Evidence map›Paper›PMID 27233773›Full record

ArticleJournal of orthopaedic surgery and research2016

Clinical evaluation of an allogeneic bone matrix containing viable osteogenic cells in patients undergoing one- and two-level posterolateral lumbar arthrodesis with decompressive laminectomy.

David B Musante, Michael E Firtha, Brent L Atkinson, Rebekah Hahn, James T Ryaby, Raymond J Linovitz

Open access · goldAbstract read
In one paragraph

Article in Journal of orthopaedic surgery and research, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
1.2field-weighted citation impact, top 21% 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.

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

12 citing papers in PubMed, 22 citations in OpenAlex.

  1. Review
  2. Radiographic Fusion Outcomes for Trinity Cellular Based Allograft versus Local Bone in Posterolateral Lumbar Fusion.Journal of the American Academy of Orthopaedic Surgeons. Global research & reviews · 2024
    Article
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  6. Review
  7. Allografts and Spinal Fusion.International journal of spine surgery · 2021
    Article
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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

6 authors at 4 institutions in 1 country.

David B MusanteTriangle Orthopedics, 120 William Penn Plaza, Durham, NC, 27704, USA. dmusante@triangleortho.com.
Michael E FirthaCampbell School of Osteopathic Medicine, Campbell University, 4350 US-421, Lillington, NC, 27546, USA.
Brent L AtkinsonAtkinson Biologics Consulting, 9189 Fox Fire Way, Highlands Ranch, Littleton, CO, 80129, USA.
Rebekah HahnOrthofix Inc., 3451 Plano Parkway, Lewisville, TX, 75056, USA.
James T RyabyOrthofix Inc., 3451 Plano Parkway, Lewisville, TX, 75056, USA.
Raymond J LinovitzOrthofix Inc., 3451 Plano Parkway, Lewisville, TX, 75056, USA.
Orthofix (United States) · USAdvanced Emissions Solutions (United States) · USCampbell University · USTriangle · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTrinity Evolution® cellular bone allograft (TE) possesses the osteogenic, osteoinductive, and osteoconductive elements essential for bone healing. The purpose of this study is to evaluate the radiographic and clinical outcomes when TE is used as a graft extender in combination with locally derived bone in one- and two-level instrumented lumbar posterolateral arthrodeses.

methodsIn this retrospective evaluation, a consecutive series of subject charts that had posterolateral arthrodesis with TE and a 12-month radiographic follow-up were evaluated. All subjects were diagnosed with degenerative disc disease, radiculopathy, stenosis, and decreased disc height. At 2 weeks and at 3 and 12 months, plain radiographs were performed and the subject's back and leg pain (VAS) was recorded. An evaluation of fusion status was performed at 12 months.

resultsThe population consisted of 43 subjects and 47 arthrodeses. At 12 months, a fusion rate of 90.7 % of subjects and 89.4 % of surgical levels was observed. High-risk subjects (e.g., diabetes, tobacco use, etc.) had fusion rates comparable to normal patients. Compared with the preoperative leg or back pain level, the postoperative pain levels were significantly (p < 0.0001) improved at every time point. There were no adverse events attributable to TE.

conclusionsFusion rates using TE were higher than or comparable to fusion rates with autologous iliac crest bone graft that have been reported in the recent literature for posterolateral fusion procedures, and TE fusion rates were not adversely affected by several high-risk patient factors. The positive results provide confidence that TE can safely replace autologous iliac crest bone graft when used as a bone graft extender in combination with locally derived bone in the setting of posterolateral lumbar arthrodesis in patients with or without risk factors for compromised bone healing.

trial registrationBecause of the retrospective nature of this study, the trial was not registered.

Indexed as

OsteogenesisAdultAgedAged, 80 and overBone MatrixBone TransplantationCell SurvivalDecompression, SurgicalFemaleFollow-Up StudiesHumansLaminectomyLumbar VertebraeMaleMiddle AgedPain MeasurementBone graft extenderCellular bone allograftLumbar spine fusionSpinal arthrodesisTrinity Evolution

Identifiers

PMID27233773
PMCPMC4884431
OpenAlexW2395756734

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.