Critical-size Bone DefectEPSOCOTNCT07389681
Management of Bone Loss in Orthopaedic Surgery Using the Masquelet Technique or Transport Nails
A study testing Data collection and self-administered questionnaire. in people with Critical-size Bone Defect, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical-size Bone Defect
- What is being tested?
- Data collection and self-administered questionnaire.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteFrance
- Study dates
- 27 Apr 2026to Mar 2034
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Romain HUGUET contact
France1 site, 1 recruiting
- Recruiting
CHU de Bordeaux
Bordeaux, 33000
Benjamin BOUYER, PROF, +335 56 79 87 18, b.bouyer@chu-bordeaux.fr
Anaïs DELGOVE, MD
About this study
Official title: Evaluation of the 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.
Read the detailed description
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.
- Conditions
- Critical-size Bone Defect
- Being tested
- Data collection and self-administered questionnaire.
- Keywords
- Bone transport, Critical-size bone defects, Distraction osteogenesis, Induced-membrane technique, Masquelet technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collection and self-administered questionnaire.Other
Exhaustive 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).
| Study group | Role | What they receive |
|---|---|---|
| Masquelet's method | Other | 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 Masquelet technic is envisaged Receives: Other: Data collection and self-administered questionnaire. |
| Transport nail | Other | 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 is envisaged Receives: Other: Data collection and self-administered questionnaire. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of radiological consolidation
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.
Measured: From enrollment to 36 months after
Secondary outcomes (7)
Functional outcomes : score MSTS
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.
Measured: Baseline, 12 months, 24 months and 36 months
Time to full weight-bearing
Time from initial reconstructive surgery to full weight-bearing without assistive devices, as assessed during routine clinical follow-up.
Measured: Baseline, 3 months, 6 months, 12 months, 24 months and 36 months
. Functional outcomes : score LEFS
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.
Measured: Baseline, 12 months, 24 months and 36 months
Functional outcomes : paley Marr score.
Functional recovery assessed using Paley-Maar score. This score is defined from "excellent" to "poor"in fonction of pain, autonomous, ....
Measured: Baseline, 12 months, 24 months and 36 months
Quality of life
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.
Measured: Baseline, 12 months, 24 months and 36 months
Adverse events and complications
Occurrence and type of adverse events and complications, including infections, mechanical failures, nonunion, and need for revision surgery.
Measured: 3 months, 6 months, 12 months, 24 months and 36 months
Bone consolidation rate
Proportion of patients achieving radiological bone consolidation, defined as healing of at least 3 of 4 cortices on standard anteroposterior and lateral radiographs.
Measured: From enrollment to 36 months after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study start27 Apr 2026
- Primary completionMar 2029 (estimated)
- Study completionMar 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical-size Bone DefectStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benjamin BOUYER, PROF, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07389681
- Sponsor's protocol ID
- CHUBX2025/061
- Acronym
- EPSOCOT
- Status last verified
- Jun 2026
- First submitted
- 28 Jan 2026
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Management of Bone Loss in Orthopaedic Surgery Using the Masquelet Technique or Transport Nails
- ClinicalTrials.gov ID
- NCT07389681
- Acronym / sponsor ID
- EPSOCOT / CHUBX2025/061
- Conditions
- Critical-size Bone Defect
- Keywords
- Bone transport, Critical-size bone defects, Distraction osteogenesis, Induced-membrane technique, Masquelet technique
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 27 Apr 2026 (actual)
- Primary completion
- Mar 2029 (estimated)
- Study completion
- Mar 2034 (estimated)
- First posted
- 5 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.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Masquelet's method | Other | Other: Data collection and self-administered questionnaire.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 Masquelet technic is envisaged |
| Transport nail | Other | Other: Data collection and self-administered questionnaire.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 is envisaged |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
Key exclusion criteria (8 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data collection and self-administered questionnaire.Exhaustive 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). | Other | Masquelet's method, Transport nail |
Primary outcome
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.
7 secondary outcomes
Functional outcomes : score MSTS
Time frame: Baseline, 12 months, 24 months and 36 months
Time to full weight-bearing
Time frame: Baseline, 3 months, 6 months, 12 months, 24 months and 36 months
. Functional outcomes : score LEFS
Time frame: Baseline, 12 months, 24 months and 36 months
Functional outcomes : paley Marr score.
Time frame: Baseline, 12 months, 24 months and 36 months
Quality of life
Time frame: Baseline, 12 months, 24 months and 36 months
Adverse events and complications
Time frame: 3 months, 6 months, 12 months, 24 months and 36 months
Bone consolidation rate
Time frame: From enrollment to 36 months after
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 5 Jun 2026.
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.
Romain HUGUET contact
Benjamin BOUYER, PROF principal investigator
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Data collection and self-administered questionnaire. in people with Critical-size Bone Defect, run by University Hospital, Bordeaux 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 7 inclusion and 8 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 5 Jun 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 Benjamin BOUYER, PROF (+335 56 79 87 18, b.bouyer@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of radiological consolidation (time frame: From enrollment to 36 months after). 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 5 Jun 2026.