The safety and efficacy of OP-1 (rhBMP-7) as a replacement for iliac crest autograft for posterolateral lumbar arthrodesis: minimum 4-year follow-up of a pilot study

Vaccaro, Alexander R.; Whang, Peter G.; Patel, Tushar; Phillips, Frank M.; Anderson, D. Greg; Albert, Todd J.; Hilibrand, Alan S.; Brower, Richard S.; Kurd, Mark F.; Appannagari, Anoop; Patel, Milan M.; Fischgrund, Jeffrey S.

doi:10.1016/j.spinee.2007.03.012

Cited by 145 publications

(108 citation statements)

References 34 publications

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“…(We do acknowledge use of OP-1 in this manner is off label). Numerous basic and clinical studies have demonstrated the ability of bone morphogenetic protein (BMP) to induce the cellular events leading to the formation of new bone [20][21][22][23][24][25]. BMP-2, BMP-4, and BMP-7 (also known as OP-1) are the principal osteoinductive BMPs.…”

Section: Treatment Of Proximal Tibiofibular Instabilitymentioning

confidence: 99%

Successful Fusion of the Proximal Tibiofibular Joint with Osteogenic Protein-1 (OP-1) Augmentation

2012

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Proximal tibiofibular joint (PTFJ) instability is rare, but when encountered can be difficult to manage. Previously reported forms of treatment, including cast immobilization, soft tissue repairs and reconstructions, and fibular head resection have met with limited success. Another option is PTFJ arthrodesishowever, fusion can be difficult and ankle pain after surgery is not uncommon. In this report, we present a novel surgical technique used to treat PTFJ instability. It is a form of PTFJ arthrodesis that utilizes the osteoinductive agent recombinant human osteogenic protein (rhOP-1) to help achieve fusion, in conjunction with a fibular osteotomy to unload the PTFJ and to preserve normal rotator mobility of the distal fibula during ankle motion. We have used this technique in two patients with successful results; one of whom required revision after two previous failed attempts at PTFJ fusion and the other who had a previous diagnosis of underlying collagen disorder. Their case studies are presented in detail in this report.

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Section: Treatment Of Proximal Tibiofibular Instabilitymentioning

confidence: 99%

Successful Fusion of the Proximal Tibiofibular Joint with Osteogenic Protein-1 (OP-1) Augmentation

2012

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“…For example, in a study of thirty-six patients who underwent instrumented single-level posterolateral fusion, the fusion rate was 63% in the OP-1 group and 67% in the control group 15 . Another study reported that radiographic evidence of a solid fusion was present in only eleven (69%) of sixteen patients in whom OP-1 putty was used 16 . RhBMP-2 (INFUSE; Medtronic, Memphis, Tennessee) was granted premarket approval in 2002 for anterior lumbar interbody spinal fusion in conjunction with threaded fusion cages 17 .…”

Section: Current Status Of Osteoinductive Agents For Spine Fusionmentioning

confidence: 99%

2011 AOA Symposium: Tissue Engineering and Tissue Regeneration

Rodeo

Boden

Murray³

et al. 2013

The Journal of Bone and Joint Surgery-American Volume

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“…However, other authors have studied the safety of BMP as a function of dosage and type. In a RCT, Vaccaro et al assessed the utilization of OP-1 for posterolateral fusion and failed to demonstrate any significant differences in the risks of adverse events (including cancer) between the OP-1 and ICBG groups at the 12, 24, and 48 month follow-ups [30][31][32][33]. Furthermore, Mesfin et al analyzed the relation between the dosage of rhBMP-2 and cancer risk [34•].…”

Section: Cancermentioning

confidence: 99%

Point-counter-point debate: the association between recombinant human bone morphogenetic protein utilization and complications in spine surgery

Siemionow

Sundberg

Tyrakowski³

et al. 2014

Curr Rev Musculoskelet Med

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Bone morphogenetic proteins (BMPs) have been utilized in spine surgery for over 10 years as a bone graft substitute. Potential BMP-related adverse effects including retrograde ejaculation and heterotopic neuroforaminal bone formation have been described. Additionally, some studies have suggested an association between BMP and cancer. Inconsistencies exist in the published spine literature with regards to the incidence and association of complications with BMP utilization. In a point-counterpoint format, this article discusses the current evidence concerning the relationship between the utilization of BMP in spinal fusion and the risk of cancer, retrograde ejaculation (RE), neuroforaminal bone formation, and its role in anterior cervical spine surgery and adolescents.Keywords Bone morphogenetic protein . Retrograde ejaculation . Anterior cervical fusion . Neuroforaminal bone growth . Cancer Point-counterpointRetrograde Ejaculation (RE) RE occurs secondary to impaired function of the internal vesicle sphincter muscle. Anterior lumbar approaches, particularly at the L5-S1 level, carry a greater potential for damage to the superior hypogastric sympathetic plexus, which innervates the internal vesicle sphincter muscle. Other etiologies of RE including diabetes, benign prostate hypertrophy and its treatment, multiple sclerosis, pelvic trauma, and pelvic or rectal surgery [1][2][3][4][5][6]. RE following anterior lumbar spine surgery is also purported to be related to the surgical approach [7][8][9].Burkus et al first published a prospective, randomized, nonblinded FDA-approved study concerning the use of rhBMP-2 in ALIF [8]. Six males (4.1 %; 6/146) reported RE following surgery, of which 4 underwent a transperitoneal approach (TPA) (13.3 %; 4 of all 30 males that underwent TPA) and 2 underwent a retroperitoneal approach (RPA) (1.8 %; 2 of 116 males that underwent RPA). Since the difference in RE between the TPA and RPA groups was statistically significant the authors concluded that a TPA was associated with a higher risk of RE. No comparison in RE between the investigational and control group was performed. The reported differences between the 2 approaches persisted at the 2-year follow-up period [10]. However, in 2010 Smoljanovic et al reviewed the data by Burkus et al [11] and reported that all 6 patients with RE had received rhBMP-2. Thus, the prevalence of RE in the investigational group (rhBMP-2) would have been 7.7 % (6/78 males), which was significantly greater than the control group (ICBG). The reason for ignoring the relationship between RE and rhBMP-2 was questioned, which sparked an intense debate over the potential association between the utilization of rhBMP-2 and RE.Correlation between rhBMP-2 utilization and RE Curr Rev Musculoskelet Med (2014) 7:200-207 DOI 10.1007/s12178-014-9219-x patients (7.2 %) in the rhBMP-2 group developed RE while only 1 of 174 patients (0.6 %; 1/69) reported RE in the control group. Significant differences in RE were also evident among patients that underwent a singl...

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The safety and efficacy of OP-1 (rhBMP-7) as a replacement for iliac crest autograft for posterolateral lumbar arthrodesis: minimum 4-year follow-up of a pilot study

Cited by 145 publications

References 34 publications

Successful Fusion of the Proximal Tibiofibular Joint with Osteogenic Protein-1 (OP-1) Augmentation

Successful Fusion of the Proximal Tibiofibular Joint with Osteogenic Protein-1 (OP-1) Augmentation

2011 AOA Symposium: Tissue Engineering and Tissue Regeneration

Point-counter-point debate: the association between recombinant human bone morphogenetic protein utilization and complications in spine surgery

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