Ignite Creation Date:
2024-05-06 @ 1:46 PM
Last Modification Date:
2024-10-26 @ 1:20 PM
Study NCT ID:
NCT04123431
Status:
NOT_YET_RECRUITING
Last Update Posted:
2020-07-28
First Post:
2019-10-09
Brief Title:
ACE Acetabular Cup UK Multi-centre PMCF Study
Sponsor:
JRI Orthopaedics
Organization:
JRI Orthopaedics
Study Overview
Official Title:
A Prospective UK Multi-Centre Post Market Clinical Follow-up Study of the JRI Orthopaedic ACE Acetabular Cup System
Status:
NOT_YET_RECRUITING
Status Verified Date:
2019-10
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:
A total hip replacement is one of the most successful and cost-effective surgical procedures in orthopaedics and involves replacing both the hip ball and socket Its goal is to provide pain relief allowing the person to return to a normal lifestyle JRI Orthopaedics have developed the ACE Acetabular Cup System which has a H-AC coating to promote ossoeintegration of the device within the host bone To increase the surgeons choice and thus suitability for the patient there is the option of 3 different socket liners ceramic polymer or dual mobility
To ensure maximum safety and performance of medical devices surveillance of the device should be carried out over the devices lifetime This study is a 10 year surveillance study to assess the clinical functional and radiological outcomes of the CE-marked ACE Acetabular Cup System This is done by examining patient outcomes through questionnaires reviews of X-rays and complications by patients who have received a total hip replacement using the ACE Acetabular Cup System at participating sites
To ensure maximum safety and performance of medical devices surveillance of the device should be carried out over the devices lifetime This study is a 10 year surveillance study to assess the clinical functional and radiological outcomes of the CE-marked ACE Acetabular Cup System This is done by examining patient outcomes through questionnaires reviews of X-rays and complications by patients who have received a total hip replacement using the ACE Acetabular Cup System at participating sites
Detailed Description:
None
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?:
None