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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Bordeaux

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Data collection and self-administered questionnaire.

    Other intervention

    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).

Treatment groups

250 Participants
are divided into 2 treatment groups
Group A: Masquelet's methodOther 1 intervention
Group B: Transport nailOther 1 intervention

Trial outcomes

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.

Time frame
From enrollment to 36 months after

Secondary outcomes

1

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
2

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
3

. 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
4

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

Other outcomes

Sponsors and contacts

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