RhBMP-2 use in lumbar fusion surgery is associated with transient immediate post-operative leg pain

Department of Orthopaedics and Spinal Surgery, Mater Private Hospital, 69 Eccles St, Dublin 7, Ireland.
European Spine Journal (Impact Factor: 2.07). 12/2011; 21(7):1331-7. DOI: 10.1007/s00586-011-2113-y
Source: PubMed


Supra-physiological rhBMP loads during spinal fusion may trigger local inflammation and post-operative radiculitis. MRI is an effective tool to detect nerve root compression in severe post-operative leg pain. The aim of this study was to determine if recombinant bone morphogenic protein 2 (rhBMP-2) is associated with immediate post-operative leg pain without evidence of root compression using MRI.
All patients undergoing posterolateral and posterior interbody lumbar spinal fusions with rhBMP-2 between July 2007 and January 2009 at a single surgeon practice were retrospectively reviewed for incidence of severe immediate post-operative leg pain. Patients that presented with immediate post-operative leg pain were interviewed and Oswestry Disability Indices calculated.
Sixty-four rhBMP-2 treated patients and 40 controls were included. Pre-operative demographics and diagnoses were similar and inter-body cages were used equally. Immediate post-operative leg pain incidence was 25 and 12.5% in the rhBMP-2 and non-rhBMP-2 groups, respectively. 17.2% of the patients treated with rhBMP-2 had immediate post-operative leg pain without evidence of nerve root compression on MRI versus 7.5% of the patients treated without rhBMP-2. At follow-up, leg pain incidence was 11.6 and 7.6% in rhBMP-2 and non-rhBMP-2 groups, respectively. There was no difference in Oswestry Disability Indices between groups (36.5 ± 31.2 vs. 23.0 ± 25.5).
RhBMP-2 associated radiculitis presenting as immediate post-operative leg pain without MRI evidence of neuronal compression occurs in 17% of the patients with rhBMP-2 assisted fusion. Patients should be pre-operatively counselled regarding immediate post-operative leg pain with rhBMP-2.

19 Reads
  • [Show abstract] [Hide abstract]
    ABSTRACT: Spine fusion is considered to be the gold standard for the treatment of most degenerative and traumatic spinal conditions. Bone graft is still the best choice to achieve fusion and currently autologous and allograft bone are the main sources for bone grafting procedures. Autologous bone has by far the most osteogenic potential, but it is limited and it can lead to a donor site pain condition. Allograft bone is an important source when structural or large volumes of grafts are required. Concerns related to the use of both autografts and allografts has led to the search for alternatives, but synthetic bone graft substitutes as yet offer only a partial solution to the management of localized bone loss. They possess some of the desired mechanical qualities of bone as well as osteointegrative/conductive properties, but are largely reliant on viable periosteum/bone for their success. The advent of composite synthetic bone graft substitutes and biologically active factors is moving closer to the goal of obtaining a synthetic bone graft substitute that mimics the native bone in both mechanical and osteogenic properties.
    No preview · Article · Dec 2012 · Archivio di Ortopedia e Reumatologia
  • [Show abstract] [Hide abstract]
    ABSTRACT: Recombinant human bone morphogenetic protein-2 (rhBMP-2) is used as a bone graft substitute in spinal fusion, which unites (fuses) bones in the spine. The accuracy and completeness of journal publications of industry-sponsored trials on the effectiveness and harms of rhBMP-2 has been called into question. To independently assess the effectiveness and harms of rhBMP-2 in spinal fusion and reporting bias in industry-sponsored journal publications. Individual-patient data (IPD) from 17 industry-sponsored studies; related internal documents; and searches of MEDLINE (1996 to August 2012), other databases, and reference lists. Randomized, controlled trials (RCTs) and cohort studies of rhBMP-2 versus any control and uncontrolled studies of harms. Effectiveness outcomes in IPD were recalculated using consistent definitions. Study characteristics and results were abstracted by 1 investigator and confirmed by another. Two investigators independently assessed quality using predefined criteria. Thirteen RCTs and 31 cohort studies were included. For lumbar spine fusion, rhBMP-2 and iliac crest bone graft were similar in overall success, fusion, and other effectiveness measures and in risk for any adverse event, although rates were high across interventions (77% to 93% at 24 months from surgery). For anterior lumbar interbody fusion, rhBMP-2 was associated with nonsignificantly increased risk for retrograde ejaculation and urogenital problems. For anterior cervical spine fusion, rhBMP-2 was associated with increased risk for wound complications and dysphagia. At 24 months, the cancer risk was increased with rhBMP-2 (risk ratio, 3.45 [95% CI, 1.98 to 6.00]), but event rates were low and cancer was heterogeneous. Early journal publications misrepresented the effectiveness and harms through selective reporting, duplicate publication, and underreporting. Outcome assessment was not blinded, and ascertainment of harms in trials was poor. No trials were truly independent of industry sponsorship. In spinal fusion, rhBMP-2 has no proven clinical advantage over bone graft and may be associated with important harms, making it difficult to identify clear indications for rhBMP-2. Earlier disclosure of all relevant data would have better informed clinicians and the public than the initial published trial reports did. Yale University and Medtronic.
    No preview · Article · Jun 2013 · Annals of internal medicine
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: Anterior lumbar interbody fusion (ALIF) is an established treatment for structural instability associated with symptomatic disk degeneration (SDD). Stand-alone ALIF offers many advantages, however, it may increase the risk of non-union. Recombinant human bone morphogenetic protein-2 (BMP-2) may enhance fusion rate but is associated with postoperative complication. The optimal dose of BMP-2 remains unclear. This study assessed the fusion and subsidence rates of stand-alone ALIF using the SynFix-LR interbody cage with 6 ml/level of BMP-2. Thirty-two ALIF procedures were performed by a single surgeon in 25 patients. Twenty-five procedures were performed for SDD without spondylolisthesis (SDD group) and seven procedures were performed for SDD with grade-I olisthesis (SDD-olisthesis group). Patients were followed-up for a mean of 17 ± 6 months. Solid fusion was achieved in 29 cases (90.6 %) within 6 months postoperatively. Five cases of implant subsidence were observed (16 %). Four of these occurred in the SDD-olisthesis group and one occurred in the SDD group (57 % vs. 4 % respectively; p = 0.004). Three cases of subsidence failed to fuse and required revision. The body mass index of patients with olisthesis who developed subsidence was higher than those who did not develop subsidence (29 ± 2.6 vs. 22 ± 6.5 respectively; p = 0.04). No BMP-2 related complications occurred. The overall fusion rate of stand-alone ALIF using the SynFix-LR system with BMP-2 was 90.6 %, comparable with other published series. No BMP-2 related complication occurred at a dose of 6 mg/level. Degenerative spondylolisthesis and obesity seemed to increase the rate of implant subsidence, and thus we believe that adding posterior fusion for these cases should be considered.
    Full-text · Article · Aug 2013 · European Spine Journal
Show more