Evidence map›Paper›PMID 41612848›Full record

Trial reportPM & R : the journal of injury, function, and rehabilitation2026

Minimally invasive sacroiliac joint fusion: Primary endpoint results from the prospective, multicenter STACI study.

Jacqueline Weisbein, Timothy Davis, Douglas Beall, Jack Smith, Caroline Harstroem, Daniel Kloster, Morteza Rabii, Robyn Capobianco, Ramana Naidu, Michael Harned and 2 more

Abstract readMulticenter StudyClinical Trial
In one paragraph

Trial report in PM & R : the journal of injury, function, and rehabilitation, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Trial
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Jacqueline WeisbeinNapa Valley Orthopaedics, Napa, California, USA.
Timothy DavisSource Healthcare, Santa Monica, California, USA.
Douglas BeallClinical Investigations, LLC, Edmond, Oklahoma, USA.
Jack SmithArgires Marotti Neurosurgical Associates of, Lancaster, Lancaster, Pennsylvania, USA.
Caroline HarstroemAnesis Spine & Pain Care, Renton, Washington, USA.
Daniel KlosterCrimson Pain Management Specialists, Overland Park, Kansas, USA.
Morteza RabiiCrimson Pain Management Specialists, Overland Park, Kansas, USA.
Robyn CapobiancoSI-BONE, Inc, Santa Clara, California, USA.ORCID https://orcid.org/0000-0001-9889-2526
Ramana NaiduMarinHealth Spine Institute, Larkspur, California, USA.
Michael HarnedUniversity of Kentucky, Lexington, Kentucky, USA.
Christopher MallardUniversity of Kentucky, Lexington, Kentucky, USA.
STACI investigators

Funding

SI-BONE
6 · The paper itself

Abstract

backgroundChronic sacroiliac joint (SIJ) pain is highly debilitating. Minimally invasive SIJ fusion has become a commonly performed surgical treatment for SIJ pain, with level I evidence showing clinically significant improvements in pain, function, and quality of life and a low adverse event rate. Primarily performed by surgeons, this procedure is increasingly being performed by interventional pain management (IPM) physicians. PURPOSE: To evaluate the safety and effectiveness of lateral SIJ fusion performed by IPM physicians, compared with prior studies of similar devices. STUDY

designProspective, multicenter, single-arm clinical trial conducted at 15 U.S. sites. PATIENT SAMPLE: A total of 112 patients with a diagnosis of SIJ pain, who met study eligibility criteria, underwent lateral SIJ fusion. OUTCOME MEASURES: SIJ pain (numerical rating scale [NRS]), Oswestry Disability Index (ODI), quality of life (Patient-Reported Outcomes Measurement Information System [PROMIS]-29), patient satisfaction, and device/procedure-related adverse events.

methodsMedical and surgical history and patient-reported outcomes were assessed at baseline and follow-up at 1, 3, 6, 12, and 24 months postoperatively. Primary endpoint is change in SIJ pain from baseline to 6 months; statistical evaluation used a noninferiority approach with a 1-point noninferiority margin compared to prior studies of a similar device. Secondary endpoints included ODI, NRS, PROMIS-29, device/procedure-related adverse events, and evidence of fusion via computed tomography scan at 2 years. Twelve- and 24-month follow-up data collection is ongoing.

resultsMean (SD) participant age was 64 (14) years and 68% female. No serious or device-related adverse events occurred. At 6 months, mean SIJ pain decreased 5.2 points (95% confidence interval [CI] 4.7-5.7), meeting the study's primary noninferiority endpoint (p < .001 for noninferiority, p < .001 for change from baseline). A majority (91%) had a ≥2-point improvement in SIJ pain. ODI improved by 25.8 points (95% CI 22.2-29.4, p < .001 vs. baseline).

conclusionInterim trial results support the safety and effectiveness of lateral SIJ fusion performed by IPM physicians. Clinically significant improvements in pain and disability are commensurate with results from surgeon-performed randomized trials and published literature. Results should be reproduced in randomized trials.

Indexed as

Low Back PainMinimally Invasive Surgical ProceduresSacroiliac JointSpinal FusionAdultAgedDisability EvaluationFemaleHumansMaleMiddle AgedPain MeasurementPatient SatisfactionProspective StudiesQuality of LifeTreatment Outcome

Identifiers

PMID41612848
PMCPMC13575448

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.