Ignite Creation Date:
2025-12-24 @ 9:54 PM
Ignite Modification Date:
2025-12-28 @ 4:41 PM
Study NCT ID:
NCT07115732
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-29
First Post:
2025-08-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ACE Acetabular Cup Spanish PMCF Study
Sponsor:
JRI Orthopaedics
Organization:
Study Overview
Official Title:
A Prospective Single Centre Post Market Clinical Follow-up Study of the JRI Orthopaedic ACE Acetabular Cup System in Spain
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-08
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, involving the replacement of both the hip ball and socket. Its goal is to provide pain relief and enable the patient to return to a normal lifestyle. JRI Orthopaedics have developed the ACE Acetabular Cup System, which has an H-A.C. coating to promote osseointegration of the device within the host bone. To increase the surgeon's choice and thus suitability for the patient, there is the option of three 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 device's 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 will be done by examining patient outcomes through questionnaires, reviews of X-rays, and recording any complications in 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 device's 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 will be done by examining patient outcomes through questionnaires, reviews of X-rays, and recording any complications in 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:
False
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?:
False
Is an FDA AA801 Violation?: