SacroiliitisNCT05276024
Evaluation of the iFuse Bedrock Technique in Association With Posterior Lumbosacral Fusion With Iliac Fixation.
An observational study of Sacroiliitis and Sacroiliac; Fusion, run by Polyclinique Bordeaux Nord Aquitaine at 2 sites in France.
Trial summary
The purpose of this study is to describe the impact of the iFuse Bedrock technique to decrease post-operative pains in patients who underwent multilevel posterior lumbosacral fusion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sacroiliitis, Sacroiliac; Fusion, Lumbosacral; Fusion
- What is being tested?
- iFuse Bedrock technique
- Type of treatment
- Medical device
- How many people
- 48 participants
- Where
- 2 sitesFrance
- Study dates
- 10 Jun 2022to 1 Apr 2026
- Phase
- Observational
- 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
- Adult, Older adult
Study population: All participants enrolled in the study are adult subjects who underwent an open posterior lumbosacral fusion procedure with additional sacroiliac joint fusion according to the iFuse Bedrock technique (insertion of the iFUSE-3D implant). Lumbosacral fusion involved at least the following vertebrae : L4, L5 and S1.
Who may be able to join
- Subject scheduled for open posterior lumbosacral arthrodesis (including at least the following three vertebrae: L4, L5 and S1) associated with a sacroiliac fusion procedure and iliac fixation (thoracolumbar fusion procedures extended to sacrum are eligible in the study);
- Insertion of at least 1 iFuse-3D implant according to the iFuse Bedrock technique (uni- and bilateral insertion are eligible);
- Subject who preoperatively responded positively to pain provocation tests for SIJ dysfunction with or without a positive SIJ infiltration test;
- Patient with a degenerative sacroiliac joint disease requested a fusion procedure;
Who cannot join
- Major osteoporosis (DEXA scan > 3);
- Any previous history of sacroiliac joint fusion or any surgical procedure involving a S2-iliac fusion;
- Subjects requested a SIJ fusion without the iFuse-3D device or iFuse-3D not inserted according to the manufacturer instruction (Bedrock technique);
- Subjects with a medical or surgical contraindication preventing the intervention from being performed or potentially interfering in the interpretation of the data collected (neurologic condition, local or systemic infection, any known allergy to surgical implants, psychiatric diseases, ...);
- Currently pregnant or planning pregnancy;
- Prisoner or a ward of the state;
- Subject no willing to participate in the study;
- Subject not affiliated to a social security insurance.
Trial locations and contacts
2 sites in 1 country.
France2 sites
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, 33300
Hôpitaux Universitaires de Marseille
Marseille, 13005
About this study
The purpose of this study is to describe the impact of the iFuse Bedrock technique to decrease post-operative pains in patients who underwent multilevel posterior lumbosacral fusion.
Read the detailed description
This study is a multicentric, post-marked clinical investigation to assess the efficacy of the iFuse Bedrock technique to avoid post-operative pains in patients who underwent open posterior multilevel lumbosacral fusion. Subjects will be monitored for lumbar pains (Oswestry score, VAS, SF-12 questionnaire) and sacroiliac joint pains (provocative tests) up to 12 months after initial procedure. A single CT-scan acquisition will be performed at 12 months to detect any iFuse system-related abnormality (implants loosening or breakages).
- Conditions
- Sacroiliitis, Sacroiliac; Fusion, Lumbosacral; Fusion, Spine Deformity
- Being tested
- iFuse Bedrock technique
- Keywords
- Sacroiliac joint pain, Sacroiliac joint fusion, Bedrock technique, Open posterior lumbosacral fusion, Spine deformties
- Medical subject headings
- Sacroiliitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iFuse Bedrock techniqueDevice
Lumbosacral arthrodesis on 2 or more spinal segments (including at least L4, L5 and S1 vertebrae) associated with a sacroiliac fusion procedure according to the Bedrock technique using the iFuse 3D system and iliac fixation.
| Study group | Role | What they receive |
|---|---|---|
| iFuse Bedrock technique | Multilevel lumbar fusion procedure with additional sacroiliac joint stabilization using the iFuse-3D system Receives: Device: iFuse Bedrock technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in self-reported Oswestry Disability Index (ODI) at 12 months
A decrease of 16 points in the ODI score at 12 months compared to the preoperative score is expected in order to demonstrate a 30% effecacy of the iFuse Bedrock technique in reducing postoperative pain.
Measured: 12 months
Secondary outcomes (14)
Change from baseline in sacroiliac joint pain provocation tests.
The number of positive SIJ pain provocation tests (Östgaard test, Faber test, Gaenslen test, Lasegue test, Compression, Long ligament test) performed at 3, 6 and 12 months will be compared against baseline (preoperative).
Measured: During 12 months
Assessment of the Oswestry Disability Index
Change from baseline in self reported Oswestry Disability Index (ODI) score at 3 and 6 months.
