Back to resultsA Prospective Trial for the Effectiveness of the Use of Spinal Cord Stimulation (SCS) in Failed Knee Surgery
Primary Purpose
Chronic Pain
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Spinal cord stimulator (Boston Scientific)
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain focused on measuring chronic pain from failed knee surgery
Eligibility Criteria
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
Sites / Locations
- Coastal Orthopedics & Sports Medicine
Outcomes
Primary Outcome Measures
Pain Visual Analog Scale
standardized visual pain scale
Secondary Outcome Measures
Health Related Quality of Life
Health Related Quality of Life standardized questionaire
Full Information
NCT ID
NCT01912924
First Posted
February 3, 2010
Last Updated
July 29, 2013
Sponsor
Coastal Orthopedics & Sports Medicine
Collaborators
Boston Scientific Corporation
1. Study Identification
Unique Protocol Identification Number
NCT01912924
Brief Title
A Prospective Trial for the Effectiveness of the Use of Spinal Cord Stimulation (SCS) in Failed Knee Surgery
Official Title
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"
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Withdrawn
Why Stopped
Difficult enrollment, no subjects identified to enroll
Study Start Date
August 2011 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Coastal Orthopedics & Sports Medicine
Collaborators
Boston Scientific Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
chronic pain from failed knee surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Spinal cord stimulator (Boston Scientific)
Other Intervention Name(s)
Boston Scientific
Intervention Description
spinal cord stimulator trial leads and hand held battery
Primary Outcome Measure Information:
Title
Pain Visual Analog Scale
Description
standardized visual pain scale
Time Frame
one year
Secondary Outcome Measure Information:
Title
Health Related Quality of Life
Description
Health Related Quality of Life standardized questionaire
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gennady Gekht, MD
Organizational Affiliation
Coastal Orthopedics & Sports Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Coastal Orthopedics & Sports Medicine
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34209
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Prospective Trial for the Effectiveness of the Use of Spinal Cord Stimulation (SCS) in Failed Knee Surgery
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