Intervertebral Disc DegenerationNCT04408846

Minimally Invasive Surgery Versus Traditional Open Surgery In The Treatment Of Single Level Lumbar Stenosis

A study testing Lumbar fusion in people with Intervertebral Disc Degeneration and Lumbar Spinal Stenosis, run by Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan at 1 site in Russia.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial summary

The purpose of this study is to determine the effectiveness of minimally invasive surgical technique over the traditional open surgical procedure in patients with degenerative lumbar stenosis Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Intervertebral Disc Degeneration, Lumbar Spinal Stenosis
What is being tested?: Lumbar fusion
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: 1 siteRussia
Study dates: 1 Dec 2020to 1 Dec 2023
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 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age 18 to 75 years;
Patient has single level degenerative lumbar spinal stenosis and an indication for a single level instrumented lumbar fusion for the treatment;
Symptoms persisting for at least three months prior to surgery;
Given written Informed Consent;
Able and agree to fully comply with the clinical protocol and willing to adhere to follow-up schedule and requirements.

Who cannot join

Prior lumbar spinal fusion at any level;
Other non-degenerative spinal conditions (e.g. infectious, traumatic, metabolic, inflammatory, neoplastic, structural or other pathology) that may have an impact on subject safety, wellbeing or the intent and conduct of the study;
Any condition that cannot be treated with mini-invasive unilateral decompression and fusion;
History or presence of any other major neurological disease or condition that may interfere with the study assessments (e.g. significant peripheral neuropathy, multiply sclerosis);
Previous enrollment in this study, current enrollment or plans to be enrolled in another study (in parallel to this study).

Trial locations and contacts

1 site in 1 country.

Russia1 site

Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan
Novosibirsk, 630091

Other trials in Russia

About this study

Official title: An Open-Label Randomized Controlled Study of the Efficacy of Surgical Treatment in Patients With Single Level Lumbar Spinal Stenosis Using Minimally Invasive Surgery and Traditional Open Surgical Procedure

The purpose of this study is to determine the effectiveness of minimally invasive surgical technique over the traditional open surgical procedure in patients with degenerative lumbar stenosis

Conditions: Intervertebral Disc Degeneration, Lumbar Spinal Stenosis
Being tested: Lumbar fusion
Medical subject headings: Intervertebral Disc Degeneration, Spinal Stenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Lumbar fusionDevice
Patients will receive a single level instrumented fusion using a minimally invasive or open traditional surgical procedure with a posterior fixation. For the use of a posterior fixation system, the CD Horizon® Spinal System, is mandatory in this study and will be either minimally invasive or open.

Study groups in NCT04408846
Study group	Role	What they receive
Minimally invasive lumbar fusion	Other	Not described Receives: Device: Lumbar fusion
Open posterior lumbar fusion	Other	Not described Receives: Device: Lumbar fusion

What is being measured

The primary outcome is the main question the study is designed to answer.

Change from baseline in Oswestry Disability Index (ODI)
To observe the change of ODI as compared to baseline through follow-up terms
Measured: 3 months

Secondary outcomes (9)

Change from baseline in Oswestry Disability Index (ODI)
To observe the change of ODI as compared to baseline through follow-up terms
Measured: Through 2 years
Change from baseline in Numeric Pain Rating Score (NPRS)
To observe the change of NPRS as compared to baseline through follow-up terms
Measured: Through 2 years
Change from baseline in EuroQol Five-Dimensional descriptive system questionnaire (EQ-5D)
To observe the change of EQ-5D as compared to baseline through follow-up terms
Measured: Through 2 years
Change from baseline in Douleur Neuropathique 4 (DN4)
To observe the change of DN4 as compared to baseline through follow-up terms
Measured: Through 2 years
Change from baseline in The Health Transition Item from SF-36 (HTI Item)
To observe the change of HTI Item through follow-up terms
Measured: Through 2 years
Change from baseline in Clinical Global Impression Of Change (CGIC) scale
To observe the change of CGIC through follow-up terms
Measured: Through 2 years
Fusion rate success
Interbody fusion rate on CT based on Tan grades
Measured: 12 months and 24 months post op
Cost-effectiveness
Total cost of surgical procedure (implanted system, the salary for surgery team) and the cost of patient's staying at the clinic before discharge.
Measured: 14th day of hospital stay
Adverse Events
Document Adverse Events (incl. adverse events related to device) occurrence throughout the study
Measured: Through 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Dec 20201 Dec 2023

First posted29 May 2020
Study start1 Dec 2020 (estimated)
Primary completion1 Dec 2021 (estimated)
Study completion1 Dec 2023 (estimated)

