Critical-size Bone Defect
Conditions
Keywords
Bone transport, Critical-size bone defects, Distraction osteogenesis, Induced-membrane technique, Masquelet technique
Brief summary
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
OTHERData 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).
Sponsors
University Hospital, Bordeaux
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of radiological consolidation | From enrollment to 36 months after | 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
| Measure | Time frame | Description |
|---|---|---|
| Functional outcomes : score MSTS | Baseline, 12 months, 24 months and 36 months | 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 | Baseline, 3 months, 6 months, 12 months, 24 months and 36 months | Time from initial reconstructive surgery to full weight-bearing without assistive devices, as assessed during routine clinical follow-up. |
| . Functional outcomes : score LEFS | Baseline, 12 months, 24 months and 36 months | 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. | Baseline, 12 months, 24 months and 36 months | Functional recovery assessed using Paley-Maar score. This score is defined from "excellent" to "poor"in fonction of pain, autonomous, .... |
| Quality of life | Baseline, 12 months, 24 months and 36 months | 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. |
| Adverse events and complications | 3 months, 6 months, 12 months, 24 months and 36 months | Occurrence and type of adverse events and complications, including infections, mechanical failures, nonunion, and need for revision surgery. |
| Bone consolidation rate | From enrollment to 36 months after | Proportion of patients achieving radiological bone consolidation, defined as healing of at least 3 of 4 cortices on standard anteroposterior and lateral radiographs. |
Countries
France
Contacts
CONTACTBenjamin BOUYER, PROF
CONTACTRomain HUGUET
PRINCIPAL_INVESTIGATORBenjamin BOUYER, PROF
University Hospital, Bordeaux
Outcome results
None listed