Measured: 3 and 6 months
Improvement of back and leg pains at 3, 6 and 12 months compared to preoperative scores
Back and leg pain intensity self-report will be assessed before and after initial procedure for each patient (at 3, 6 and 12 months) using a 0 to 10 visual analog scale (0: no pain ; 10: most imaginable pain).
Measured: 3, 6 and 12 months
Change in Patient's quality of life
Change from baseline in self reported 12-Item Short Form Survey (SF-12) score at 3, 6 and 12 months.
Measured: 3, 6 and 12 months
Proportion of subjects with postoperative SIJ fusion failure
Proportion of subjects with SIJ fusion failure on CT scan as interpreted by the investigator
Measured: 12 months
Impact of iFuse Bedrock technique on Pelvic Incidence
Measurement of postoperative Pelvic Incidence (PI) using EOS stereography at 3, 6 and 12 months compared to baseline.
Pelvic Incidence is the angle between the line perpendicular to the S1 endplate from the midpoint of the endplate and the connecting line from the midpoint of the S1 endplate to center of the femoral head.
Measured: During 12 months
Impact of iFuse Bedrock technique on Pelvic Tilt
Measurement of postoperative Pelvic Tilt (PT) using EOS stereography at 3, 6 and 12 months compared to baseline.
Pelvic Tilt is the angle between the connecting line from the midpoint of the S1 endplate to the center of the femoral head and the vertical line.
Measured: During 12 months
Impact of iFuse Bedrock technique on Sacral Slope
Measurement of postoperative Sacral Slope (SS) using EOS stereography at 3, 6 and 12 months compared to baseline.
Sacral Slope is the angle between the tangent and the horizontal line of S1 endplate.
Measured: During 12 months
Impact of iFuse Bedrock technique on Lumbar Lordosis
Measurement of postoperative Lumbar Lordosis (LL) using EOS stereography at 3, 6 and 12 months compared to baseline.
Lumbar Lordosis is the angle between the L1 upper endplate and the S1 upper endplate.
Measured: During 12 months
Impact of iFuse Bedrock technique on Thoracic Kyphosis
Measurement of postoperative Thoracic Kyphosis (TK) using EOS stereography at 3, 6 and 12 months compared to baseline.
Thoracic Kyphosis is the angle between the T4 upper endplate and the T12 lower endplate.
Measured: During 12 months
Impact of iFuse Bedrock technique on the Odontoid Hip Axis
Measurement of postoperative Odontoid Hip Axis (OD-HA) using EOS stereography at 3, 6 and 12 months compared to baseline.
Odontoid Hip Axis is the angle between the vertical and the highest point of the odontoid process (dens) connecting to the centre of the acetabulum (bi-coxo-femoral axis)
Measured: During 12 months
Impact of iFuse Bedrock technique on the T1 pelvic angle
Measurement of postoperative T1 pelvic angle (TPA) using EOS stereography at 3, 6 and 12 months compared to baseline.
TPA is the angle between the line from centroid of T1 to the femoral head axis and the line from femoral head axis to middle of the S1 endplate
Measured: During 12 months
Proportion of subjects with iFuse-3D implant-related complications
Proportion of subjects with any of the following complications related to the iFuse-3D implant : malposition of the implant (intra-operative evaluation), loosening, displacement, abnormal bone reaction, breakage or any other complication directly related to the insertion or use of the iFuse-3D implant.
Measured: 12 months
Incidence of any serious adverse events
Record of any intra and postoperative complications
Measured: During 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2022
- Study start10 Jun 2022
- Primary completion1 Apr 2026
- Study completion1 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SacroiliitisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Polyclinique Bordeaux Nord Aquitaine
- Sponsor type
- University, hospital or other
- Collaborators
- SI-BONE, Inc.
- Responsible party
- Sponsor
- Investigators
- Jean Charles Le Huec, M.D., PhD, Principal investigator, VERTEBRA Institute, Polyclinique Bordeaux Nord Aquitaine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05276024
- Sponsor's protocol ID
- 2021-ORT03
- Status last verified
- Oct 2026
- First submitted
- 21 Feb 2022
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the iFuse Bedrock Technique in Association With Posterior Lumbosacral Fusion With Iliac Fixation.
- ClinicalTrials.gov ID
- NCT05276024
- Acronym / sponsor ID
- 2021-ORT03
- Conditions
- Sacroiliitis, Sacroiliac; Fusion, Lumbosacral; Fusion, Spine Deformity
- Keywords
- Sacroiliac joint pain, Sacroiliac joint fusion, Bedrock technique, Open posterior lumbosacral fusion, Spine deformties
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Polyclinique Bordeaux Nord AquitaineUniversity, hospital or other
- Collaborators
- SI-BONE, Inc.
