Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06626490
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-19
Brief Title:
Prospective Follow-up of the Prevision Hip Stem With Comparison of Different Implant Variants
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Prospective Follow-up of the Prevision Hip Stem With Comparison of Different Implant Variants
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PREMO
Brief Summary:
The study design is confirmative for non-inferiority of the functional outcome of the implants and is intended to examine the safety and performance of the Prevision hip stem The study is an observational post-market clinical follow-up study and the study sites chose the stem variant depending on their own routine and indication
Detailed Description:
Generally the advantage of the Prevision implant family is that all implant variants can be implanted with basically the same instrumentation which makes it easier to switch to another variant All implant variants will be available at the study sites and switching between the variants in the study will be encouraged
The aim of the study is to prove the non-inferiority of the OHS functional outcome after two years to the predecessor implant generation and comparable revision hip stems In addition the patient groups treated with the different variants and outcome of these subgroups will be descriptively compared
The aim of the study is to prove the non-inferiority of the OHS functional outcome after two years to the predecessor implant generation and comparable revision hip stems In addition the patient groups treated with the different variants and outcome of these subgroups will be descriptively compared
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None