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

Chronic Pain Clinical Trial

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"

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01912924
• Other study ID #: AGFK001
• Status: Withdrawn
• Phase: N/A
• First received: February 3, 2010
• Last updated: July 29, 2013
• Start date: August 2011
• Est. completion date: May 2013

Study information

• Verified date: July 2013
• Source: Coastal Orthopedics & Sports Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Device:
• Spinal cord stimulator (Boston Scientific)
spinal cord stimulator trial leads and hand held battery

Locations

Country	Name	City	State
United States	Coastal Orthopedics & Sports Medicine	Bradenton	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Coastal Orthopedics & Sports Medicine	Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Visual Analog Scale	standardized visual pain scale	one year	No
Secondary	Health Related Quality of Life	Health Related Quality of Life standardized questionaire	one year	No