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In a 32-year-old male with an acute, open tibial shaft fracture treated with minimally-invasive locked plating 8 days from the initial injury
28%
1005/3568
In the lumbar spine in a 45-year-old female undergoing posterior decompression and instrumented posterolateral fusion from L4 to S1
14%
512/3568
In the cervical spine in a 56-year-old female undergoing anterior cervical discectomy and fusion of C5-C6
3%
121/3568
In the lumbar spine in a 52-year-old male undergoing L5-S1 anterior lumbar interbody fusion for degenerative disc disease and spinal stenosis
49%
1735/3568
In the cervical spine in a 60-year-old male undergoing posterior decompression and posterior instrumented fusion of C3-C7
5%
163/3568
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rhBMP-2 is FDA approved for use together with the lumbar tapered fusion device (LT Cage; Medtronic) in single-level ALIF from L2 to S1 levels in degenerative disc disease. rhBMP-2 is also FDA approved for use in open tibial shaft fractures stabilized with an IM nail and treated within 14 days of initial injury. rhBMP-7 has received FDA humanitarian device exemption approval as an alternative to autograft in recalcitrant long bone nonunions where use of autograft is unfeasible and alternative treatments have failed. It is also approved as an alternative to autograft in compromised patients (with osteoporosis, smoking or diabetes) requiring revision posterolateral/intertransverse lumbar fusion for whom autologous bone and bone marrow harvest are not feasible or are not expected to promote fusion. Epstein reviewed the indications for rhBMP-2 use and its off-label use. She found that anterior cervical surgery with BMP2 led to dysphagia and airway complications. With posterior lumbar spine surgery, complications included vertebral osteolysis (bone resorption) and ectopic bone formation/heterotopic ossifications, which made revision surgery difficult. Burkus et al. prospectively compared 46 patients undergoing single-level ALIF with BMP-2 vs with autograft in an industry sponsored study. They found that patients receiving BMP-2 had higher rates of fusion and improvement in pain and neurologic status at 12 and 24 months compared with autograft, and there were no adverse events. They recommend rhBMP-2 in ALIF procedures to eliminate pain and scarring from iliac crest bone harvest. Illustration A shows the FDA approved combination of INFUSE (rhBMP-2) and LT-CAGE device. Incorrect Answers: Answer 1: rhBMP-2 is approved for open tibial shaft fractures stabilized with an IM nail and treated within 14 days of the initial injury. It is not approved for use with plates and screws. Answer 2: rhBMP-2 is not approved for posterior lumbar spine surgery. It is not approved for more than 1 spinal level. Answers 3 and 5: rhBMP-2 is not approved for cervical spine surgery.
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