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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

NCT ID: NCT03970941

Last Updated: 2024-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

8 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-09-05

Study Completion Date

2022-12-21

Brief Summary

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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.

Detailed Description

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Conditions

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Pseudarthrosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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CERAMENT

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

Cost evaluation

Intervention Type OTHER

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

Questionnaire

Intervention Type OTHER

The quality of life of patients will be measured.

NO CERAMENT COMPARATIVE COHORT

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

Cost evaluation

Intervention Type OTHER

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

Interventions

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Cost evaluation

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

Intervention Type OTHER

Questionnaire

The quality of life of patients will be measured.

Intervention Type OTHER

Eligibility Criteria

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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

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Centre de Référence des Infections Ostéo-Articulaires complexes (CRIOAc) - Hôpital de la Croix-Rousse

Lyon, , France

Site Status

Countries

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France

Other Identifiers

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69HCL19_0084

Identifier Type: -

Identifier Source: org_study_id