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

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.
ClinicalTrials.gov Identifier: NCT01922427
Recruitment Status : Withdrawn
First Posted : August 14, 2013
Last Update Posted : April 10, 2015
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Anterior Cruciate Ligament Reconstruction Drug: RNS60 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
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
Primary Completion Date : October 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Outcome Measures

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Accepts Healthy Volunteers:   No
More Information

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