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

Degeneration of Lumbar Intervertebral Disc Clinical Trial

Official title: 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

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Degeneration of Lumbar Intervertebral Disc
• Intervertebral Disc Degeneration

• NCT number: NCT00943384
• Study type: Interventional
• Source: Synthes USA HQ, Inc.
• Status: Completed
• Phase: N/A
• Start date: July 2009
• Completion date: October 2013