Symptomatic ectopic bone formation after off-label use of recombinant human bone morphogenetic protein-2 in transforaminal lumbar interbody fusion. Chen NF, Smith ZA, Stiner E, Armin S, Sheikh H, Khoo LT. J Neurosurg Spine 2010;12(1):40–6

2011 ◽  
Vol 11 (1) ◽  
pp. 87-87
2010 ◽  
Vol 12 (1) ◽  
pp. 40-46 ◽  
Author(s):  
Nan-Fu Chen ◽  
Zachary A. Smith ◽  
Eric Stiner ◽  
Sean Armin ◽  
Hormoz Sheikh ◽  
...  

Object Recombinant human bone morphogenetic protein-2 (rhBMP-2) has been approved for use in the lumbar spine in conjunction with the lumbar tapered cage. However, off-label use of this osteoinductive agent is observed with anterior fusion applications as well as with both posterior lumbar interbody fusion and transforaminal lumbar interbody fusion (TLIF). Complications using rhBMP-2 in the cervical spine have been reported. Although radiographic evidence of ectopic bone in the lumbar spine has been described following rhBMP-2 use, this finding was not previously believed to be of clinical relevance. Methods This study was a retrospective review of 4 patients who underwent minimally invasive spinal TLIF (MIS-TLIF) in which bone fusion was augmented with rhBMP-2 applied to an absorbable collagen sponge. Case presentations, operative findings, imaging data, and follow-up findings were reviewed. Results Four cases with delayed symptomatic neural compression following the off-label use of rhBMP-2 with MIS-TLIF were identified. Conclusions Although previously believed to be only a radiographic finding, the development of ectopic bone following rhBMP-2 use in lumbar fusion can be clinically significant. This paper describes 4 cases of delayed neural compression following MIS-TLIF. The reader should be aware of this potential complication following the off-label use of rhBMP-2 in the lumbar spine.


2019 ◽  
Vol 10 (3) ◽  
pp. 280-285
Author(s):  
Shuo Niu ◽  
Albert T. Anastasio ◽  
Razan R. Faraj ◽  
John M. Rhee

Study Design: Retrospective cohort study. Objectives: Reported incidences and complications of heterotopic ossification (HO) after using recombinant human bone morphogenetic protein–2 (rhBMP-2) in transforaminal lumbar interbody fusion (TLIF) have been inconclusive. This study was designed to evaluate both incidences of radiologic and symptomatic HO in a large series of TLIFs using rhBMP-2. Methods: A total of 996 disc levels in 927 consecutive TLIF patients were retrospectively evaluated at 6-month postoperative follow-up in a single surgical practice. Subjects were separated into the BMP group and the control group. Operative reports, pre- and postoperative medical records were reviewed. Computed tomography (CT) scans were analyzed and graded independently for ossification at each disc level of TLIF. Results: A total of 933 disc levels were in the BMP group, and 63 were in the control group. Six-month fusion rate of interbody was 92.5% in the BMP group, which was significantly higher in contrast to 71.4% in the control group ( P < .001). The incidence of radiologic HO in the BMP group was 13.5%, which was significantly higher than 1.6% in the control group ( P = .006). After controlling for basic demographics and comorbidities, the presence of radiologic HO was significantly associated with the use of rhBMP-2 ( P = .026). However, only one case in the BMP group (0.11%) developed a symptomatic HO (mild-medium left buttock pain, treated nonsurgically) involving left foramen of L5-S1. Conclusions: rhBMP-2 can be safely used in TLIF with regard to HO. There was a low rate of radiologic HO and minimal symptomatic HO, with high fusion rates at 6 months postoperative.


2005 ◽  
Vol 3 (6) ◽  
pp. 436-443 ◽  
Author(s):  
Alan T. Villavicencio ◽  
Sigita Burneikiene ◽  
E. Lee Nelson ◽  
Ketan R. Bulsara ◽  
Mark Favors ◽  
...  

Object. Recombinant human bone morphogenetic protein—2 (rhBMP-2) is being increasingly used for spinal fusion. There are few data regarding its clinical safety, effectiveness, and clinical outcome when applied on an absorbable collagen sponge (ACS) in conjunction with allograft for transforaminal lumbar interbody fusion (TLIF). Methods. Seventy-four consecutive patients undergoing TLIF for degenerative disc disease were divided into five groups depending on whether the patient underwent a minimally invasive or open approach, as well as the number of spinal levels surgically treated. Surgery-related data, fusion results, complications, and clinical outcome were evaluated. The mean follow-up duration was 20.6 months (range 14–28 months). The radiographic fusion rate was 100% at 12 and 24 months after the surgery. No bone overgrowth or other complications related to BMP use were demonstrated. Conclusions. Analysis of the results demonstrated that TLIF combined with a BMP-2—soaked ACS is a feasible, effective, and safe method to promote lumbar fusion. There were no significant intergroup differences in clinical outcome between patients who underwent open compared with minimally invasive procedures. Patient satisfaction rates, however, were higher in the minimally invasive procedure group. The efficacy of BMP-2 was not dependent on which approach was used or the number of spinal levels that were treated.


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