Clinical trial · Observational
Analysis of Risk Factors for Recurrence of Periprosthetic Infection in Megaprostheses Implanted for Sarcoma of Bone
NCT06784414CI-TRIAL-00084887completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this observational study is to collect a large and homogeneous case report of periprosthetic infections in megaprostheses in patients with a history of bone sarcoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| PJI | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Identification of predictive factors for infection recurrence in patients with PJI: analysis of demographic, prognostic and treatment data.
- timeFrame
- Data covering the period 2010-2020.
- description
- Demographic information on disease definition, prognosis, treatments provided and outcomes will be summarised using descriptive methods. treatments provided and outcomes, will be summarised using descriptive methods. In in particular, categorical variables will be summarised by means of relative frequency estimation and 95% confidence intervals; continuous variables will be summarised by means of mean and standard deviation, median and range. standard deviation, median and interquartile range. Correlations between variables will be investigated: by means of contingency tables and calculation of the chi-square calculation (applying correction for continuity and/or exact test when necessary) for categorical categorical variables; comparison of means (t-test for paired and unpaired data or non-parametric analogues non-parametric when indicated) for variables distributed on an interval scale.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with PJI caused by a megaprosthesis, implanted for a primary sarcoma of bone; * Age \>= 18 years at the time of diagnosis; * Megaprosthesis site: proximal humerus, proximal femur, total femur, distal femur, tibia proximal; * Prosthetic revision in two stages; * Obtaining informed consent for the study Exclusion Criteria: * Early infection (within 6 weeks after implantation of the prosthesis); * Recurrence of infection; * Follow-up \< 12 months after prosthetic re-implantation; * Reconstruction other than a megaprosthesis (e.g., bone graft, composite prosthesis)
References
Publications (0)
Data not yet available
No reference posted for this study.