Ignite Creation Date:
2025-12-25 @ 2:14 AM
Ignite Modification Date:
2025-12-26 @ 12:43 AM
Study NCT ID:
NCT06699160
Status:
WITHDRAWN
Last Update Posted:
2025-11-25
First Post:
2024-11-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Refobacin Revision-3 Bone Cement Post-Market Study
Sponsor:
Zimmer Biomet
Organization:
Study Overview
Official Title:
Post Market Clinical Follow-up Study on the Refobacin Revision-3 Bone Cement and Its Instrumentation
Status:
WITHDRAWN
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was discontinued upon availability of relevant data through bespoke reporting, which fulfilled the study's primary objectives
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
* 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.
Patients will be enrolled prospectively or retrospectively (minimum 3 years after their surgery, depending on the availability of the data.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: