Sacroiliac Joint DysfunctionINSPIRENCT06706908
Innovative Spinopelvic Solutions With Real-World Evidence
An observational study of Sacroiliac Joint Dysfunction and Sacroiliac Joint Pain, run by SI-BONE, Inc. at 1 site in United States.
Trial summary
INSPIRE is a prospective decentralized study evaluating post-operative health outcomes in patients who undergo a procedure using implants manufactured by SI-BONE. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Sacroiliac Joint Dysfunction, Sacroiliac Joint Pain
- What is being tested?
- Health questionnaires
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2024to Dec 2034
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients treated with an implant manufactured by SI-BONE.
Who may be able to join
- Age > 21 at time of screening.
- Patient will undergo a procedure utilizing an iFuse Implant family product.
- Patient is comfortable communicating in written and spoken English.
- Patient is willing and able to complete study questionnaires online, using either a smartphone, tablet, or computer.
- Patient is willing and able to provide informed consent to participate
Who cannot join
- Patient has fibromyalgia.
- Patient has a pain pump.
- Patient is currently receiving or seeking worker's compensation, disability remuneration, and/or involved in injury litigation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Innovative Spinopelvic Solutions With Real-world Evidence
INSPIRE is a prospective decentralized study evaluating post-operative health outcomes in patients who undergo a procedure using implants manufactured by SI-BONE.
- Being tested
- Health questionnaires
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health questionnairesOther
Participants are expected to complete a series of health questionnaires (i.e. numerical rating scale, Oswestry Disability Index) relevant to their treatment using a SI-BONE implant.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in patient reported outcomes
Change in pain as rated on a numerical rating scale (NRS), 0 being no pain and 10 being the worst pain imaginable at baseline and follow-up timepoints.
Measured: From enrollment and at the following timepoints, 1-, 3-, 6-, and 12-months.
Secondary outcomes (1)
Change in patient reported outcomes
Change in patient satisfaction on a four point scale, with 0 being very dissatisfied and 3 being very satisfied at follow-up timepoints.
Measured: At the following timepoints: 1-, 3-, 6-, and 12-months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2024
- Study start15 Dec 2024
- Primary completionDec 2034 (estimated)
- Study completionDec 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sacroiliac Joint DysfunctionStudies 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
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SI-BONE, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robyn Capobianco, PhD, Principal investigator, SI-BONE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06706908
- Sponsor's protocol ID
- 302022
- Acronym
- INSPIRE
- Status last verified
- Apr 2026
- First submitted
- 22 Nov 2024
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovative Spinopelvic Solutions With Real-world Evidence
- ClinicalTrials.gov ID
- NCT06706908
- Acronym / sponsor ID
- INSPIRE / 302022
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- SI-BONE, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Dec 2024 (actual)
- Primary completion
- Dec 2034 (estimated)
- Study completion
- Dec 2034 (estimated)
- First posted
- 27 Nov 2024 (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.
INSPIRE is a prospective decentralized study evaluating post-operative health outcomes in patients who undergo a procedure using implants manufactured by SI-BONE.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated with an implant manufactured by SI-BONE.
Key inclusion criteria (5 listed)
- Age > 21 at time of screening.
- Patient will undergo a procedure utilizing an iFuse Implant family product.
- Patient is comfortable communicating in written and spoken English.
- Patient is willing and able to complete study questionnaires online, using either a smartphone, tablet, or computer.
- Patient is willing and able to provide informed consent to participate
Key exclusion criteria (3 listed)
- Patient has fibromyalgia.
- Patient has a pain pump.
- Patient is currently receiving or seeking worker's compensation, disability remuneration, and/or involved in injury litigation
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 |
|---|---|---|
| Health questionnairesParticipants are expected to complete a series of health questionnaires (i.e. numerical rating scale, Oswestry Disability Index) relevant to their treatment using a SI-BONE implant. | Other | – |
Primary outcome
Change in patient reported outcomes
Time frame: From enrollment and at the following timepoints, 1-, 3-, 6-, and 12-months.
Change in pain as rated on a numerical rating scale (NRS), 0 being no pain and 10 being the worst pain imaginable at baseline and follow-up timepoints.
1 secondary outcome
Change in patient reported outcomes
Time frame: At the following timepoints: 1-, 3-, 6-, and 12-months.
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 24 Apr 2026.
- Individual participant dataSharing planned: Undecided
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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 principal investigator
SI-BONE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sacroiliac Joint Dysfunction and Sacroiliac Joint Pain, run by SI-BONE, Inc. at 1 site 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 5 inclusion and 3 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 24 Apr 2026. 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 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?
Change in patient reported outcomes (time frame: From enrollment and at the following timepoints, 1-, 3-, 6-, and 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 24 Apr 2026.