Degeneration SpinePSEUDOLUSENCT04308018
Primary Sacroiliac Fusion Versus Fusion to the Sacrum for Degenerative Disease of the Lumbar Spine
A study testing S2alar-iliac screws and S1 screws in people with Degeneration Spine, run by Technical University of Munich.
Trial summary
To prove that the use of additional S2alar-iliac screws for pure lumbar fusions due to degenerative lumbar disease provides superior outcome compared to the standard procedure of fusion to S1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Degeneration Spine
- What is being tested?
- S2alar-iliac screws and S1 screws
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- No sites listed yet
- Study dates
- Aug 2020to Aug 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with symptomatic degenerative spine disease with or without spinal stenosis undergoing lumbosacral fusion to S1
- Lumbar or thoracolumbar Instrumentation
- Planned ventral intervertebral fusion (ALIF, TLIF, PLIF) in L5/S1
- Age ≥ 18 years
Who cannot join
- Scoliosis >20°
- Chronic steroid usage
- Significant co-morbidity influencing the surgical success:
- Osteoporosis
- Rheumatoid arthritis
- Mental illness/dementia
Trial locations and contacts
No sites are listed yet.
About this study
To prove that the use of additional S2alar-iliac screws for pure lumbar fusions due to degenerative lumbar disease provides superior outcome compared to the standard procedure of fusion to S1.
Read the detailed description
Patients with symptomatic degenerative spine disease with or without spinal stenosis undergoing lumbosacral fusion to S1. Pedicle screws for posterior Instrumentation and fusion of the lumbar spine plus intervertebral fusion L5/S1 (anterior lumbar inter body fusion (ALIF), transforaminal lumbar inter body fusion (TLIF), or posterior lumbar inter body fusion (PLIF)) with
- Caudal end of the instrumentation at S1
- Caudal end of the instrumentation at iliac bone via S2alar-iliac screws
Stratification of both groups by:
- Number of instrumented levels
- Sagittal balance (Roussouly type 1+2 vs. 3+4)
Prospective, randomized, controlled, rater-blinded multicentric interventional study with two parallel groups
- Conditions
- Degeneration Spine
- Being tested
- S2alar-iliac screws, S1 screws
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S2alar-iliac screwsProcedure or surgery
Caudal end of the instrumentation at iliac bone via S2alar-iliac screws
S1 screwsProcedure or surgery
Caudal end of the instrumentation at S1
| Study group | Role | What they receive |
|---|---|---|
| S1 | Active comparator | Caudal end of the instrumentation at S1 Receives: Procedure: S1 screws |
| S2alar-iliac | Active comparator | Caudal end of the instrumentation at iliac bone via S2alar-iliac screws Receives: Procedure: S2alar-iliac screws |
What is being measured
The primary outcome is the main question the study is designed to answer.
Revision rate
Revisions rates between groups 1 year after surgery
Measured: 1 year after surgery
Secondary outcomes (15)
Inter-group Oswestry disability index (ODI)
Difference in Oswestry disability index (ODI) between groups 3, 6, 12, and 24 months after surgery
Measured: 3, 6, 12, and 24 months after surgery
British Medical Research Council (BMRC) scale
BMRC scale 3, 6, 12, and 24 months after surgery
Measured: 3, 6, 12, and 24 months after surgery
Severe adverse events
(Severe adverse events) SAE due to instrumentation (new neurological deficit, infection, vascular complications, etc.)
Measured: 3, 6, 12, and 24 months after surgery
Back pain intensity
Back pain intensity at the visual analogue scale (VAS; 0-10; high scores mean a worse outcome) 3, 6, 12, and 24 months after surgery
Measured: 3, 6, 12, and 24 months after surgery
Health-related quality of life
Health-related quality of life evaluated by the "physical component summary (PCS)" of the short-form (SF)-36 3, 6, 12, and 24 months after surgery
Measured: 3, 6, 12, and 24 months after surgery
Patient satisfaction
Patient satisfaction index 3, 6, 12, and 24 months after surgery
Measured: 3, 6, 12, and 24 months after surgery
Intra-group Oswestry disability index (ODI)
Difference in ODI 3, 6, 12, and 24 months after surgery versus preoperatively within the same group
Measured: 3, 6, 12, and 24 months after surgery
Revision rate II
Revisions rates between groups 24 months after surgery
Measured: 24 months after surgery
Sacroiliac joint syndrome
Clinically apparent sacroiliac joint syndrome (Definition: Effective infiltration of local anesthetic) 3, 6, 12, and 24 months after surgery
Measured: 3, 6, 12, and 24 months after surgery
Gluteal pain
Gluteal pain at the visual analogue scale (VAS; 0-10; high scores mean a worse outcome) 3, 6, 12, and 24 months after surgery
Measured: 3, 6, 12, and 24 months after surgery
Changes in sagittal balance
Changes in sagittal balance (C7 plumb line, pelvic tilt, pelvic incidence, sacral slope, and lumbar lordosis) 1 and 2 years after surgery versus preoperatively within the same group
Measured: 1 and 2 years after surgery
Progressive degeneration of the adjacent segment
Radiological proof of progressive degeneration of the adjacent segment
Measured: 3, 6, 12, and 24 months after surgery
Surgery duration
Surgery duration
Measured: Surgery
Intraoperative blood loss
Intraoperative blood loss
Measured: Intraoperative
Adverse events
Adverse events
Measured: 3, 6, 12, and 24 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 posted13 Mar 2020
- Study startAug 2020 (estimated)
- Primary completionAug 2021 (estimated)
- Study completionAug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degeneration SpineStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 148 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sandro Krieg, MD, Principal investigator, Technical University Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04308018
- Sponsor's protocol ID
- 20/20
- Acronym
- PSEUDOLUSE
- Status last verified
- Mar 2020
- First submitted
- 21 Nov 2019
- Last updated
- 13 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Sacroiliac Fusion Versus Fusion to the Sacrum for Degenerative Disease of the Lumbar Spine
- ClinicalTrials.gov ID
- NCT04308018
- Acronym / sponsor ID
- PSEUDOLUSE / 20/20
- Conditions
- Degeneration Spine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 148 participants (estimated)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- Aug 2020 (estimated)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Aug 2023 (estimated)
- First posted
- 13 Mar 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.
