Induced Membrane Properties in Children and Adults
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: harvesting induced membrane.
- Who it may be relevant to
- Registry conditions: Bone Loss, Surgery. Basic parameters: 9 months — 60 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 →
Unsure about the terms? Read our patient guide →
Overview
Bone reconstruction in critical sized defect (CSD) remains a real challenge in orthopedic surgery in children and adults. The Masquelet technique is an innovative therapeutic technique, which offers a bone reconstruction in two steps, by the formation of an induced membrane (IM) around a polymethylmethacrylate (PMMA) spacer placed into the bone defect. After, PMMA removal, the cavity is filled with corticocancellous graft allowing bone healing. Up to date, all angiogenesis and osteogenic properties of IM remain unknown. The purpose of this study is to characterize angiogenesis and osteogenic properties of IM in children and adults.
Interventions
- Procedure harvesting induced membrane
The induced membrane will be harvested during the second step of the bone reconstruction.
Primary outcome measures
- Measure of the BMP2 concentration of the induced membrane by immunodetection [Time frame: one year (one year from day of surgery)]
Secondary outcome measures (2)
- BMP2 concentration of the induced membrane implanted in adults measured by immunodetection [Time frame: one year (one year from day of surgery)]
- BMP2 concentration of the induced membrane implanted in children measured by immunodetection [Time frame: one year (one year from day of surgery)]
Eligibility criteria
Inclusion criteria
- All patients treated at CHU Amiens-Picardie for bone critical sized defect treated using the induced membrane reconstruction technique.
- patients from 9 months to 60 years old
Exclusion criteria
- Patients managed by another reconstruction technique for critical sized defect
- Patients under guardianship, curators or deprived of liberty.
- Pregnant and nursing women.
- Patients who refused to participate in the study and to sign informed consent.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
France · 1 center
- CHU Amiens — Amiens
Identifiers
NCT: NCT04246944 · PI2018_843_0041