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OpenTrials
Completed

NCT Number: NCT03970941

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

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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Key information

Conditions

Pseudarthrosis Fractures, Bone Fractures, Ununited Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Lyon, 69317, France

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cost evaluation

Other

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

Questionnaire

Other

The quality of life of patients will be measured.

Primary outcomes

  1. Cost evaluation

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: EVIDENCE

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jun 3, 2019
Registry last updated
Dec 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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