RadiculopathyNCT02350621
Cervical Foraminal Stenosis and Radiculopathy - ACDF Versus Minimal Invasive Posterior Cervical Foraminotomy.
A study testing ACDF and minimal invasive Posterior Cervical Foraminotomy in people with Radiculopathy, run by Stockholm Spine Center AB.
Trial summary
A prospective randomized clinical trial. Cervical spondylotic foraminal stenosis with radiculopahty. Comparison results between 2 treatment options: ACDF and minimal invasive posterior cervical foraminiotomy. 80 patients to be followed for 2 years. Read more about this study
- Who is it for?
- Ages 25 to 70 years
- Conditions the study is for
- Radiculopathy
- What is being tested?
- ACDF and minimal invasive Posterior Cervical Foraminotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Feb 2015to Feb 2018
- 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 25 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cervical radiculopathy on 1 or 2 levels correlated on MRI and CT Arm pain more than 30 (VAS). Duration more than 3 months.
Who cannot join
- Myelopathy. Soft disc hernia. Previous neck surgery. Tumors, infection, WAD, trauma, generalized pain syndrome.
Trial locations and contacts
No sites are listed yet.
Andreas Selander, MD contact
Anton Rasch, MD, PhD contact
About this study
Official title: Cervical Foraminal Stenosis and Radiculopathy - Anterior Cervical Discectomy and Fusion (ACDF) Versus Minimal Invasive Posterior Cervical Foraminotomy miPCF).
A prospective randomized clinical trial. Cervical spondylotic foraminal stenosis with radiculopahty. Comparison results between 2 treatment options: ACDF and minimal invasive posterior cervical foraminiotomy.
80 patients to be followed for 2 years. Parameters to study: NDI, VAS, EQ-5D, complications, health economics, recurrens of stenosis, movement of facet joints pre- and postoperatively (foraminotomy group).
- Conditions
- Radiculopathy
- Being tested
- ACDF, minimal invasive Posterior Cervical Foraminotomy
- Keywords
- cervical foraminal stenosis minimal invasive foraminotomy
- Medical subject headings
- Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACDFProcedure or surgery
minimal invasive Posterior Cervical ForaminotomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| ACDF | Active comparator | Anterior Cervical Discectomy and Fusion Receives: Procedure: ACDF |
| miPCF | Active comparator | minimal invasive Posterior Cervical Foraminotomy Receives: Procedure: minimal invasive Posterior Cervical Foraminotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neck Disability Index
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2015 (estimated)
- Study startFeb 2015
- Primary completionFeb 2017 (estimated)
- Study completionFeb 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RadiculopathyStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stockholm Spine Center AB
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andreas Selander, Stockholm Spine Center AB
- Investigators
- Tycho Tullberg, MD, PhD, Study chair, Stockholm Spine Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02350621
- Sponsor's protocol ID
- 2014/1150-31/2
- Status last verified
- Jan 2015
- First submitted
- 26 Jan 2015
- Last updated
- 29 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cervical Foraminal Stenosis and Radiculopathy - Anterior Cervical Discectomy and Fusion (ACDF) Versus Minimal Invasive Posterior Cervical Foraminotomy miPCF).
- ClinicalTrials.gov ID
- NCT02350621
- Acronym / sponsor ID
- 2014/1150-31/2
- Conditions
- Radiculopathy
- Keywords
- cervical foraminal stenosis minimal invasive foraminotomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Stockholm Spine Center ABUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Feb 2017 (estimated)
- Study completion
- Feb 2018 (estimated)
- First posted
- 29 Jan 2015 (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 prospective randomized clinical trial. Cervical spondylotic foraminal stenosis with radiculopahty. Comparison results between 2 treatment options: ACDF and minimal invasive posterior cervical foraminiotomy.
80 patients to be followed for 2 years. Parameters to study: NDI, VAS, EQ-5D, complications, health economics, recurrens of stenosis, movement of facet joints pre- and postoperatively (foraminotomy group).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACDF | Active comparator | Procedure: ACDFAnterior Cervical Discectomy and Fusion |
| miPCF | Active comparator | Procedure: minimal invasive Posterior Cervical Foraminotomyminimal invasive Posterior Cervical Foraminotomy |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Cervical radiculopathy on 1 or 2 levels correlated on MRI and CT Arm pain more than 30 (VAS). Duration more than 3 months.
Key exclusion criteria (1 listed)
- Myelopathy. Soft disc hernia. Previous neck surgery. Tumors, infection, WAD, trauma, generalized pain syndrome.
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 |
|---|---|---|
| ACDF | Procedure or surgery | ACDF |
| minimal invasive Posterior Cervical Foraminotomy | Procedure or surgery | miPCF |
Primary outcome
Neck Disability Index
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2015.
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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.
Andreas Selander, MD contact
Anton Rasch, MD, PhD contact
Tycho Tullberg, MD, PhD study chair
Stockholm Spine Center
Questions about this trial
What is this clinical trial studying?
A study testing ACDF and minimal invasive Posterior Cervical Foraminotomy in people with Radiculopathy, run by Stockholm Spine Center AB.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 29 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andreas Selander, MD (andreas.selander@spinecenter.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neck Disability Index (time frame: 24 months). 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 29 Jan 2015.