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NCT02317185 · ClinicalTrials.gov registry record

Clinical Evaluation of GENEX® DS in Instrumented Posterolateral Fusion

A clinical trial, sponsored by Spine Wave.

Terminated
Registry status
2
Enrollment target

NCT02317185 is a clinical trial that was terminated before completion, run by Spine Wave. The registered enrollment target is 2 participants.

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The verdict

NCT02317185 was terminated before completion, sponsored by Spine Wave.

TERMINATED
Registry status
2 participants
Enrollment target

Study Summary

The overall goal of this clinical study is to characterize the fusion rate of geneX® ds bone graft substitute in comparison to autograft, which is considered the gold standard for posterolateral fusion. Assessments are made using AP and Lateral x-rays, F/E x-rays, and CT scans geneX® ds has been cleared by the FDA for use in these procedures; however this study will allow more detailed characterization of geneX® ds performance in the long-term (1 year). By using the patient as their own control, direct comparison to autograft can be performed while minimizing other variables.

Interventions

  • DEVICE genex bone graft with bone graft
  • OTHER autogenous bone graft

Trial Details

FieldValue
Enrollment Target 2 participants
Start Date 2014-12
Est. Completion 2016-12

Sponsor

Spine Wave

2 total trials

What the Registry Record Tells You About NCT02317185

The ClinicalTrials.gov registry entry for NCT02317185 describes a study currently listed as terminated, categorized as an unspecified phase. The registered enrollment target is 2 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Spine Wave, which has 2 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which genex bone graft with bone graft is the first listed.

NCT02317185 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02317185 about?

NCT02317185 is a clinical study titled "Clinical Evaluation of GENEX® DS in Instrumented Posterolateral Fusion". The overall goal of this clinical study is to characterize the fusion rate of geneX® ds bone graft substitute in comparison to autograft, which is considered the gold standard for posterolateral fusion. Assessments are made using AP and Lateral x-rays, F/E x-rays, and CT scans geneX® ds has been cle...

What is the current status of trial NCT02317185?

This trial is currently terminated. The enrollment target is 2 participants. The study started on 2014-12. Estimated completion is 2016-12.

What interventions are being tested in trial NCT02317185?

The interventions under investigation include: genex bone graft with bone graft (DEVICE), autogenous bone graft (OTHER).

Who is sponsoring clinical trial NCT02317185?

This trial is sponsored by Spine Wave, which has 2 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.