Clinical outcomes and fusion success associated with the use of BoneSave in spinal surgery

Arch Orthop Trauma Surg. 2010 May;130(5):641-7. doi: 10.1007/s00402-009-0936-3. Epub 2009 Jul 23.

Abstract

Background: Achieving spinal fusion is the guiding principle behind surgical treatment for a range of spinal pathologies, often requiring a substantial amount of bone-graft. Iliac crest autograft represents the gold standard although associated morbidities and limited graft material have led to the development of alternatives. BoneSave (Stryker, UK), a porous tricalcium phosphate-hydroxyapatite ceramic, is one such alternative, employed in spinal fusion over the past few years. Very little research exists into the clinical outcomes associated with its use.

Methods: Clinical data was collected retrospectively from the case notes of 45 patients who underwent posterolateral inter-transverse spinal fusion involving the application of BoneSave between June 2003 and January 2005. Latest follow-up information was collected via a postal questionnaire (average follow-up of 46 months). Validated outcome instruments employed included the Short Form 36 and Oswestry Disability Index. In addition visual analogue scales for pain, patient global impression of change, work status, persisting symptoms and patient satisfaction data were collected. Radiological evaluation of fusion was carried out from the most recent spinal radiographs available for each patient.

Results: Qualitative post-operative data was available in 96%, with a questionnaire response rate of 68.4%. Radiographical evaluation was possible in 67%. Significant post-operative improvements were seen across all outcome measures in the large majority of cases. Successful fusion was achieved in 56.7% of cases.

Conclusions: The clinical outcomes associated with the use of BoneSave in spinal fusion are comparable to those available in the literature for more conventional techniques. The fusion rate was not significantly lower.

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Ceramics*
  • Durapatite
  • Female
  • Humans
  • Male
  • Middle Aged
  • Pain Measurement
  • Patient Satisfaction
  • Retrospective Studies
  • Spinal Fusion / instrumentation*
  • Spinal Fusion / methods
  • Surveys and Questionnaires
  • Treatment Outcome

Substances

  • Durapatite