Ignite Creation Date:
2025-12-18 @ 8:20 AM
Ignite Modification Date:
2025-12-23 @ 9:49 PM
Study NCT ID:
NCT04180423
Status:
None
Last Update Posted:
2023-10-25 00:00:00
First Post:
2019-11-25 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
TKA Operating Room Efficiency for TKA Using Customized Implant Techniques
Sponsor:
None
Organization:
Study Overview
Official Title:
What Factors Affect Operating Room Efficiency When Performing TKA Using Customized Implant Techniques: Conformis iTotal (CR), (PS)
Status:
None
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 is a multi-centered prospective, consecutively enrolled study that will be conducted in the United States. Surgeons that are new users of the iTotal Knee system (defined by no experience using the customized Total Knee Replacement (TKR) in the last 6 months) will be involved in the study. To complete the study protocol, the center will collect baseline surgical and training data on 10 "off-the-shelf" TKR patients using the implant system the surgeon currently uses. Then the first 50 consecutive patients who have been identified to receive the iTotal implant (Cruciate-Retaining or Posterior-Stabilizing) based on patient factors and the implant system IFU will be enrolled in the study. Simultaneous bilateral Total Knee Arthroplasty cases will be excluded.
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?: