CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 104 enrolled
Drug / intervention
chronOS Stripdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00943384
NCT00943384N/ACompleted

Prospective, Multi-Center Clinical Outcomes Study Evaluating the chronOS Strip Combined With Bone Marrow Aspirate Plus Local Bone for Posterolateral Lumbar Interbody Fusion or Lumbosacral Interbody Fusion

Synthes USA HQ, Inc.·interventional·Posted Jul 22, 2009·Updated Nov 26, 2014

In Brief

A clinical study evaluating chronOS Strip for Degeneration of Lumbar Intervertebral Disc. Completed, enrolled 104 participants across 13 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJul 22, 2009
Enrollment StartJul 1, 2009
Primary CompletionOct 1, 2013
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 16.9 years ago

Interventions

chronOS Stripdevice

chronOS strip combined with bone marrow aspirate plus local bone