Trial reportMedical devices (Auckland, N.Z.)2020
Prospective Trial of Sacroiliac Joint Fusion Using 3D-Printed Triangular Titanium Implants.
Trial report in Medical devices (Auckland, N.Z.), 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 1 of them a synthesis that pooled it.
What it found
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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.
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.
Who cites it
14 citing papers in PubMed, 1 synthesis or guideline pooled it, 19 citations in OpenAlex.
- Efficacy of interventions to reduce long term opioid treatment for chronic non-cancer pain: systematic review and meta-analysis.BMJ (Clinical research ed.) · 2022Pooled it
- A Retrospective, Multicenter Analysis of a Novel Sacroiliac Joint Fusion Device on Safety and Efficacy at 12 Months: Access Study.Healthcare (Basel, Switzerland) · 2025Article
- The effect of 3D virtual surgical planning in sacroiliac joint fusion.Brain & spine · 2025Article
- Comparison of two surgical treatment strategies for fragility fractures of the pelvis based on early postoperative mobility outcomes using insole force sensors.Archives of orthopaedic and trauma surgery · 2024Observational
- American Society of Pain and Neuroscience Best Practice (ASPN) Guideline for the Treatment of Sacroiliac Disorders.Journal of pain research · 2024Review
- Potential S1 Nerve Root Blocks Associated with Sacroiliac Joint Injections.Pain research & management · 2024Article
- Minimally Invasive SI Joint Fusion Procedures for Chronic SI Joint Pain: Systematic Review and Meta-Analysis of Safety and Efficacy.International journal of spine surgery · 2023Article
- The Progress in Bioprinting and Its Potential Impact on Health-Related Quality of Life.Bioengineering (Basel, Switzerland) · 2023Review
- An additively manufactured titanium tilting suture anchor: a biomechanical assessment on human and ovine bone specimens.Frontiers in surgery · 2023Article
- The American Society of Pain and Neuroscience (ASPN) Evidence-Based Clinical Guideline of Interventional Treatments for Low Back Pain.Journal of pain research · 2022Review
- Three-Dimensional Printing of Medical Devices Used Directly to Treat Patients: A Systematic Review.3D printing and additive manufacturing · 2021Review
- Applications of nanotechnology in 3D printed tissue engineering scaffolds.European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V · 2021Review
- Prospective Trial of Sacroiliac Joint Fusion Using 3D-Printed Triangular Titanium Implants: 24-Month Follow-Up.Medical devices (Auckland, N.Z.) · 2021Article
- International Society for the Advancement of Spine Surgery Policy 2020 Update-Minimally Invasive Surgical Sacroiliac Joint Fusion (for Chronic Sacroiliac Joint Pain): Coverage Indications, Limitations, and Medical Necessity.International journal of spine surgery · 2020Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors at 11 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundPrior trials provide strong evidence supporting minimally invasive sacroiliac joint (SIJ) fusion using triangular titanium implants (TTI) for chronic SIJ dysfunction.
objectiveTo assess the safety and effectiveness of SIJF using a 3D-printed TTI.
methodsFifty-one subjects with carefully diagnosed SIJ dysfunction underwent SIJF with 3D TTI. Subjects completed pain, disability and quality of life questionnaires at baseline and 3, 6 and 12 months postoperatively. Functional tests were performed in the clinic at each visit. Pelvic CT scans were independently evaluated for radiolucency, bridging bone and other endpoints.
resultsNinety percent had 12-month follow-up. Dysfunction due to pain (Oswestry Disability Index [ODI]) decreased from 52.8 at baseline to 27.9 at 12 months (p<.0001 for change, p=.004 for non-inferiority primary hypothesis). SIJ pain scores improved from 78 preoperatively to 21 at 12-month follow-up (P<.0001). Ninety-six percent experienced an improvement of 20 points or more in VAS SIJ pain by month 12. The percentage of subjects reporting minimal difficulty performing physical activities typically impaired by back/SIJ pain improved significantly for all activities. The proportion of subjects taking opioids for SIJ pain decreased from 57% to 22%. Three physical function tests improved markedly from baseline to 1 year. Positive radiographic findings were observed, including a 70% and 77% rate of bone bridging observed at 6 and 12 months, respectively. There was no evidence of device breakage, migration or subsidence.
conclusionIn this prospective multicenter trial, SIJF with 3D-printed TTI markedly improved pain, disability and quality of life. Results are consistent with 3 prior prospective multicenter trials of a milled implant but suggest accelerated bony fusion with the newer implant. Physical function improved, and high rates of opioid cessation were observed. LEVEL OF EVIDENCE: Level II.
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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.