A prospective, multi-center clinical and radiographic outcomes evaluation of ChronOS strip for lumbar spine fusion

Adam S. Kanter, Gurpreet S. Gandhoke, William C. Welch, Paul M. Arnold, Joseph S. Cheng, David O. Okonkwo

Research output: Contribution to journalArticlepeer-review

Abstract

This prospective clinical study evaluated the use of a composite bone void filler (ChronOS Strip, DePuy Synthes, West Chester, PA, USA), combined with bone marrow aspirate plus local autologous bone, in a series of patients undergoing instrumented posterolateral spinal fusion with interbody support. Seventy-six patients were enrolled and treated per protocol at 13 clinical sites. At 24 months, 55/76 patients (72%) were evaluated, with 49/76 (65%) having sufficient data to determine the primary endpoint. The primary endpoint, posterolateral fusion success, was achieved in 48/54 (88.9%) patients at 12 months and in 45/49 (91.8%) patients at 24 months. At all follow-up time points, statistically significant improvements were observed when compared to baseline in back and leg pain and functional status as measured by visual analog scale, Oswestry Disability Index and 12-Item Short Form health surveys. This prospective multi-center series provides evidence that the composite bone void filler, when applied posterolaterally with instrumentation, bone marrow aspirate and/or local autologous bone and concomitant interbody support, can be used to achieve a successful posterolateral fusion, resulting in improvements in clinical outcomes in patients with degenerative disc disease.

Original languageEnglish (US)
Pages (from-to)36-40
Number of pages5
JournalJournal of Clinical Neuroscience
Volume25
DOIs
StatePublished - Mar 1 2016
Externally publishedYes

Keywords

  • Beta-tricalcium phosphates
  • Bone marrow aspirate
  • Posterolateral fusion

ASJC Scopus subject areas

  • Surgery
  • Neurology
  • Clinical Neurology
  • Physiology (medical)

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