NCT07389681

Brief 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. The primary endpoint was time to bone healing. This study is the first prospective descriptive study of electromagnetic transport nails.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
95mo left

Started Apr 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress1%
Apr 2026Mar 2034

First Submitted

Initial submission to the registry

January 28, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 5, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2029

Expected
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2034

Last Updated

April 28, 2026

Status Verified

April 1, 2026

Enrollment Period

2.9 years

First QC Date

January 28, 2026

Last Update Submit

April 22, 2026

Conditions

Critical-size Bone Defect

Keywords

Bone transportCritical-size bone defectsDistraction osteogenesisInduced-membrane techniqueMasquelet technique

Outcome Measures

Primary Outcomes (1)

  • 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.

    From enrollment to 36 months after

Secondary Outcomes (7)

  • Functional outcomes : score MSTS

    Baseline, 12 months, 24 months and 36 months

  • Time to full weight-bearing

    Baseline, 3 months, 6 months, 12 months, 24 months and 36 months

  • . Functional outcomes : score LEFS

    Baseline, 12 months, 24 months and 36 months

  • Functional outcomes : paley Marr score.

    Baseline, 12 months, 24 months and 36 months

  • Quality of life

    Baseline, 12 months, 24 months and 36 months

  • +2 more secondary outcomes

Study Arms (2)

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

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

Other: Data collection and self-administered questionnaire.

Interventions

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).

Masquelet's methodTransport nail

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Bordeaux

Bordeaux, 33000, France

Location

MeSH Terms

Interventions

Data Collection

Intervention Hierarchy (Ancestors)

Epidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Benjamin BOUYER, PROF

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Benjamin BOUYER, PROF

CONTACT

+335 56 79 87 18b.bouyer@chu-bordeaux.fr

Romain HUGUET

CONTACT

romain.huguet@chu-bordeaux.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2026

First Posted

February 5, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

March 1, 2029

Study Completion (Estimated)

March 1, 2034

Last Updated

April 28, 2026

Record last verified: 2026-04

Locations

FR(1)