To prove that the use of additional S2alar-iliac screws for pure lumbar fusions due to degenerative lumbar disease provides superior outcome compared to the standard procedure of fusion to S1.
Detailed description
Patients with symptomatic degenerative spine disease with or without spinal stenosis undergoing lumbosacral fusion to S1. Pedicle screws for posterior Instrumentation and fusion of the lumbar spine plus intervertebral fusion L5/S1 (anterior lumbar inter body fusion (ALIF), transforaminal lumbar inter body fusion (TLIF), or posterior lumbar inter body fusion (PLIF)) with
- Caudal end of the instrumentation at S1
- Caudal end of the instrumentation at iliac bone via S2alar-iliac screws
Stratification of both groups by:
- Number of instrumented levels
- Sagittal balance (Roussouly type 1+2 vs. 3+4)
Prospective, randomized, controlled, rater-blinded multicentric interventional study with two parallel groups
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| S1 | Active comparator | Procedure: S1 screwsCaudal end of the instrumentation at S1 |
| S2alar-iliac | Active comparator | Procedure: S2alar-iliac screwsCaudal end of the instrumentation at iliac bone via S2alar-iliac screws |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with symptomatic degenerative spine disease with or without spinal stenosis undergoing lumbosacral fusion to S1
- Lumbar or thoracolumbar Instrumentation
- Planned ventral intervertebral fusion (ALIF, TLIF, PLIF) in L5/S1
- Age ≥ 18 years
Key exclusion criteria (6 listed)
- Scoliosis >20°
- Chronic steroid usage
- Significant co-morbidity influencing the surgical success:
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 |
|---|---|---|
| S2alar-iliac screwsCaudal end of the instrumentation at iliac bone via S2alar-iliac screws | Procedure or surgery | S2alar-iliac |
| S1 screwsCaudal end of the instrumentation at S1 | Procedure or surgery | S1 |
Primary outcome
Revision rate
Time frame: 1 year after surgery
Revisions rates between groups 1 year after surgery
15 secondary outcomes
Inter-group Oswestry disability index (ODI)
Time frame: 3, 6, 12, and 24 months after surgery
British Medical Research Council (BMRC) scale
Time frame: 3, 6, 12, and 24 months after surgery
Severe adverse events
Time frame: 3, 6, 12, and 24 months after surgery
Back pain intensity
Time frame: 3, 6, 12, and 24 months after surgery
Health-related quality of life
Time frame: 3, 6, 12, and 24 months after surgery
Patient satisfaction
Time frame: 3, 6, 12, and 24 months after surgery
Intra-group Oswestry disability index (ODI)
Time frame: 3, 6, 12, and 24 months after surgery
Revision rate II
Time frame: 24 months after surgery
Sacroiliac joint syndrome
Time frame: 3, 6, 12, and 24 months after surgery
Gluteal pain
Time frame: 3, 6, 12, and 24 months after surgery
Changes in sagittal balance
Time frame: 1 and 2 years after surgery
Progressive degeneration of the adjacent segment
Time frame: 3, 6, 12, and 24 months after surgery
Surgery duration
Time frame: Surgery
Intraoperative blood loss
Time frame: Intraoperative
Adverse events
Time frame: 3, 6, 12, and 24 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2020.
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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.
Sandro Krieg, MD principal investigator
Technical University Munich
Questions about this trial
What is this clinical trial studying?
A study testing S2alar-iliac screws and S1 screws in people with Degeneration Spine, run by Technical University of Munich.
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: status not confirmed, as of the sponsor's last update on 13 Mar 2020. 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 Sandro Krieg, MD (8941402151, sandro.krieg@tum.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Revision rate (time frame: 1 year after surgery). 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 13 Mar 2020.