Why it stopped: The Study will be conducted in another research center. The Sponsor has changed.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Intervertebral Disc DegenerationStudies 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: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04408846
Sponsor's protocol ID: NS02-01
Status last verified: May 2020
First submitted: 20 May 2020
Last updated: 11 Sep 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Relationship Between Disability, Flexibility, Back Muscles, and Thoracolumbar Fascia in Patients With Lumbar Disc Degeneration
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Active, not recruiting
ASCEND: A Clinical Trial to Evaluate the Safety and Effectiveness of VIA Disc NP, a Supplement for Degenerated Intervertebral Discs
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Active, not recruiting
The Synergy Disc for the Treatment of 2 Level Cervical Degenerative Disc Disease Compared With Cervical Fusion Surgery
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All Intervertebral Disc Degeneration trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label Randomized Controlled Study of the Efficacy of Surgical Treatment in Patients With Single Level Lumbar Spinal Stenosis Using Minimally Invasive Surgery and Traditional Open Surgical Procedure
ClinicalTrials.gov ID: NCT04408846
Acronym / sponsor ID: NS02-01
Conditions: Intervertebral Disc Degeneration, Lumbar Spinal Stenosis
Study type: Interventional
Recruitment status: WithdrawnReason stopped: The Study will be conducted in another research center. The Sponsor has changed.
Enrolment: 0 participants (actual)
Lead sponsor: Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. TsivyanOther government
Collaborators: Medtronic
Study start: 1 Dec 2020 (estimated)
Primary completion: 1 Dec 2021 (estimated)
Study completion: 1 Dec 2023 (estimated)
First posted: 29 May 2020 (actual)
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.

The purpose of this study is to determine the effectiveness of minimally invasive surgical technique over the traditional open surgical procedure in patients with degenerative lumbar stenosis

Study design

Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Minimally invasive lumbar fusion	Other	Device: Lumbar fusion
Open posterior lumbar fusion	Other	Device: Lumbar fusion

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Age 18 to 75 years;
Patient has single level degenerative lumbar spinal stenosis and an indication for a single level instrumented lumbar fusion for the treatment;
Symptoms persisting for at least three months prior to surgery;
Given written Informed Consent;
Able and agree to fully comply with the clinical protocol and willing to adhere to follow-up schedule and requirements.

Key exclusion criteria (5 listed)

Prior lumbar spinal fusion at any level;
Other non-degenerative spinal conditions (e.g. infectious, traumatic, metabolic, inflammatory, neoplastic, structural or other pathology) that may have an impact on subject safety, wellbeing or the intent and conduct of the study;
Any condition that cannot be treated with mini-invasive unilateral decompression and fusion;
History or presence of any other major neurological disease or condition that may interfere with the study assessments (e.g. significant peripheral neuropathy, multiply sclerosis);
Previous enrollment in this study, current enrollment or plans to be enrolled in another study (in parallel to this study).

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
Lumbar fusionPatients will receive a single level instrumented fusion using a minimally invasive or open traditional surgical procedure with a posterior fixation. For the use of a posterior fixation system, the CD Horizon® Spinal System, is mandatory in this study and will be either minimally invasive or open.	Device	Minimally invasive lumbar fusion, Open posterior lumbar fusion

Primary outcome

Change from baseline in Oswestry Disability Index (ODI)
Time frame: 3 months
To observe the change of ODI as compared to baseline through follow-up terms

9 secondary outcomes

Change from baseline in Oswestry Disability Index (ODI)
Time frame: Through 2 years
Change from baseline in Numeric Pain Rating Score (NPRS)
Time frame: Through 2 years
Change from baseline in EuroQol Five-Dimensional descriptive system questionnaire (EQ-5D)
Time frame: Through 2 years
Change from baseline in Douleur Neuropathique 4 (DN4)
Time frame: Through 2 years
Change from baseline in The Health Transition Item from SF-36 (HTI Item)
Time frame: Through 2 years
Change from baseline in Clinical Global Impression Of Change (CGIC) scale
Time frame: Through 2 years
Fusion rate success
Time frame: 12 months and 24 months post op
Cost-effectiveness
Time frame: 14th day of hospital stay
Adverse Events
Time frame: Through 2 years

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 11 Sep 2020.

Related trials for Intervertebral Disc Degeneration

Not yet recruiting
CANLINK: Evaluation of the Intralink Intradiscal Device for Low Back Pain Due to Degenerative Disc Disease
Degenerative Disc Disease(DDD)
Active, not recruiting
Post Marketing Study of MagnetOs Easypack Putty Standalone Compared to Demineralized Bone Matrix or Fibers Mixed With Autograft in Patients Undergoing Posterolateral Lumbar Fusion
Degenerative Disc Disease, Spine Fusion
Not yet recruitingObservational study
Relationship Between Disability, Flexibility, Back Muscles, and Thoracolumbar Fascia in Patients With Lumbar Disc Degeneration
Intervertebral Disc Degeneration
Active, not recruiting
ASCEND: A Clinical Trial to Evaluate the Safety and Effectiveness of VIA Disc NP, a Supplement for Degenerated Intervertebral Discs
Degenerative Disc Disease, Disc Degeneration
Active, not recruiting
The Synergy Disc for the Treatment of 2 Level Cervical Degenerative Disc Disease Compared With Cervical Fusion Surgery
Cervical Degenerative Disc Disease

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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 inclusion and 5 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 11 Sep 2020. 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 Russia. 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?

Change from baseline in Oswestry Disability Index (ODI) (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04408846.

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 11 Sep 2020.