Ignite Creation Date:
2025-12-24 @ 5:56 PM
Ignite Modification Date:
2025-12-24 @ 5:56 PM
Study NCT ID:
NCT04348968
Status:
TERMINATED
Last Update Posted:
2021-04-05
First Post:
2020-04-14
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Maxera Large Cups - Canada
Sponsor:
Zimmer Biomet
Organization:
Study Overview
Official Title:
Retrospective and Prospective Post-Market Clinical Follow-up Study to Provide Safety, Performance and Clinical Benefits Data of the Zimmer® Maxera™ Cup (Implants and Instrumentation)
Status:
TERMINATED
Status Verified Date:
2021-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The notified body does not require data anymore and recruitment did not start. The study was thus terminated after approval from the investigator and the local ethical committee.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Maxera Canada
Brief Summary:
This study is monocentric, retrospective and prospective, non-controlled, consecutive series Post-Market Clinical Follow-up Study to Provide Safety, Performance and Clinical Benefits Data of the Largest Zimmer® Maxera™ Cup (Implants and Instrumentation)
Detailed Description:
The Zimmer Maxera Cup is a monoblock construct that consists of a preassembled shell and liner. The ceramic liner articulates with a ceramic femoral head for a ceramic-on-ceramic large diameter head articulation.
The BIOLOX® delta ceramic liner (insert) is preassembled to lock into the tapered shell's cavity and articulate with BIOLOX OPTION ceramic femoral heads, sizes 32, 36, 40, 44, and 48 mm and standard BIOLOX delta ceramic femoral head sizes 32, 36, and 40 mm.
This is a single center post-market clinical evaluation. A consecutive series of 32 patients treated with a Maxera Cup (outer diameter 64 mm or 66 mm) between Nov 2011 and Feb 2018 will be identified and invited to participate in the study.
The BIOLOX® delta ceramic liner (insert) is preassembled to lock into the tapered shell's cavity and articulate with BIOLOX OPTION ceramic femoral heads, sizes 32, 36, 40, 44, and 48 mm and standard BIOLOX delta ceramic femoral head sizes 32, 36, and 40 mm.
This is a single center post-market clinical evaluation. A consecutive series of 32 patients treated with a Maxera Cup (outer diameter 64 mm or 66 mm) between Nov 2011 and Feb 2018 will be identified and invited to participate in the study.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: