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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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03970941
Acronym
EVIDENCE
Enrollment
8
Registered
2019-06-03
Start date
2019-09-05
Completion date
2022-12-21
Last updated
2024-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pseudarthrosis

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.

Interventions

OTHERQuestionnaire

The quality of life of patients will be measured.

OTHERCost evaluation

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

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frameDescription
Cost evaluation24 months maximumEstimation 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)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026