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

Coastal Orthopedics & Sports Medicine

Status: Withdrawn

Conditions: Chronic Pain

Treatments: Device: Spinal cord stimulator (Boston Scientific)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01912924

AGFK001

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)