Ignite Creation Date:
2024-05-05 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00249054
Status:
COMPLETED
Last Update Posted:
2017-03-24
First Post:
2005-11-03
Brief Title:
Prospective Clinical Evaluation of ASR and ReCap Resurfacing Arthroplasty
Sponsor:
Frederiksberg University Hospital
Organization:
Frederiksberg University Hospital
Study Overview
Official Title:
Clinical Performance of the ASR and ReCap Resurfacing Implants-7Years Follow-Up
Status:
COMPLETED
Status Verified Date:
2017-03
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 evaluation is being conducted to evaluate the performance of the ASR arthroplasty The performance of the devices will be assessed by
Clinical parameters pain function satisfaction and complications Blood samples Analyse of metal ions lymphocyte migration lymphocyte proliferation assay and cytokines
Biopsies Metal ions cytokines and histology Biomechanics Strength gait analysis range of motion Scanning DEXA and MRI
Clinical parameters pain function satisfaction and complications Blood samples Analyse of metal ions lymphocyte migration lymphocyte proliferation assay and cytokines
Biopsies Metal ions cytokines and histology Biomechanics Strength gait analysis range of motion Scanning DEXA and MRI
Detailed Description:
None
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