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

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

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01912924

Enrollment

Registered

2013-07-31

Start date

2011-08-31

Completion date

2013-05-31

Last updated

2013-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pain

Keywords

chronic pain from failed knee surgery

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.

Interventions

DEVICESpinal cord stimulator (Boston Scientific)

spinal cord stimulator trial leads and hand held battery

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Pain Visual Analog Scale	one year	standardized visual pain scale

Secondary

Measure	Time frame	Description
Health Related Quality of Life	one year	Health Related Quality of Life standardized questionaire

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026