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 (EVIDENCE)

Civil Hospices of Lyon

Status: Completed

Conditions: Pseudarthrosis

Treatments: Other: Cost evaluation; Other: Questionnaire

Study type: Observational

Funder types: Other

Identifiers

NCT03970941

69HCL19_0084

Details and patient eligibility

About

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.

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

8 participants in 2 patient groups

CERAMENT

Description:

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

Treatment:

Other: Questionnaire

Other: Cost evaluation

NO CERAMENT COMPARATIVE COHORT

Description:

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

Treatment:

Other: Cost evaluation