Authors' recommendations: In the United States, more than 325,000 spinal fusions (mostly autografts) were performed in 2003 (National Center for Health Statistics 2003). Considering the autograft failure rate of 5% to 40% (Vaccaro et al. 2002), approximately 16,250 to 130,000 patients will require some form of additional treatment to overcome their symptoms. A proportion of these patients are likely to require revision spinal surgery.Statistical data for spinal fusion in Australia was not available at the time of writing; however, according to Walker et al. (2004) 79% of Australian adults suffer from lower back pain at some point of their life.OP-1 Putty, if proven effective, could result in substantial improvements to the well-being of individuals requiring spinal fusion. Patients would not be subjected to the complications related to iliac crest bone harvest such as persistent donor site pain which occurs in 25% of patients (Boden 2005). In addition to this, OP-1 Putty may have the potential to increase fusion rates and perhaps even more so when used in conjunction with existing techniques.Due to the fact that OP-1 Putty contains a bovine collagen base, it is unlikely to be introduced in Australia given the current stance of the Therapeutic Goods Administration towards bovine derived products. However, OP-1 in the 'non-putty' form has been approved for use in Australia since April 2001. The discovery of OP-1 antibodies and neutralising antibodies in patients treated with OP-1 Putty is a potential point of concern and surgeons currently utilizing the non-putty form of OP-1 should be aware of the potential complications that may arise due to this. More robust evidence stemming from the randomized controlled trial in the United States will be useful in determining any risks that may be associated with the immunogenic response towards OP-1.

Project Status: Completed

URL for project: http://www.horizonscanning.gov.au/internet/horizon/publishing.nsf/Content/211ABF81A69CA39DCA2575AD0080F3DC/$File/HS%20OP1%20Putty.pdf

Year Published: 2006

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Australia

Organisation Name: Australian Safety and Efficacy Register of New Interventional Procedures-Surgical

Contact Address: ASERNIP-S 24 King William Street, Kent Town SA 5067 Australia Tel: +61 8 8219 0900

Contact Name: racs.asernip@surgeons.org

Contact Email: racs.asernip@surgeons.org

Copyright: Australian Safety and Efficacy Register of New Interventional Procedures - Surgical (ASERNIP-S)