Chronic PainNCT01912924
A Prospective Trial for the Effectiveness of the Use of Spinal Cord Stimulation (SCS) in Failed Knee Surgery
A study testing Spinal cord stimulator (Boston Scientific) in people with Chronic Pain, run by Coastal Orthopedics & Sports Medicine at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Spinal cord stimulator (Boston Scientific)
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to May 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 -
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Coastal Orthopedics & Sports Medicine
Bradenton, Florida, 34209
About this study
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"
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.
Read the 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.
- Conditions
- Chronic Pain
- Being tested
- Spinal cord stimulator (Boston Scientific)
- Keywords
- chronic pain from failed knee surgery
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal cord stimulator (Boston Scientific)Device
Also called Boston Scientific
spinal cord stimulator trial leads and hand held battery
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Visual Analog Scale
standardized visual pain scale
Measured: one year
Secondary outcomes (1)
Health Related Quality of Life
Health Related Quality of Life standardized questionaire
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2013 (estimated)
- Study startAug 2011
- Primary completionMay 2013
- Study completionMay 2013
Why it stopped: Difficult enrollment, no subjects identified to enroll
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coastal Orthopedics & Sports Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation
- Responsible party
- Sponsor
- Investigators
- Gennady Gekht, MD, Principal investigator, Coastal Orthopedics & Sports Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01912924
- Sponsor's protocol ID
- AGFK001
- Status last verified
- Jul 2013
- First submitted
- 3 Feb 2010
- Last updated
- 31 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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"
- ClinicalTrials.gov ID
- NCT01912924
- Acronym / sponsor ID
- AGFK001
- Conditions
- Chronic Pain
- Keywords
- chronic pain from failed knee surgery
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Difficult enrollment, no subjects identified to enroll
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Coastal Orthopedics & Sports MedicineUniversity, hospital or other
- Collaborators
- Boston Scientific Corporation
- Study start
- Aug 2011
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 31 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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 -
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spinal cord stimulator (Boston Scientific)Also: Boston Scientificspinal cord stimulator trial leads and hand held battery | Device | – |
Primary outcome
Pain Visual Analog Scale
Time frame: one year
standardized visual pain scale
1 secondary outcome
Health Related Quality of Life
Time frame: one year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gennady Gekht, MD principal investigator
Coastal Orthopedics & Sports Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal cord stimulator (Boston Scientific) in people with Chronic Pain, run by Coastal Orthopedics & Sports Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 31 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Visual Analog Scale (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2013.