Ignite Creation Date:
2025-12-25 @ 12:56 AM
Ignite Modification Date:
2026-03-01 @ 5:37 PM
Study NCT ID:
NCT02885467
Status:
TERMINATED
Last Update Posted:
2018-05-21
First Post:
2016-08-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nerve Burial for Preventing Neuralgia After Total Knee Arthroplasty
Sponsor:
Medstar Health Research Institute
Organization:
Study Overview
Official Title:
Saphenous Nerve Brach Burial for Preventing Neuralgia After Total Knee Arthroplasty: A Randomized Controlled Trial
Status:
TERMINATED
Status Verified Date:
2018-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Terminated by IRB
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a randomized study investigating whether identification, ligation, and burial of superficial branches of the saphenous nerve crossing the surgical field during total knee arthroplasty reduces the rate of post-operative anterior knee pain and neuralgia compared to standard total knee arthroplasty.
Detailed Description:
Anterior knee pain is common after total knee arthroplasty. The incision necessarily travels through the path of a cutaneous nerve - branches of the saphenous nerve. Historically, no effort has been made to separate these branches and bury them away from the surgical scar. It has been noted that some patients develop a painful neuroma, that once resected results in a pain free knee. Investigators are trying to study if identification, ligation, and proper burial of the nerve can prevent the development of neuralgia compared to the typical surgical approach which ignores the nerve branches completely.
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?: