Study of RNS60 on Pain and Function After Knee Anterior Cruciate Ligament Surgery
This study is not yet open for participant recruitment.
Verified December 2013 by Revalesio Corporation
Information provided by (Responsible Party):
First received: August 9, 2013
Last updated: December 3, 2013
Last verified: December 2013
The purpose of this study is to see if use of RNS60 during ACL reconstruction surgery decreases pain and improves functional capacity post-operation.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||Study of RNS60 on Post-operative Pain and Function in Patients Undergoing Knee Anterior Cruciate Reconstruction Surgery|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Revalesio Corporation:
Primary Outcome Measures:
- Assessment of post-operative pain [ Time Frame: 1 week ]
|Study Start Date:||January 2014|
|Estimated Primary Completion Date:||February 2014 (Final data collection date for primary outcome measure)|
RNS60 given intra-articularly as the last 1 liter of irrigation + peripheral i.v. administration.
Placebo Comparator: Saline
Saline given intra-articularly as the last 1 liter of irrigation + peripheral i.v. administration.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01922427
|United States, Colorado|
|Steadman Philippon Research Clinic||Not yet recruiting|
|Vail, Colorado, United States, 81657|
|Contact: Karen Briggs, MPH 970-479-5783|
|Principal Investigator: Robert LaPrade, M.D., PhD|
Sponsors and Collaborators