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

Anterior Cruciate Ligament Reconstruction Clinical Trial

Official title:

Study of RNS60 on Post-operative Pain and Function in Patients Undergoing Knee Anterior Cruciate Reconstruction Surgery

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01922427
• Other study ID #: 07.1.1.H1
• Status: Withdrawn
• Phase: Phase 2
• First received: August 9, 2013
• Last updated: April 8, 2015

Study information

• Verified date: January 2015
• Source: Revalesio Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Reconstruction

Intervention

Drug:
• RNS60

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Revalesio Corporation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of Post-operative pain	Comparison of scores from validated pain scales from post-surgery to one week	1 week	No