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

NCT03970941 | Completed

• 1 other identifier: 69HCL19_0084
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Pseudarthrosis

Outcome Measures

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)

  24 months maximum

Study Arms (2)

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

Cost evaluation OTHER

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

CERAMENT; NO CERAMENT COMPARATIVE COHORT

Questionnaire OTHER

The quality of life of patients will be measured.

CERAMENT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

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

Lyon, 69317, France

Location

MeSH Terms

Conditions

Pseudarthrosis

Interventions

Cost-Benefit Analysis; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Fractures, Ununited; Fractures, Bone; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Costs and Cost Analysis; Economics; Health Care Economics and Organizations; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2019
• First Posted: June 3, 2019
• Study Start: September 5, 2019
• Primary Completion: December 21, 2022
• Study Completion: December 21, 2022
• Last Updated: December 9, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)