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

Completed

• Conditions: Pseudarthrosis
• Interventions: Other: Cost evaluation; Other: Questionnaire

• Registration Number: NCT03970941
• Lead Sponsor: Hospices Civils de Lyon

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-29
• Study First Submitted QC: 2019-05-29
• Study First Posted: 2019-06-03
• Study Start: 2019-09-05
• Primary Completion: 2022-12-21
• Study Completion: 2022-12-21
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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

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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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CERAMENT	Cost evaluation	Patients having a septic pseudarthrosis managed with two-stage treatment (Masquelet Technique) with CERAMENT®.
CERAMENT	Questionnaire	Patients having a septic pseudarthrosis managed with two-stage treatment (Masquelet Technique) with CERAMENT®.
NO CERAMENT COMPARATIVE COHORT	Cost evaluation	Patients having had a septic pseudarthrosis managed with two-stage treatment (only Masquelet Technique) without CERAMENT®.

Primary Outcome Measures

Name	Time	Method
Cost evaluation	24 months maximum	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)

Trial Locations

Locations (1)

Centre de Référence des Infections Ostéo-Articulaires complexes (CRIOAc) - Hôpital de la Croix-Rousse; 🇫🇷 Lyon, France