Analysis of Risk Factors for Recurrence of Periprosthetic Infection in Megaprostheses Implanted for Sarcoma of Bone

NCT06784414 | Completed

• 1 other identifier: MEGAINF
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 2

Brief Summary

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

PJI

Keywords

megaprosthesis

Outcome Measures

Primary Outcomes (1)

• Identification of predictive factors for infection recurrence in patients with PJI: analysis of demographic, prognostic and treatment data.

  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.

  Data covering the period 2010-2020.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All participants meeting the inclusion criteria, processed from 2010 to 2020, were included.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (2)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

Location

A.O.U Città della Salute e della Scienza di Torino

Torino, 10126, Italy

Location

Study Officials

• Andrea Sambri, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2024
• First Posted: January 20, 2025
• Study Start: February 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: January 20, 2025

Record last verified: 2024-10

Locations

IT (2)