Evidence map›Paper›PMID 31576181›Full record

ArticleMedical devices (Auckland, N.Z.)2019

Long-Term Prospective Clinical And Radiographic Outcomes After Minimally Invasive Lateral Transiliac Sacroiliac Joint Fusion Using Triangular Titanium Implants.

Peter G Whang, Emily Darr, S Craig Meyer, Don Kovalsky, Clay Frank, Harry Lockstadt, Robert Limoni, Andy J Redmond, Philip Ploska, Michael Oh and 3 more

3 registry-linked trialsAbstract read
In one paragraph

Article in Medical devices (Auckland, N.Z.), 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 30 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed, 1 pooled it
–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.

NCT01640353 completednot on this map

Sacroiliac Joint Fusion With iFuse Implant System (SIFI)

TypeobservationalSponsorSI-BONE, Inc.Ran2012 to 2016Enrolled194ConditionsDegenerative Sacroiliitis, Sacroiliac Joint Disruption
NCT01681004 nacompletednot on this map

INSITE Investigation of Sacroiliac Fusion Treatment

TypeinterventionalSponsorSI-BONE, Inc.Ran2012 to 2017Enrolled159ConditionsDegenerative Sacroiliitis, Sacroiliac Joint DisruptionArmsiFuse Implant System, Non-surgical management
NCT02270203 completednot on this map

LOIS: Long-Term Follow-Up in INSITE/SIFI

TypeobservationalSponsorSI-BONE, Inc.Ran2014 to 2019Enrolled103ConditionsDegenerative Sacroilitis, Sacroiliac Joint DisruptionArmsPelvic CT at 5 years post-op
3 · Its place in the literature

Who cites it

30 citing papers in PubMed, 1 synthesis or guideline pooled it.

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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

13 authors.

Peter G WhangDepartment of Orthopedics and Rehabilitation, Yale University School of Medicine, New Haven, CT, USA.
Emily DarrDepartment of Orthopaedics, Medical University of South Carolina, Charleston, SC, USA.
S Craig MeyerColumbia Orthopaedic Medical Group, Columbia, Mo, USA.
Don KovalskyOrthopaedic Center of Southern Illinois, Mt. Vernon, IL, USA.ORCID 0000-0001-6357-3066
Clay FrankIntegrated Spine Care, Wawautosa, WI, USA.ORCID 0000-0003-4748-0470
Harry LockstadtBluegrass Orthopedics, Lexington, KY, USA.
Robert LimoniBayCare Clinic Orthopedics and Sports Medicine, Green Bay, WI, USA.
Andy J RedmondPrecision Spine Care, Tyler, TX, USA.
Philip PloskaOrthoSpine Solutions, Stockbridge, GA, USA.
Michael OhDepartment of Neurosurgery, Allegheny General Hospital, Pittsburgh, PA, USA.ORCID 0000-0003-0477-6116
Abhineet ChowdharyNeuroscience Institute, Overlake Hospital, Bellevue, WA, USA.
Daniel CherClinical Affairs, SI-BONE, Inc, Santa Clara, CA, USA.ORCID 0000-0002-3747-7879
Travis HillenDepartment of Radiology, Division of Diagnostic Radiology, Musculoskeletal Section, Washington University St. Louis, St. Louis, MO, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAccumulating evidence supports the long-term safety and effectiveness of minimally invasive sacroiliac joint fusion (SIJF) for sacroiliac joint dysfunction.

objectiveTo report 5-year clinical and radiographic follow-up in patients undergoing SIJF using triangular titanium implants (TTI).

methodsOne hundred and three subjects at 12 centers treated with SIJF using TTI in two prospective clinical trials (NCT01640353 and NCT01681004) were enrolled and followed in the current study (NCT02270203) with clinic visits at 3, 4 and 5 years. CT scans performed at 5 years were compared to prior CT scans (at 1 or 2 years) by an independent radiologist.

resultsCompared to baseline scores, SIJ pain scores at 5 years decreased by a mean of 54 points, disability scores (Oswestry Disability Index) decreased by 26 points, and quality of life scores (EuroQOL-5D time trade-off index) increased by 0.29 points (0-1 scale) (all p<0.0001). Satisfaction rates were high and the proportion of subjects taking opioids decreased from 77% at baseline to 41% at 5-year follow-up. Independent radiographic analysis showed a high rate (98%) of bone apposition to implants on both the sacral and iliac sides of the SI joint, with a high rate of bony bridging (87%) and a low rate of radiolucencies suggestive of loosening (5%).

conclusionA 5-year follow-up showed continued excellent clinical responses in patients with SIJ pain treated with SIJF using triangular titanium implants along with a high rate (88%) of joint fusion. LEVEL OF EVIDENCE: Level II.

Indexed as

arthrodesissacroiliac joint degenerationsacroiliac joint fusionsacroiliac joint pain

Identifiers

PMID31576181
PMCPMC6769032

What OpenQuestion holds

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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.