Management of Bone Loss in Orthopaedic Surgery Using the Masquelet Technique or Transport Nails (EPSOCOT)

University Hospital of Bordeaux

Status: Begins enrollment this month

Conditions: Critical-size Bone Defect

Treatments: Other: Data collection and self-administered questionnaire.

Study type: Interventional

Funder types: Other

Identifiers

NCT07389681

CHUBX2025/061

Details and patient eligibility

About

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.

Full 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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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250 participants in 2 patient groups

Masquelet's method

Other group

Description:

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

Treatment:

Other: Data collection and self-administered questionnaire.

Transport nail

Other group

Description:

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

Treatment:

Other: Data collection and self-administered questionnaire.