Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2025-12-27 @ 11:05 PM
Study NCT ID:
NCT00733694
Status:
COMPLETED
Last Update Posted:
2025-02-28
First Post:
2008-08-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Outcome Study of Total Knee Arthroplasty in Asian Patients
Sponsor:
DePuy International
Organization:
Study Overview
Official Title:
Clinical Evaluation of the Low Contact Stress (LCS) Classic and Universal Mobile-bearing Total Knee System. The Asian LCS User Group - 'The Dragon Knee Study'
Status:
COMPLETED
Status Verified Date:
2025-02
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:
DRAGON
Brief Summary:
To determine how the LCS mobile bearing knee system works within the Asian Population.
Detailed Description:
The objective of this clinical evaluation is to compile a profile of the performance of the LCS Mobile bearing total knee system in normal clinical practice within the Asian Population. Performance will be assessed using specific surgeon and patient based outcome scores.
Total subject enrolled 505; 6 subjects did not receive device. Total subjects received device 499.
Among those who received devices, 391 subjects unilateral and 108 bilateral, therefore, total 607 knees in the study
Total subject enrolled 505; 6 subjects did not receive device. Total subjects received device 499.
Among those who received devices, 391 subjects unilateral and 108 bilateral, therefore, total 607 knees in the study
Study Oversight
Has Oversight DMC:
False
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?: