Spinal FusionPAULANCT05640908
Pelvic Fixation and Fusion During Multilevel Spinal Surgery
An observational study of Spinal Fusion and Deformity of Spine, run by SI-BONE, Inc. at 9 sites in United States.
Trial summary
PAULA aims to collect data on the safety, performance, and effectiveness of iFuse Bedrock Granite (GRANITE) in patients who have spinal fusion surgery with pelvic fixation/ fusion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Fusion, Deformity of Spine
- What is being tested?
- iFuse Bedrock Granite Implant System
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 9 sitesUnited States
- Study dates
- 5 Jun 2023to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Patients with spinal fusion including pelvic fixation/fusion using GRANITE
Who may be able to join
- ≥ 18 years of age at screening.
- Patient is scheduled for spinal fusion with pelvic fixation/fusion using iFuse Bedrock Granite
- Patient is willing and able to provide written informed consent
Who cannot join
- Any known anatomic issues or permanent implants already in the pelvis that could interfere with placement of the study device(s)
- Prominent neurologic or uncontrolled psychiatric condition that would interfere with study participation
- Known allergy to titanium or titanium alloys
- Current local or systemic infection that raises the risk of surgery
- Currently pregnant or planning pregnancy in the next 2 years
- Known or suspected active drug or alcohol abuse, including opioids
- Patient is a prisoner or ward of the state
- Patient is enrolled in an investigational clinical trial related to the spine
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
University of Colorado School of Medicine
Aurora, Colorado, 80045
University at Buffalo
Buffalo, New York, 14203
University of Texas Health, Houston
Houston, Texas, 77030
University of Minnesota
Minneapolis, Minnesota, 55454
USA Neurosurgery
Mobile, Alabama, 36688
Northwell Health
New York, New York, 10075
Pinehurst Surgical Clinic
Pinehurst, North Carolina, 28374
Texas Back Institute
Plano, Texas, 75093
Corewell Health
Royal Oak, Michigan, 48073
About this study
PAULA aims to collect data on the safety, performance, and effectiveness of iFuse Bedrock Granite (GRANITE) in patients who have spinal fusion surgery with pelvic fixation/ fusion.
Read the detailed description
PAULA is a multicenter, open label, single-arm observational clinical study consisting of prospective and retrospective study cohorts. The goal of the study is to collect data on the safety, performance, and effectiveness of GRANITE.
- Conditions
- Spinal Fusion, Deformity of Spine
- Being tested
- iFuse Bedrock Granite Implant System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iFuse Bedrock Granite Implant SystemDevice
Also called GRANITE, Bedrock Granite
Surgical procedure of the spine with pelvic fixation/fusion using iFuse Bedrock Granite
| Study group | Role | What they receive |
|---|---|---|
| Prospective | Participants who have scheduled spinal fusion with pelvic fixation/fusion using iFuse Bedrock Granite. These participants will be followed for 2 years. Receives: Device: iFuse Bedrock Granite Implant System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative incidence of serious adverse events probably or definitely related to GRANITE
Measured: 2 years
Postoperative incidence of SI joint pain in subject without SI joint pain at baseline
Measured: 2 years
Postoperative incidence of L5-S1 pseudoarthrosis
Measured: 2 years
Postoperative incidence of pelvic construct failure
Failure is defined as:
- Breakage of any implants placed into sacrum or ilium
- Rod breakage in the lumbosacral region
- Pelvic implant loosening that either causes new or worsened pain or requires surgical adjustment/revision
Measured: 2 years
Postoperative incidence of device failures related to GRANITE (e.g., rod disengagement, screw pullout)
Measured: 2 years
Radiographic
Bony apposition to the implant at 12 and 24 months as assessed by CT scan
Measured: 12 month and 24 months
Change in Quality of Life PROs
Scores on PROs at follow up timepoints compared to baseline
Measured: 6 month, 12 month and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2022
- Study start5 Jun 2023
- Primary completionNov 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal FusionStudies 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SI-BONE, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robyn Capobianco, PhD, Study director, SI-BONE, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05640908
- Sponsor's protocol ID
- 301106
- Acronym
- PAULA
- Status last verified
- Jan 2026
- First submitted
- 28 Nov 2022
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pelvic Fixation and Fusion During Multilevel Spinal Surgery
- ClinicalTrials.gov ID
- NCT05640908
- Acronym / sponsor ID
- PAULA / 301106
- Conditions
- Spinal Fusion, Deformity of Spine
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- SI-BONE, Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Jun 2023 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 7 Dec 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.
PAULA aims to collect data on the safety, performance, and effectiveness of iFuse Bedrock Granite (GRANITE) in patients who have spinal fusion surgery with pelvic fixation/ fusion.
Detailed description
PAULA is a multicenter, open label, single-arm observational clinical study consisting of prospective and retrospective study cohorts. The goal of the study is to collect data on the safety, performance, and effectiveness of GRANITE.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prospective | – | Device: iFuse Bedrock Granite Implant SystemParticipants who have scheduled spinal fusion with pelvic fixation/fusion using iFuse Bedrock Granite. These participants will be followed for 2 years. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with spinal fusion including pelvic fixation/fusion using GRANITE
Key inclusion criteria (3 listed)
- ≥ 18 years of age at screening.
- Patient is scheduled for spinal fusion with pelvic fixation/fusion using iFuse Bedrock Granite
- Patient is willing and able to provide written informed consent
Key exclusion criteria (8 listed)
- Any known anatomic issues or permanent implants already in the pelvis that could interfere with placement of the study device(s)
- Prominent neurologic or uncontrolled psychiatric condition that would interfere with study participation
- Known allergy to titanium or titanium alloys
- Current local or systemic infection that raises the risk of surgery
- Currently pregnant or planning pregnancy in the next 2 years
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 Granite Implant SystemAlso: GRANITE, Bedrock GraniteSurgical procedure of the spine with pelvic fixation/fusion using iFuse Bedrock Granite | Device | Prospective |
Primary outcome
Postoperative incidence of serious adverse events probably or definitely related to GRANITE
Time frame: 2 years
Postoperative incidence of SI joint pain in subject without SI joint pain at baseline
Time frame: 2 years
Postoperative incidence of L5-S1 pseudoarthrosis
Time frame: 2 years
Postoperative incidence of pelvic construct failure
Time frame: 2 years
Failure is defined as: * Breakage of any implants placed into sacrum or ilium * Rod breakage in the lumbosacral region * Pelvic implant loosening that either causes new or worsened pain or requires surgical adjustment/revision
Postoperative incidence of device failures related to GRANITE (e.g., rod disengagement, screw pullout)
Time frame: 2 years
Radiographic
Time frame: 12 month and 24 months
Bony apposition to the implant at 12 and 24 months as assessed by CT scan
Change in Quality of Life PROs
Time frame: 6 month, 12 month and 24 months
Scores on PROs at follow up timepoints compared to baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 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.
Robyn Capobianco, PhD study director
SI-BONE, Inc.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Fusion and Deformity of Spine, run by SI-BONE, Inc. at 9 sites in United States.
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 3 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: under way, not looking for participants, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. 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?
This study is still under way. Results are not available in the source record yet.
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?
Postoperative incidence of serious adverse events probably or definitely related to GRANITE (time frame: 2 years). The study lists 7 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 23 Jan 2026.