Results of Silver-coated Resection Prostheses in the Treatment of Periprosthetic Knee Infections with Bone Deficiency

NCT06806449 | Completed

• 1 other identifier: MEGAPJI
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 3

Brief Summary

The goal of this observational study is to evaluate the infection control and mid-term survival of silver-coated articulated megaprosthetic and knee arthrodesis implants in PJI patients with bone stock deficiency and treated with two-stage protocol.

Conditions

PJI

Keywords

two-stage treatment; PJI; silver-coated

Outcome Measures

Primary Outcomes (1)

• Infection status

  absence of clinical radiological and/or laboratory signs of infection or infected.

  through study completion, an average of 1 year

Secondary Outcomes (1)

• Incidence of complications unrelated to prosthesis infection in the two different stages of the protocol, also analyzing the number of "first stage" repetitions

  Within 8 weeks and 24 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients treated at the Orthopedics and Traumatology Operating Unit of IRCCS Azienda Ospedaliero Universitaria di Bologna, Policlinico di S.Orsola and other national centers between January 2020 and December 2024 with silver-coated knee megaprosthesis in the two-stage treatment of knee PJI.

You may qualify if:

• Diagnosis of periprosthetic knee infection on primary or already revised implants
• Treatment of infection with two-stage protocol
• Placement of articulated knee megaprosthesis (distal femoral or proximal tibial resection) or arthrodesis, silver-coated.
• Clinical and radiographic follow-up obtained or obtainable greater than or equal to 24 months.
• Completeness of clinical-radiographic documentation
• Obtainment of informed consent
• Age\>=18 years

You may not qualify if:

• Unfit patients
• Patient with a history of oncology
• Patient with contraindications to taking radiographs at follow-up

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (3)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Bologna, 40138, Italy

Location

Azienda Ospedaliero Universitaria Careggi

Florence, Florence, 50134, Italy

Location

Azienda Ospedaliero Universitaria Pisana

Pisa, Pisa, 56126, 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: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2024
• First Posted: February 4, 2025
• Study Start: August 20, 2023
• Primary Completion: January 11, 2024
• Study Completion: January 11, 2024
• Last Updated: February 4, 2025

Record last verified: 2024-12

Locations

IT (3)