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Study of RNS60 on Pain and Function After Knee Anterior Cruciate Ligament Surgery

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01922427
First Posted: August 14, 2013
Last Update Posted: April 10, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Revalesio Corporation
  Purpose
The purpose of this study is to see if use of RNS60 during ACL reconstruction surgery decreases pain and improves functional capacity post-operation.

Condition Intervention Phase
Anterior Cruciate Ligament Reconstruction Drug: RNS60 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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:


Further study details as provided by Revalesio Corporation:

Primary Outcome Measures:
  • Assessment of Post-operative pain [ Time Frame: 1 week ]
    Comparison of scores from validated pain scales from post-surgery to one week


Enrollment: 0
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Accepts Healthy Volunteers:   No
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Revalesio Corporation
ClinicalTrials.gov Identifier: NCT01922427     History of Changes
Other Study ID Numbers: 07.1.1.H1
First Submitted: August 9, 2013
First Posted: August 14, 2013
Last Update Posted: April 10, 2015
Last Verified: January 2015