A Prospective Trial for the Effectiveness of the Use of Spinal Cord Stimulation (SCS) in Failed Knee Surgery

July 29, 2013 updated by: Coastal Orthopedics & Sports Medicine

A Prospective Single Centre Open Label Trial to Assess the Effectiveness of the Use of Spinal Cord Stimulation in Subjects With Chronic Knee Pain "Failed Knee Surgery"

A study for patients who have chronic postoperative pain who had knee replacement surgery. If qualified, a 14 day trial and an implantation of spinal cord stimulator for control of pain will be administered. This study will evaluate effectiveness of pain control. Subjects will be followed for one year post implantation.

Study Overview

Status

Withdrawn

Conditions

Chronic Pain

Intervention / Treatment

Device: Spinal cord stimulator (Boston Scientific)

Detailed Description

Male and Female over the age of 18 who have had a total knee replacement at least nine months ago. Continue with unilateral knee pain equal to or greater than 4 on a 1 to 10 scale. Subjects will receive a trial placement of spinal cord stimulator for 5 to 10 days. if trial is successful subjects will proceed to permanent placement of stimulator for the treatment of the knee pain. subjects will then be followed post implant to assess the effectiveness of the stimulator for the pain.

Study Type

Interventional

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Florida
  - Bradenton, Florida, United States, 34209
    - Coastal Orthopedics & Sports Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

over 18 years old
total knee replacement at least nine months prior to enrollment
unilateral knee pain at least 4 or more on a 1-10 visual analog scale
failed other conservative treatments -

Exclusion Criteria:

life expectancy of at least 6 months
significant disease including Complex Regional Pain Syndrome,ipsilateral radiculopathy
presence of pacemaker/vns or other Spinal Cord Stimulator
previous lumbar surgery
active infection
unable to hold anticoagulants

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Visual Analog Scale Time Frame: one year	standardized visual pain scale	one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health Related Quality of Life Time Frame: one year	Health Related Quality of Life standardized questionaire	one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Coastal Orthopedics & Sports Medicine

Collaborators

Boston Scientific Corporation

Investigators

Principal Investigator: Gennady Gekht, MD, Coastal Orthopedics & Sports Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)