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

This study has been withdrawn prior to enrollment.
Information provided by (Responsible Party):
Revalesio Corporation Identifier:
First received: August 9, 2013
Last updated: April 8, 2015
Last verified: January 2015
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: 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:

Further study details as provided by Revalesio Corporation:

Primary Outcome Measures:
  • Assessment of Post-operative pain [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    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)

Accepts Healthy Volunteers:   No
  Contacts and Locations
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No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Revalesio Corporation Identifier: NCT01922427     History of Changes
Other Study ID Numbers: 07.1.1.H1
Study First Received: August 9, 2013
Last Updated: April 8, 2015
Health Authority: United States: Food and Drug Administration processed this record on November 27, 2015