Ignite Creation Date:
2024-05-06 @ 7:54 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06173713
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-06
First Post:
2023-12-06
Brief Title:
Emphasys Radiostereometric Analysis
Sponsor:
Canadian Radiostereometric Analysis Network
Organization:
Canadian Radiostereometric Analysis Network
Study Overview
Official Title:
Multi-Center Non-Controlled Prospective Radiostereometric Analysis of Emphasys Hip Solutions
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is designed as a prospective multi-centre non-randomized non-controlled study This study does not limit the procedures involved in the treatment of the subject as long as the protocol specified products are utilized
The primary objective is to establish the mean superior cup migration of the Emphasys Shell and the mean inferior stem migration of the Emphasys Stem using model-based RSA over the first two years post-implantation Additionally the data from this study will be compared to historical Pinnacle Acetabular Shell data obtained in study DSJ_2018_02
The primary objective is to establish the mean superior cup migration of the Emphasys Shell and the mean inferior stem migration of the Emphasys Stem using model-based RSA over the first two years post-implantation Additionally the data from this study will be compared to historical Pinnacle Acetabular Shell data obtained in study DSJ_2018_02
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None