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"
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Locations
- 2
- Primary Endpoint
- Pain Visual Analog Scale
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Pain Visual Analog Scale
Time Frame: one year
standardized visual pain scale
Secondary Outcomes
- Health Related Quality of Life(one year)