Evidence map›Paper›PMID 27179664›Full record

Trial reportEuropean spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society2017

Six-month outcomes from a randomized controlled trial of minimally invasive SI joint fusion with triangular titanium implants vs conservative management.

Bengt Sturesson, Djaya Kools, Robert Pflugmacher, Alessandro Gasbarrini, Domenico Prestamburgo, Julius Dengler

Registry-linked trialOpen access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01741025 (A Multicenter Randomized Controlled Post-market Clinical Follow-up Trial Comparing the Effectiveness and Safety of the iFuse Implant System® Versus Conservative Management for Patients With Chronic, Disabling SI Joint Pain.), which is not on this map. Cited by 53 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
53citing papers in PubMed, 4 pooled it
11.1field-weighted citation impact, top 1% of its field
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.

NCT01741025 nacompletednot on this map

A Multicenter Randomized Controlled Post-market Clinical Follow-up Trial Comparing the Effectiveness and Safety of the iFuse Implant System® Versus Conservative Management for Patients With Chronic, Disabling SI Joint Pain.

TypeinterventionalSponsorSI-BONE, Inc.Ran2013 to 2017Enrolled103ConditionsSacroiliac Joint PainArmsiFuse Implant System, Conservative Management
3 · Its place in the literature

Who cites it

53 citing papers in PubMed, 4 syntheses or guidelines pooled it, 102 citations in OpenAlex.

  1. Guideline
  2. Management of sacroiliac joint pain: current concepts.European journal of orthopaedic surgery & traumatology : orthopedie traumatologie · 2025
    Pooled it
  3. The efficacy of primary sacroiliac joint fusion for low back pain caused by sacroiliac joint pathology: a systematic review and meta-analysis.European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society · 2022
    Pooled it
  4. Pooled it
  5. Trial
  6. Trial
  7. Radiographic signs of implant loosening in sacroiliac joint fusion: an 11-year retrospective cohort study.European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society · 2026
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  20. Beyond the pedicle screw-a patent review.European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society · 2022
    Review
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

6 authors at 6 institutions in 4 countries.

Bengt SturessonDepartment of Orthopedics, Aleris, Ängelholm Hospital, Ängelholm, Sweden. sturesson.bengt@gmail.com.
Djaya KoolsDepartment of Neurosurgery, Onze-Lieve-Vrouw Hospital Aalst, Aalst, Belgium.
Robert PflugmacherDepartment of Orthopedics and Traumatology, University Hospital Bonn, Bonn, Germany.
Alessandro GasbarriniInstituto Ortopedico Rizzoli di Bologna, Bologna, Italy.
Domenico PrestamburgoDepartment of Orthopedics and Traumatology, ASST Ovest Milanese, Ospedale di Legnano, Legnano, Italy.
Julius DenglerDepartment of Neurosurgery, Charité, Universitaetsmedizin Berlin, Berlin, Germany.
Aziende Socio Sanitarie Territoriale Ovest MilaneseCharité - Universitätsmedizin Berlin · DEHässleholms Sjukhus · SEIstituto Ortopedico Rizzoli · ITOnze Lieve Vrouwziekenhuis Hospital · BEUniversity Hospital Bonn · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo compare the safety and effectiveness of minimally invasive sacroiliac joint fusion (SIJF) using triangular titanium implants vs conservative management (CM) in patients with chronic sacroiliac joint (SIJ) pain.

methods103 adults with chronic SIJ pain at nine sites in four European countries were randomly assigned to and underwent either minimally invasive SIJF using triangular titanium implants (N = 52) or CM (N = 51). CM was performed according to the European guidelines for the diagnosis and management of pelvic girdle pain and consisted of optimization of medical therapy, individualized physical therapy (PT) and adequate information and reassurance as part of a multifactorial treatment. The primary outcome was the difference in change in self-rated low back pain (LBP) at 6 months. Additional endpoints included quality of life using EQ-5D-3L, disability using Oswestry Disability Index (ODI), SIJ function using active straight leg raise (ASLR) test and adverse events. NCT01741025.

resultsAt 6 months, mean LBP improved by 43.3 points in the SIJF group and 5.7 points in the CM group (difference of 38.1 points, p < 0.0001). Mean ODI improved by 26 points in the SIJF group and 6 points in the CM group (p < 0.0001). ASLR, EQ-5D-3L, walking distance and satisfaction were statistically superior in the SIJF group. The frequency of adverse events did not differ between groups. One case of postoperative nerve impingement occurred in the surgical group.

conclusionsIn patients with chronic SIJ pain, minimally invasive SIJF using triangular titanium implants was safe and more effective than CM in relieving pain, reducing disability, improving patient function and quality of life.

Indexed as

Physical Therapy ModalitiesSpinal FusionAdultAgedConservative TreatmentDisability EvaluationFemaleHumansLow Back PainMiddle AgedMinimally Invasive Surgical ProceduresProspective StudiesProstheses and ImplantsQuality of LifeSacroiliac JointTitaniumTitaniumConservative managementiFuse Implant SystemPelvic girdle painRandomized controlled trialSacroiliac joint dysfunctionSacroiliac joint fusionTitanium sacroiliac implant

Identifiers

PMID27179664
OpenAlexW2383118866

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

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.