NCT01912924

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2011

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 3, 2010

Completed
1.5 years until next milestone

Study Start

First participant enrolled

August 1, 2011

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 31, 2013

Completed
Last Updated

July 31, 2013

Status Verified

July 1, 2013

Enrollment Period

1.8 years

First QC Date

February 3, 2010

Last Update Submit

July 29, 2013

Conditions

Chronic Pain

Keywords

chronic pain from failed knee surgery

Outcome Measures

Primary Outcomes (1)

  • Pain Visual Analog Scale

    standardized visual pain scale

    one year

Secondary Outcomes (1)

  • Health Related Quality of Life

    one year

Interventions

Spinal cord stimulator (Boston Scientific)DEVICE

spinal cord stimulator trial leads and hand held battery

Also known as: Boston Scientific

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 -

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Coastal Orthopedics & Sports Medicine

Bradenton, Florida, 34209, United States

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Gennady Gekht, MD

    Coastal Orthopedics & Sports Medicine

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2010

First Posted

July 31, 2013

Study Start

August 1, 2011

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

July 31, 2013

Record last verified: 2013-07

Locations

US(1)