Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2025-12-29 @ 11:08 PM
Study NCT ID:
NCT01820650
Status:
TERMINATED
Last Update Posted:
2023-10-25
First Post:
2013-03-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Prospective, Multicenter Study to Evaluate the ConforMIS iTotal® (CR) Knee Replacement System
Sponsor:
Restor3D
Organization:
Study Overview
Official Title:
A Prospective, Multicenter Study to Evaluate the ConforMIS iTotal® (CR) Knee Replacement System
Status:
TERMINATED
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Decision of investigational team
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 to observe the long term clinical outcomes of patient-specific knee arthroplasty in patients with osteoarthritis.
Detailed Description:
If the patient has previously received a standard total knee replacement in their contralateral knee, the primary endpoint questionnaire and some secondary endpoint questionnaires will be completed regarding BOTH their iTotal® CR knee and their standard total knee for all time points where questionnaires are required by the protocol.
Study Oversight
Has Oversight DMC:
False
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?: