Evidence map›Paper›PMID 36964582›Full record

Trial reportJournal of orthopaedic surgery and research2023

12-Month clinical and radiographic outcomes of ViBone viable bone matrix in patients undergoing cervical and lumbar spinal fusion surgery.

Paul D Kim, Ramin Raiszadeh, David A Bomback, David L Kramer, Michael Moghimi

Registry-linked trialOpen access · goldFull text readClinical Trial
In one paragraph

Trial report in Journal of orthopaedic surgery and research, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03425682 (A Prospective, Post-Market, Multi-Center Study Evaluating ViBone® in Cervical and Lumbar Spine Fusion), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.5field-weighted citation impact, top 33% 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.

NCT03425682 completednot on this map

A Prospective, Post-Market, Multi-Center Study Evaluating ViBone® in Cervical and Lumbar Spine Fusion

TypeobservationalSponsorElutia Inc.Ran2018 to 2021Enrolled118ConditionsSpondylosis, Cervical Spondylosis, Spondylolisthesis, Herniated Nucleus PulposusArmsViBone
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 2 citations in OpenAlex.

  1. Review
  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

5 authors at 3 institutions in 1 country.

Paul D KimSpine Institute of San Diego, 6719 Alvarado Road Suite 308, San Diego, CA, 92120, USA. paul@siosd.com.ORCID http://orcid.org/0000-0002-1544-2309
Ramin RaiszadehSpine Institute of San Diego, 6719 Alvarado Road Suite 308, San Diego, CA, 92120, USA.ORCID http://orcid.org/0000-0001-9943-106X
David A BombackConnecticut Neck and Back Specialists, 39 Hospital Ave, Danbury, CT, 06810, USA.
David L KramerConnecticut Neck and Back Specialists, 39 Hospital Ave, Danbury, CT, 06810, USA.
Michael MoghimiOrthopaedic Specialists of Austin, 4611 Guadalupe Street Suite 200, Austin, TX, 78751, USA.
Danbury Hospital · USSan Diego Spine Institute · USNorthwest Orthopaedic Specialists · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTo investigate the clinical safety and efficacy of ViBone

methodsThis was a multi-center, prospective, post-market study evaluating the safety and efficacy of ViBone VBM in patients undergoing 1-3 level anterior cervical discectomy and fusion or lumbar interbody fusion surgery. Patients were evaluated at baseline, 6-month, and 12-month follow-up clinically and radiographically. Clinical assessment included Visual Analog Scale for pain (VAS-pain), the Neck Disability Index (NDI) for patients with cervical pathologies, and the Oswestry Disability Index (ODI) for patients with lumbar pathologies. Fusion success defined by an independent radiologist was determined radiographically by plain films.

resultsClinical outcomes evaluated with VAS-pain, NDI, and ODI scales were improved significantly at 6 and 12 months compared to baseline. All patients reached clinically significant improvements at 12 months. There were no adverse events or infections attributed to ViBone VBM. At 12 months, the fusion rate per patient was 88.1% in cervical and 97.6% in lumbar patients, while per-level fusion was 98.5% for cervical and 100% for lumbar segments.

conclusionsPatients undergoing cervical and lumbar spinal fusion implanted with ViBone VBM demonstrated favorable outcomes at 6 months and 12 months as measured by subjective clinical measures and radiographic fusion rates. Trial registration This study was registered as NCT03425682 on 1/29/2018.

Indexed as

Spinal FusionBone MatrixHumansLumbar VertebraePainProspective StudiesTreatment OutcomeBone allograftCervical spineLumbar spineSpine fusionViable bone matrix

Identifiers

PMID36964582
PMCPMC10039495
OpenAlexW4360939538

What OpenQuestion holds

Textfull text, public
LicenceCC BY
measurements read218
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.