Pseudoarthrosis of Bone Clinical Trial
Official title:
Septic Pseudarthrosis Of Long Bone : Experience In A Regional Reference Center
| NCT number | NCT03620305 |
| Other study ID # | 18-078 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | April 1, 2018 |
| Est. completion date | December 30, 2018 |
| Verified date | February 2019 |
| Source | Hospices Civils de Lyon |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
Description of septic pseudarthrosis with chirurgical treatment in two steps (first step : Implementation of cement, second step : bone reconstruction, with or without device)
| Status | Completed |
| Enrollment | 20 |
| Est. completion date | December 30, 2018 |
| Est. primary completion date | December 30, 2018 |
| Accepts healthy volunteers | |
| Gender | All |
| Age group | 18 Years to 100 Years |
| Eligibility |
Inclusion Criteria: - patients having septic pseudarthrosis of long bone treated at the CRIOAc LYON Exclusion Criteria: |
| Country | Name | City | State |
|---|---|---|---|
| France | Hospices Civils de Lyon | Lyon |
| Lead Sponsor | Collaborator |
|---|---|
| Hospices Civils de Lyon |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Description of treatment of septic pseudarthrosis : chirurgical treatment - rate of use of this type of chirurgical treatment among patients with septic pseudarthrosis | Description of treatment of septic pseudarthrosis : chirurgical treatment | Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption) | |
| Secondary | Description of treatment of septic pseudarthrosis : medical treatment - duration of treatment in patients having sepstic pseudarthrosis | Description of treatment of septic pseudarthrosis : medical treatment | Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption) | |
| Secondary | Treatment failure : rate of failure with this 2 times chirurgical treatment | Treatment failure is defined by local clinical and/or microbiological relapse; and/or need for additional surgery; death of septic origin | Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption) |
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