Ignite Creation Date:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2025-12-25 @ 8:17 PM
Study NCT ID:
NCT02058069
Status:
COMPLETED
Last Update Posted:
2017-04-18
First Post:
2014-02-03
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Robotic Arm Assisted Total Knee Arthroplasty
Sponsor:
MAKO Surgical Corp.
Organization:
Study Overview
Official Title:
Robotic Arm Assisted Total Knee Arthroplasty
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:
The Investigation will be conducted as a single-submission, multi-center study with approval from and in compliance of the Western Institutional Review Board (WIRB).
The overall objective of this Investigation is to assess the safety and effectiveness of the Robotic Arm Interactive Orthopedic System (RIO) Total Knee Arthroplasty Application. Specifically, the study objectives are classified as follows:
* Primary Objective: Surgeon assessment of standardized TKA complications both intra-operatively and at short term follow up.
* Secondary Objective: Radiographic assessment of post-operative limb alignment.
* Supporting Objective: Patient assessment of post-operative function and satisfaction.
The overall objective of this Investigation is to assess the safety and effectiveness of the Robotic Arm Interactive Orthopedic System (RIO) Total Knee Arthroplasty Application. Specifically, the study objectives are classified as follows:
* Primary Objective: Surgeon assessment of standardized TKA complications both intra-operatively and at short term follow up.
* Secondary Objective: Radiographic assessment of post-operative limb alignment.
* Supporting Objective: Patient assessment of post-operative function and satisfaction.
Detailed Description:
None
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 20131148 | OTHER | WIRB Protocol | View |