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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 8 (actual)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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

Interventions

Type	Name	Description
OTHER	Cost evaluation	The cost for the hospital of the strategy of management will be evaluated.
OTHER	Questionnaire	The quality of life of patients will be measured.

Timeline

• Start date: 2019-09-05
• Primary completion: 2022-12-21
• Completion: 2022-12-21
• First posted: 2019-06-03
• Last updated: 2024-12-09

Locations

1 site across 1 country: France