopaedics due to various causes like trauma, oncology resections, or chronic osteomyelitis. Reconstruction techniques are complex, with Masquelet's method being the most widely used in France, despite mixed outcomes and complications. A novel electromagnetic bone transport technique via intramedullary nailing has emerged as a promising alternative. The primary goal of the study is to compare consolidation times between these two approaches for metaphyseal-diaphyseal bone loss in the lower limbs. Secondary objectives include assessing patient demographics, functional outcomes, quality of life, hospital stays, and adverse events.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Patient ≥ 18 years
- Minor patient, able to consent to data collection, with the consent of the owner(s)
- Patient consulting for a medical reason involving a loss of bone substance in the lower limb in an investigating centre linked to one of these aetiologies for which a reconstruction procedure using a transport nail or Masquelet technique is envisaged:
- Tumour pathologies requiring
- Septic or aseptic pseudarthrosis
- Traumatic pathology
- Infectious pathologies
Exclusion criteria
- Patients under guardianship or curatorship,
- Individuals deprived of their liberty by judicial or administrative decision,
- Individuals receiving involuntary psychiatric care requiring the consent of their legal representative,
- Individuals unable to express their consent,
- Individuals under legal protection,
- Patients with an indication for bone reconstruction using a technique other than the Masquelet technique and nail transport,
- Patients not covered by a social security scheme,
- Patients ineligible for bone reconstruction due to their comorbidities
Treatment and study plan
Data collection and self-administered questionnaire.
OtherExhaustive collection of data in a health data warehouse: collection of clinical, radiological examinations (standard of care), functionals scores and self- administered questionnaire (quality of life).
Primary outcomes
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Rate of radiological consolidation
Time frame: From enrollment to 36 months after
Radiological consolidation is defined by an anteroposterior and lateral radiograph showing at least three out of four cortical plates consolidated. This assessment is performed during follow-up by the physician treating the patient and will be confirmed by an evaluation committee at a later stage.
Secondary outcomes
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Functional outcomes : score MSTS
Time frame: Baseline, 12 months, 24 months and 36 months
Functional recovery assessed using MSTS (Musculoskeletal Tumor Society Score). It is composed of 6 items , each item on a scale of 0 to 5, with a higher score indicating better function. The total score, ranging from 0 (maximum disability) to 30 (no disability), can be converted to a point scale from 0 to 100.
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Time to full weight-bearing
Time frame: Baseline, 3 months, 6 months, 12 months, 24 months and 36 months
Time from initial reconstructive surgery to full weight-bearing without assistive devices, as assessed during routine clinical follow-up.
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. Functional outcomes : score LEFS
Time frame: Baseline, 12 months, 24 months and 36 months
Functional recovery assessed using Lower Extremity Functional Scale (LEFS). It is composed of 20 items , each item on a scale of 0 to 4, with a higher score indicating better function and total score from 0 to 80.
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Functional outcomes : paley Marr score.
Time frame: Baseline, 12 months, 24 months and 36 months
Functional recovery assessed using Paley-Maar score. This score is defined from "excellent" to "poor"in fonction of pain, autonomous, ....
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Quality of life
Time frame: Baseline, 12 months, 24 months and 36 months
Health-related quality of life evaluated using the SF-36 questionnaire. This questionnaire is composed of 11 items and total score from 0 to 100.
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Adverse events and complications
Time frame: 3 months, 6 months, 12 months, 24 months and 36 months
Occurrence and type of adverse events and complications, including infections, mechanical failures, nonunion, and need for revision surgery.
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Bone consolidation rate
Time frame: From enrollment to 36 months after
Proportion of patients achieving radiological bone consolidation, defined as healing of at least 3 of 4 cortices on standard anteroposterior and lateral radiographs.
Study contacts
Contact information is provided by the study sponsor or research team.
Benjamin BOUYER, PROF
CONTACT
Romain HUGUET
CONTACT
Sponsors and collaborators
Lead sponsor
University Hospital, Bordeaux
Other
Registry information
Official study title
Evaluation of the Management of Bone Loss in Orthopaedic Surgery Using the Masquelet Technique or Transport Nails
Acronym: EPSOCOT
Important dates
- Study start
- 2026
- Primary completion
- 2029
- Study completion
- 2034
- First posted
- Feb 5, 2026
- Registry last updated
- Jun 5, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.