Fusion of SpineNCT04415814
Unilateral Versus Bilateral Pedicle Screw Fixation for Lumbar Degenerative Diseases
A study testing Unilateral Pedicle Screw Fixation and Bilateral Pedicle Screw Fixation in people with Fusion of Spine, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
Trial summary
Determining the treatment strategy for patients with degenerative diseases of the spine is extremely difficult, without an accurate understanding of the nature of stress distribution in the vertebral-motor segments of the spine, as well as biomechanical changes that are associated with degenerative diseases of the… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Fusion of Spine
- What is being tested?
- Unilateral Pedicle Screw Fixation and Bilateral Pedicle Screw Fixation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteRussia
- Study dates
- 1 Jan 2019to 31 Aug 2022
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent of the patient to participate in the study;
- Patients with degenerative diseases of the lumbar spine.
- The opportunity for observation during the entire study period (12 months);
- Mental adequacy, ability, willingness to cooperate and follow the doctor's recommendations.
Who cannot join
- The refusal of a patient from surgery
- The presence of contraindications to surgery
- Severe forms of diabetes (glycosylated hemoglobin >9%);
- Blood diseases (thrombopenia, thrombocytopenia, anemia with Hb< 90g\l);
- The unwillingness of the patient to conscious cooperation.
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
Sechenov University
Moscow, 119991
Vadim Cherepanov, professor, +79166548850, cvg_cherepanov@mail.ru
Ivan Vyazankin, +79163770457, vzvzvzvan@mail.ru
About this study
Determining the treatment strategy for patients with degenerative diseases of the spine is extremely difficult, without an accurate understanding of the nature of stress distribution in the vertebral-motor segments of the spine, as well as biomechanical changes that are associated with degenerative diseases of the spine. In this clinical study, we want to compare the use of unilateral and bilateral transpedicular fixation for treating the patients with degenerative diseases of the lumbar spine.
Read the detailed description
It is planned to use posterior stabilization without interbody fusion. In the postoperative period, all the patients receive antibacterial and analgesic therapy. The early postoperative period is spent in a hospital. Repeated appearances for control examinations (3, 6, 12 months) are provided for physical examination (EQ-5D, Oswestry Disability Index) and performing radiographs or computed tomography (CT) of the spine. All patients undergo a standard rehabilitation course.
- Conditions
- Fusion of Spine
- Being tested
- Unilateral Pedicle Screw Fixation, Bilateral Pedicle Screw Fixation
- Keywords
- degenerative spine, unilateral fixation of the spine, fusion of the lumbar spine, posterior stabilization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unilateral Pedicle Screw FixationProcedure or surgery
Pedicle screws are installed unilaterally on the one side of the vertebrae and fixed with rod
Bilateral Pedicle Screw FixationProcedure or surgery
Pedicle screws are installed bilaterally on the both sides of the vertebrae and fixed with rods
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (Unilateral Pedicle Screw Fixation) | Experimental | Patients will undergo stabilizing surgery on the lumbar spine for degenerative diseases of the spine. Pedicular screws will be installed unilaterally, which means on one side of the spinous processes. The system will be fixed with standard rod and blockers. Receives: Procedure: Unilateral Pedicle Screw Fixation |
| Group 2 (Bilateral Pedicle Screw Fixation) | Active comparator | Patients will undergo stabilizing surgery on the lumbar spine for degenerative diseases of the spine. Pedicular screws will be installed bilaterally, which means on the both sides of the spinous processes. The system will be fixed with standard rods and blockers. Receives: Procedure: Bilateral Pedicle Screw Fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
fusion rate of the operated spine segment
Control CT/Radiography examination
Measured: in 3 months after surgery
fusion rate of the operated spine segment
Control CT/Radiography examination
Measured: in 6 months after surgery
fusion rate of the operated spine segment
Control CT/Radiography examination
Measured: in 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start1 Jan 2019
- Primary completion30 Jun 2021 (estimated)
- Study completion31 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fusion of SpineStudies 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- I.M. Sechenov First Moscow State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexey Lychagin, MD, PhD, Study chair, IM Sechenov University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04415814
- Sponsor's protocol ID
- 1123
- Status last verified
- Apr 2020
- First submitted
- 23 May 2020
- Last updated
- 25 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unilateral Versus Bilateral Pedicle Screw Fixation for Lumbar Degenerative Diseases
- ClinicalTrials.gov ID
- NCT04415814
- Acronym / sponsor ID
- 1123
- Conditions
- Fusion of Spine
- Keywords
- degenerative spine, unilateral fixation of the spine, fusion of the lumbar spine, posterior stabilization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- I.M. Sechenov First Moscow State Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 31 Aug 2022 (estimated)
- First posted
- 4 Jun 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.
