Management of Bone Loss in Orthopaedic Surgery Using the Masquelet Technique or Transport Nails
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Data collection and self-administered questionnaire..
- Who it may be relevant to
- Registry conditions: Critical-size Bone Defect. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of the Management of Bone Loss in Orthopaedic Surgery Using the Masquelet Technique or Transport Nails
Overview
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.
Interventions
- Other 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).
Primary outcome measures
- Rate of radiological consolidation [Time frame: From enrollment to 36 months after]
Secondary outcome measures (7)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
France · 1 center
- CHU de Bordeaux — Bordeaux
Identifiers
NCT: NCT07389681 · CHUBX2025/061