NCT01922427

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.

Trial Health

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 9, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 14, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Last Updated

April 10, 2015

Status Verified

January 1, 2015

First QC Date

August 9, 2013

Last Update Submit

April 8, 2015

Conditions

Anterior Cruciate Ligament Reconstruction

Outcome Measures

Primary Outcomes (1)

  • Assessment of Post-operative pain

    Comparison of scores from validated pain scales from post-surgery to one week

    1 week

Interventions

RNS60DRUG

Sponsors & Collaborators

MeSH Terms

Interventions

RNS60
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2013

First Posted

August 14, 2013

Primary Completion

October 1, 2014

Last Updated

April 10, 2015

Record last verified: 2015-01