NCT02739230

Brief Summary

The goal of this research project is to evaluate the effectiveness of a novel treatment to control pain after Total Knee Arthroplasty (TKA). The proposed approach to manage pain and eliminate risks associated with catheters is the use of Exparel injection into the joint at the time of surgery.

Trial Health

100
On Track

Trial Health Score

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

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 7, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 15, 2016

Completed
Last Updated

April 15, 2016

Status Verified

April 1, 2016

Enrollment Period

1.8 years

First QC Date

April 7, 2016

Last Update Submit

April 14, 2016

Conditions

Osteoarthritis: Joint Replacement Surgery

Outcome Measures

Primary Outcomes (1)

  • Total Morphine and morphine equivalent consumption

    96 hours post-op

Study Arms (2)

Exparel Injection

ACTIVE COMPARATOR
Drug: Exparel

On-Q intraarthicual catheter placement

ACTIVE COMPARATOR
Drug: On-Q pain intra-articular catheter

Interventions

ExparelDRUG
Exparel Injection
On-Q pain intra-articular catheterDRUG
On-Q intraarthicual catheter placement

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults scheduled to undergo primary total knee replacement
  • Willing and able to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2016

First Posted

April 15, 2016

Study Start

December 1, 2013

Primary Completion

October 1, 2015

Last Updated

April 15, 2016

Record last verified: 2016-04