- Study start
- 10 Jun 2022 (actual)
- Primary completion
- 1 Apr 2026 (actual)
- Study completion
- 1 Apr 2026 (actual)
- First posted
- 11 Mar 2022 (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 describe the impact of the iFuse Bedrock technique to decrease post-operative pains in patients who underwent multilevel posterior lumbosacral fusion.
Detailed description
This study is a multicentric, post-marked clinical investigation to assess the efficacy of the iFuse Bedrock technique to avoid post-operative pains in patients who underwent open posterior multilevel lumbosacral fusion. Subjects will be monitored for lumbar pains (Oswestry score, VAS, SF-12 questionnaire) and sacroiliac joint pains (provocative tests) up to 12 months after initial procedure. A single CT-scan acquisition will be performed at 12 months to detect any iFuse system-related abnormality (implants loosening or breakages).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| iFuse Bedrock technique | – | Device: iFuse Bedrock techniqueMultilevel lumbar fusion procedure with additional sacroiliac joint stabilization using the iFuse-3D system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All participants enrolled in the study are adult subjects who underwent an open posterior lumbosacral fusion procedure with additional sacroiliac joint fusion according to the iFuse Bedrock technique (insertion of the iFUSE-3D implant). Lumbosacral fusion involved at least the following vertebrae : L4, L5 and S1.
Key inclusion criteria (4 listed)
- Subject scheduled for open posterior lumbosacral arthrodesis (including at least the following three vertebrae: L4, L5 and S1) associated with a sacroiliac fusion procedure and iliac fixation (thoracolumbar fusion procedures extended to sacrum are eligible in the study);
- Insertion of at least 1 iFuse-3D implant according to the iFuse Bedrock technique (uni- and bilateral insertion are eligible);
- Subject who preoperatively responded positively to pain provocation tests for SIJ dysfunction with or without a positive SIJ infiltration test;
- Patient with a degenerative sacroiliac joint disease requested a fusion procedure;
Key exclusion criteria (8 listed)
- Major osteoporosis (DEXA scan > 3);
- Any previous history of sacroiliac joint fusion or any surgical procedure involving a S2-iliac fusion;
- Subjects requested a SIJ fusion without the iFuse-3D device or iFuse-3D not inserted according to the manufacturer instruction (Bedrock technique);
- Subjects with a medical or surgical contraindication preventing the intervention from being performed or potentially interfering in the interpretation of the data collected (neurologic condition, local or systemic infection, any known allergy to surgical implants, psychiatric diseases, ...);
- Currently pregnant or planning pregnancy;
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 |
|---|---|---|
| iFuse Bedrock techniqueLumbosacral arthrodesis on 2 or more spinal segments (including at least L4, L5 and S1 vertebrae) associated with a sacroiliac fusion procedure according to the Bedrock technique using the iFuse 3D system and iliac fixation. | Device | iFuse Bedrock technique |
Primary outcome
Change from baseline in self-reported Oswestry Disability Index (ODI) at 12 months
Time frame: 12 months
A decrease of 16 points in the ODI score at 12 months compared to the preoperative score is expected in order to demonstrate a 30% effecacy of the iFuse Bedrock technique in reducing postoperative pain.
14 secondary outcomes
Change from baseline in sacroiliac joint pain provocation tests.
Time frame: During 12 months
Assessment of the Oswestry Disability Index
Time frame: 3 and 6 months
Improvement of back and leg pains at 3, 6 and 12 months compared to preoperative scores
Time frame: 3, 6 and 12 months
Change in Patient's quality of life
Time frame: 3, 6 and 12 months
Proportion of subjects with postoperative SIJ fusion failure
Time frame: 12 months
Impact of iFuse Bedrock technique on Pelvic Incidence
Time frame: During 12 months
Impact of iFuse Bedrock technique on Pelvic Tilt
Time frame: During 12 months
Impact of iFuse Bedrock technique on Sacral Slope
Time frame: During 12 months
Impact of iFuse Bedrock technique on Lumbar Lordosis
Time frame: During 12 months
Impact of iFuse Bedrock technique on Thoracic Kyphosis
Time frame: During 12 months
Impact of iFuse Bedrock technique on the Odontoid Hip Axis
Time frame: During 12 months
Impact of iFuse Bedrock technique on the T1 pelvic angle
Time frame: During 12 months
Proportion of subjects with iFuse-3D implant-related complications
Time frame: 12 months
Incidence of any serious adverse events
Time frame: During 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- 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.
Jean Charles Le Huec, M.D., PhD principal investigator
VERTEBRA Institute, Polyclinique Bordeaux Nord Aquitaine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sacroiliitis and Sacroiliac; Fusion, run by Polyclinique Bordeaux Nord Aquitaine at 2 sites in France.
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 8 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: finished, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 self-reported Oswestry Disability Index (ODI) at 12 months (time frame: 12 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 8 Oct 2026.