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

NCT ID: NCT01912924

Last Updated: 2013-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2013-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Chronic Pain

Keywords

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chronic pain from failed knee surgery

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Spinal cord stimulator (Boston Scientific)

spinal cord stimulator trial leads and hand held battery

Intervention Type DEVICE

Other Intervention Names

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Boston Scientific

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boston Scientific Corporation

INDUSTRY

Sponsor Role collaborator

Coastal Orthopedics & Sports Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gennady Gekht, MD

Role: PRINCIPAL_INVESTIGATOR

Coastal Orthopedics & Sports Medicine

Locations

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Coastal Orthopedics & Sports Medicine

Bradenton, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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AGFK001

Identifier Type: -

Identifier Source: org_study_id