About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient ≥ 18 years
Minor patient, able to consent to data collection, with the consent of the owner(s)
Tumour pathologies requiring
Septic or aseptic pseudarthrosis
Disqualifiers
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,
Trial design
Parallel
Treatments tested in this trial
Data collection and self-administered questionnaire.
Other interventionExhaustive 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).
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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 to full weight-bearing
Time from initial reconstructive surgery to full weight-bearing without assistive devices, as assessed during routine clinical follow-up.
. 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.
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, ....
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