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NCT00943384 · ClinicalTrials.gov registry record · NA

Prospective, Multi-Center Clinical Outcomes Study Evaluating the chronOS Strip Combined With Bone Marrow Aspirate

A NA study, sponsored by Synthes USA HQ.

Completed
Registry status
NA
Development phase
104
Enrollment target

NCT00943384 is a NA study that has completed, run by Synthes USA HQ. The registered enrollment target is 104 participants.

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The verdict

NCT00943384, a NA study, has completed, sponsored by Synthes USA HQ.

COMPLETED
Registry status
NA
Development phase
104 participants
Enrollment target

Study Summary

The chronOS Strip is a synthetic bone void filler manufactured from chronOS beta-tricalcium phosphate (β-TCP) granules and a resorbable polymer \[poly(lactide co-ε-caprolactone)\]. The chronOS Strip, combined with autogenous bone and/or bone marrow or autograft, is intended to be used in the spine for posterolateral fusion. The purpose of this prospective, multi-center clinical case series was to evaluate posterolateral fusion rates in a prospective series of patients with degenerative disc disease. The surgical procedure consisted of instrumented posterolateral fusion with interbody support. The chronOS Strip, combined with bone marrow aspirate and local bone, was applied to the posterolateral gutters.

Interventions

  • DEVICE chronOS Strip

Trial Details

FieldValue
Enrollment Target 104 participants
Start Date 2009-07
Est. Completion 2013-10
Phase NA

Sponsor

Synthes USA HQ

7 total trials

What the Registry Record Tells You About NCT00943384

The ClinicalTrials.gov registry entry for NCT00943384 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 104 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Synthes USA HQ, which has 7 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which chronOS Strip is the first listed.

NCT00943384 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00943384 about?

NCT00943384 is a clinical study titled "Prospective, Multi-Center Clinical Outcomes Study Evaluating the chronOS Strip Combined With Bone Marrow Aspirate". The chronOS Strip is a synthetic bone void filler manufactured from chronOS beta-tricalcium phosphate (β-TCP) granules and a resorbable polymer \[poly(lactide co-ε-caprolactone)\]. The chronOS Strip, combined with autogenous bone and/or bone marrow or autograft, is intended to be used in the spine f...

What is the current status of trial NCT00943384?

This trial is currently completed. It is a NA study. The enrollment target is 104 participants. The study started on 2009-07. Estimated completion is 2013-10.

What interventions are being tested in trial NCT00943384?

The interventions under investigation include: chronOS Strip (DEVICE).

Who is sponsoring clinical trial NCT00943384?

This trial is sponsored by Synthes USA HQ, which has 7 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.