Determining the treatment strategy for patients with degenerative diseases of the spine is extremely difficult, without an accurate understanding of the nature of stress distribution in the vertebral-motor segments of the spine, as well as biomechanical changes that are associated with degenerative diseases of the spine. In this clinical study, we want to compare the use of unilateral and bilateral transpedicular fixation for treating the patients with degenerative diseases of the lumbar spine.
Detailed description
It is planned to use posterior stabilization without interbody fusion. In the postoperative period, all the patients receive antibacterial and analgesic therapy. The early postoperative period is spent in a hospital. Repeated appearances for control examinations (3, 6, 12 months) are provided for physical examination (EQ-5D, Oswestry Disability Index) and performing radiographs or computed tomography (CT) of the spine. All patients undergo a standard rehabilitation course.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (Unilateral Pedicle Screw Fixation) | Experimental | Procedure: Unilateral Pedicle Screw FixationPatients will undergo stabilizing surgery on the lumbar spine for degenerative diseases of the spine. Pedicular screws will be installed unilaterally, which means on one side of the spinous processes. The system will be fixed with standard rod and blockers. |
| Group 2 (Bilateral Pedicle Screw Fixation) | Active comparator | Procedure: Bilateral Pedicle Screw FixationPatients will undergo stabilizing surgery on the lumbar spine for degenerative diseases of the spine. Pedicular screws will be installed bilaterally, which means on the both sides of the spinous processes. The system will be fixed with standard rods and blockers. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Written informed consent of the patient to participate in the study;
- Patients with degenerative diseases of the lumbar spine.
- The opportunity for observation during the entire study period (12 months);
- Mental adequacy, ability, willingness to cooperate and follow the doctor's recommendations.
Key exclusion criteria (5 listed)
- The refusal of a patient from surgery
- The presence of contraindications to surgery
- Severe forms of diabetes (glycosylated hemoglobin >9%);
- Blood diseases (thrombopenia, thrombocytopenia, anemia with Hb< 90g\l);
- The unwillingness of the patient to conscious cooperation.
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 |
|---|---|---|
| Unilateral Pedicle Screw FixationPedicle screws are installed unilaterally on the one side of the vertebrae and fixed with rod | Procedure or surgery | Group 1 (Unilateral Pedicle Screw Fixation) |
| Bilateral Pedicle Screw FixationPedicle screws are installed bilaterally on the both sides of the vertebrae and fixed with rods | Procedure or surgery | Group 2 (Bilateral Pedicle Screw Fixation) |
Primary outcome
fusion rate of the operated spine segment
Time frame: in 3 months after surgery
Control CT/Radiography examination
fusion rate of the operated spine segment
Time frame: in 6 months after surgery
Control CT/Radiography examination
fusion rate of the operated spine segment
Time frame: in 12 months after surgery
Control CT/Radiography examination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2020.
- Individual participant dataSharing planned: No
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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.
Alexey Lychagin, MD, PhD study chair
IM Sechenov University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unilateral Pedicle Screw Fixation and Bilateral Pedicle Screw Fixation in people with Fusion of Spine, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
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 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: status not confirmed, as of the sponsor's last update on 25 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vadim Cherepanov, MD, PhD (+79166548850, cvg_cherepanov@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fusion rate of the operated spine segment (time frame: in 3 months after surgery). The study lists 3 primary outcomes in all. 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 25 Sep 2020.