NCT02005523

Brief Summary

The purpose of this study is to see if use of RNS60 during hip labral repair surgery decreases pain and improves functional capacity post-operation.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 3, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 9, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Last Updated

February 6, 2015

Status Verified

February 1, 2015

First QC Date

December 3, 2013

Last Update Submit

February 4, 2015

Conditions

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

Study Arms (2)

RNS60

EXPERIMENTAL
Drug: RNS60

Saline

PLACEBO COMPARATOR
Drug: Saline

Interventions

RNS60DRUG
RNS60
SalineDRUG
Saline

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Tacoma, Washington, United States

Location

MeSH Terms

Interventions

RNS60Sodium Chloride

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds
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

December 3, 2013

First Posted

December 9, 2013

Primary Completion

October 1, 2014

Last Updated

February 6, 2015

Record last verified: 2015-02

Locations