Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:14 AM
Ignite Modification Date:
2025-12-25 @ 2:14 AM
NCT ID:
NCT06699160
Brief Summary:
The goal of this post-market study is to confirm the safety, performance and clinical benefits of the Refobacin Revision-3 Bone Cement when used in knee or hip revision surgeries. This will be done by collecting information on:
* removal of any metal components of the hip or knee implants used in combination with the cement
* frequency and incidence of adverse events
* overall pain and functional performance, subject quality of life, and radiographic parameters
Detailed Description:
Multicenter, retrospective and prospective, non-controlled Post-Market Clinical Follow-Up (PMCF) study involving orthopedic surgeons skilled in knee or hip arthroplasty procedures.
Patients will be enrolled prospectively or retrospectively (minimum 3 years after their surgery, depending on the availability of the data.
Study:
NCT06699160
Study Brief:
Protocol Section:
NCT06699160