CompletedNot Applicable

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

France8 participantsStarted 2019-09-05

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Cost evaluation

Timeframe: 24 months maximum

Trial details

NCT IDNCT03970941

SponsorHospices Civils de Lyon

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-12-21

View on ClinicalTrials.gov More Pseudarthrosis trials