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SAFETY OF BMP-7 IN ANTERIOR CERVICAL FUSION SURGERY



Abstract

Purpose of the study: To determine the safety of the use of bone morphogenetic protein-7 (BMP-7) in anterior cervical surgery

Methods and results: A prospective consecutive cohort of 132 patients underwent anterior cervical discectomy and fusion using interbody cages. In 123 of these patients BMP-7 was also used. The dose of BMP-7 was controlled (one half to one unit; 1.75–3.5 mg BMP-7 & 0.5–1.0 gm collagen) and contained (no BMP-7 was placed outside the cage).

The primary outcome measure was the presence of clinical adverse events during the first 30 days. The secondary outcome was the extent of radiological soft tissue swelling at the C6 level as measured on plain radiographs in the early post-operative period and compared to a historical post-operative anterior cervical fusion cohort.

There was no mortality and no re-operation in this series. 2.4% of patients experienced complications: transient brachalgia (1/123), persistent dysphagia (1/123), sudden dysphagia and dysphonia (1/123).

Mean pre-vertebral soft-tissue measurement in 20 patients from the BMP-7 group was 20.9 mm (16–27 mm). This compared with 18.7 mm (15–25 mm) in 7 patients from the non-BMP-7 group, and 18 mm in the historical control group.

Conclusions: BMP-7 can be used safely in anterior cervical fusion surgery. A slight increase in post-operative pre-vertebral swelling was not clinically significant. The effect of BMP-7 on the rate and timing of fusion, as well as clinical outcome, is yet to be elucidated.

Ethics approval: None-audit

Interest Statement: None

Correspondence should be addressed to BASS/BCSS c/o BOA, at the Royal College of Surgeons, 35–43 Lincoln’s Inn Fields, London, WC2A 3PE, England.