Status:
WITHDRAWN
A Prospective Trial for the Effectiveness of the Use of Spinal Cord Stimulation (SCS) in Failed Knee Surgery
Lead Sponsor:
Coastal Orthopedics & Sports Medicine
Collaborating Sponsors:
Boston Scientific Corporation
Conditions:
Chronic Pain
Eligibility:
All Genders
18+ years
Phase:
NA
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 admini...
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 recei...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01912924
Start Date
August 1 2011
End Date
May 1 2013
Last Update
July 31 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Coastal Orthopedics & Sports Medicine
Bradenton, Florida, United States, 34209