An interventional study of Data collection and self-administered questionnaire. in Critical-size Bone Defect, sponsored by University Hospital, Bordeaux. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-05.
Sponsored by University Hospital, Bordeaux · Not applicable, Interventional, and Other
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.
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.
University Hospital, Bordeaux is the lead sponsor of 783 studies on the registry; 188 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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:
Exclusion Criteria:
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.
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.
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).
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.
Time frame: From enrollment to 36 months after
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.
Time frame: 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.
Time frame: 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.
Time frame: 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, ....
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From enrollment to 36 months after
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University Hospital, Bordeaux