PseudarthrosisEVIDENCENCT03970941
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
An observational study of Pseudarthrosis, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pseudarthrosis
- What is being tested?
- Cost evaluation and Questionnaire
- How many people
- 8 participants
- Where
- 1 siteFrance
- Study dates
- 5 Sep 2019to 21 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients having / having had a septic pseudarthrosis manage with two stage exchange (Masquelet technique)
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
France1 site
Centre de Référence des Infections Ostéo-Articulaires complexes (CRIOAc) - Hôpital de la Croix-Rousse
Lyon, 69317
About this study
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
- Being tested
- Cost evaluation, Questionnaire
- Medical subject headings
- Pseudarthrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cost evaluationOther
The cost for the hospital of the strategy of management will be evaluated.
QuestionnaireOther
The quality of life of patients will be measured.
| Study group | Role | What they receive |
|---|---|---|
| CERAMENT | Patients having a septic pseudarthrosis managed with two-stage treatment (Masquelet Technique) with CERAMENT®. Receives: 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®. Receives: Other: Cost evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 24 months maximum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2019
- Study start5 Sep 2019
- Primary completion21 Dec 2022
- Study completion21 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PseudarthrosisStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03970941
- Sponsor's protocol ID
- 69HCL19_0084
- Acronym
- EVIDENCE
- Status last verified
- Dec 2024
- First submitted
- 29 May 2019
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03970941
- Acronym / sponsor ID
- EVIDENCE / 69HCL19_0084
- Conditions
- Pseudarthrosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 5 Sep 2019 (actual)
- Primary completion
- 21 Dec 2022 (actual)
- Study completion
- 21 Dec 2022 (actual)
- First posted
- 3 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CERAMENT | – | Other: Cost evaluation, Other: QuestionnairePatients having a septic pseudarthrosis managed with two-stage treatment (Masquelet Technique) with CERAMENT®. |
| NO CERAMENT COMPARATIVE COHORT | – | Other: Cost evaluationPatients having had a septic pseudarthrosis managed with two-stage treatment (only Masquelet Technique) without CERAMENT®. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients having / having had a septic pseudarthrosis manage with two stage exchange (Masquelet technique)
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cost evaluationThe cost for the hospital of the strategy of management will be evaluated. | Other | CERAMENT, NO CERAMENT COMPARATIVE COHORT |
| QuestionnaireThe quality of life of patients will be measured. | Other | CERAMENT |
Primary outcome
Cost evaluation
Time frame: 24 months maximum
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- Individual participant dataSharing planned: No
Related trials for Pseudarthrosis
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SPECT/CT Bone Scan Quantification Surgery
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Collecting Bone Graft During Spinal Decompression and Posterolateral Lumbar Fusion to Better Define Bone Making Cells
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A Study to Assess How Effective and Safe NVD003 is for Treating Patients With Congenital Pseudarthrosis of the Tibia.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pseudarthrosis, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cost evaluation (time frame: 24 months maximum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2024.