Ignite Creation Date:
2024-05-06 @ 8:08 AM
Last Modification Date:
2024-10-26 @ 11:56 AM
Study NCT ID:
NCT02670499
Status:
COMPLETED
Last Update Posted:
2017-06-27
First Post:
2015-09-04
Brief Title:
Study Comparing GAP-Flex to CPM Therapy in Treatment of TKR
Sponsor:
Xeras Medical Technologies
Organization:
Xeras Medical Technologies
Study Overview
Official Title:
A Randomized Controlled Multicenter Study Comparing GAP-FLEX to Continuous Passive Motion CPM Therapy in Combination With Standard of Care Physical Therapy in Subjects With Total Knee Replacement TKR
Status:
COMPLETED
Status Verified Date:
2017-06
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:
GAP-Flex
Brief Summary:
Post Market TKR study
Detailed Description:
A post-market study to evaluate the safety and effectiveness of the GAP-FLEX device in combination with standard of care physical therapy compared to the standard of care CPM device in combination with standard of care physical therapy in Subjects who have undergone TKR
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