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CompletedNCT03970941EVIDENCEUpdated Dec 9, 2024

Two-stage Treatment of Large Bone Defects With Cerament® G and Cerament® V Plus Auto and/or Allograft Using the Masquelet Technique as Salvage Therapy After Bone Resection in Patients With Septic Pseudarthrosis

An observational study in Pseudarthrosis, sponsored by Hospices Civils de Lyon. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-09.

Sponsored by Hospices Civils de Lyon · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
8
Ages
18 Years and older
Sex
All
01

Study summary

Septic pseudarthrosis of long bones are complications that can unfortunately occur after the consolidation of a fracture and some situations present risks of superinfection, persistent infection or mechanical failure (30-40% risk of complications) that can lead to amputation.

A possible saving situation used by CRIOAC ("Centre de Référence des Infections Ostéo-Articulaires Complexes") is the use of a bone substitute impregnated with an antibiotic allowing a high local concentration of this antibiotic.

The aim of this study is to evaluate the cost of management of septic pseudarthrosis with two-stage treatment and CERAMENT® and the quality of life for this patients.

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Conditions studied

  • Pseudarthrosis

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03

In context

Pseudarthrosis

41 studies on the registry are indexed under Pseudarthrosis; 7 are open to participants now.

This study's enrollment of 8 is below the median of 60 across 16 observational studies indexed under Pseudarthrosis.

Browse Pseudarthrosis studies →

Lead sponsor

Hospices Civils de Lyon is the lead sponsor of 1,866 studies on the registry; 448 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Patients having / having had a septic pseudarthrosis manage with two stage exchange (Masquelet technique)

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • age ≥ 18 years old
  • Diagnosis of septic pseudarthrosis
  • septic pseudarthrosis managed by the surgical technique using the CERAMENT bone substitute combined with an autograft / allograft by the Masquelet technique OR, for the comparative cohort: septic pseudarthrosis on long bone previously managed by the masquelet method without CERAMENT®
  • Medico-surgical management within the CRIOAC ("Centre de Référence des Infections Ostéo-Articulaires Complexes") of the Croix-Rousse hospital in Lyon
  • Patient who was informed and did not object to participate in the study

Exclusion criteria

Exclusion Criteria:

  • Patient with a disability (deafness, language disorders) or whose mental or cognitive state does not allow to be informed and to express his opposition if necessary.
  • Patient with a disability (deafness, language impairment) or whose mental or cognitive state does not allow to understand the questions in the quality of life questionnaire
  • Patient participating in another quality of life study
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
8 participants (actual)
Patient registry
No

Groups and cohorts

  • CERAMENT

    Patients having a septic pseudarthrosis managed with two-stage treatment (Masquelet Technique) with CERAMENT®.

    Other: Cost evaluation · Other: Questionnaire

  • NO CERAMENT COMPARATIVE COHORT

    Patients having had a septic pseudarthrosis managed with two-stage treatment (only Masquelet Technique) without CERAMENT®.

    Other: Cost evaluation

Interventions

  • OtherCost evaluation

    The cost for the hospital of the strategy of management will be evaluated.

  • OtherQuestionnaire

    The quality of life of patients will be measured.

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What researchers measure

Primary outcomes

  1. Cost evaluation

    Estimation of the cost of care from the point of view of the hospital This estimation will be measured at the end of patient follow-up (usually between 12 and 24 months after antibiotic therapy disruption)

    Time frame: 24 months maximum

07

Study locations

1 site
  • Centre de Référence des Infections Ostéo-Articulaires complexes (CRIOAc) - Hôpital de la Croix-Rousse
    Lyon, 69317, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03970941
Responsible party
Sponsor
First posted
Jun 3, 2019
Start date
Sep 5, 2019
Primary completion
Dec 21, 2022
Completion
Dec 21, 2022
Last update
Dec 9, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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