Complications in the Use of rhBMP-2 in PEEK Cages for Interbody Spinal Fusions

Vaidya, Rahul; Sethi, Anil; Bartol, Stephen; Jacobson, Mark; Coe, Chad; Craig, Joseph G.

doi:10.1097/bsd.0b013e31815ea897

Cited by 181 publications

(111 citation statements)

References 25 publications

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“…Several factors are reported to cause cage subsidence in intervertebral fusions including LIF: reduced bone quality 12,13) , older age 13) , multilevel procedures 1,14) , narrow cage 1,2) , and use of rhBMP-2 15) . However, the abovementioned reports mixed two types of cage subsidence (intraoperative injury and postoperative spontaneous settling).…”

Section: Discussionmentioning

confidence: 99%

Cage subsidence in lateral interbody fusion with transpsoas approach: intraoperative endplate injury or late-onset settling

Satake

Kanemura

Nakashima

et al. 2017

Spine Surg Relat Res

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Abstract:Introduction: Few studies have investigated the influence of cage subsidence patterns (intraoperative endplate injury or late-onset cage settling) on bony fusion and clinical outcomes in lateral interbody fusion (LIF). This retrospective study was performed to compare the fusion rate and clinical outcomes of cage subsidence patterns in LIF at one year after surgery.Methods: Participants included 93 patients (aged 69.0±0.8 years; 184 segments) who underwent LIF with bilateral pedicle screw fixation. All segments were evaluated by computed tomography and classified into three groups: Segment E (intraoperative endplate injury, identified immediately postoperatively); Segment S (late-onset settling, identified at 3 months or later); or Segment N (no subsidence). We compared patient characteristics, surgical parameters and fusion status at 1 year for the three subsidence groups. Patients were classified into four groups: Group E (at least one Segment E), Group S (at least one Segment S), Group ES (both Segments E and S), or Group N (Segment N alone). Visual analog scales (VASs) and the Japanese Orthopedic Association Back Pain Evaluation Questionnaire (JOABPEQ) were compared for the four patient groups.Results: 184 segments were classified: 31 as Segment E (16.8%), 21 as Segment S (11.4%), and 132 as Segment N (71.7%). Segment E demonstrated significantly lower bone mineral density (-1.7 SD of T-score, p=0.003). Segment S demonstrated a significantly higher rate of polyetheretherketone (PEEK) cages (100%, p=0.03) and a significantly lower fusion rate (23.8%, p=0.01). There were no significant differences in VAS or in any of the JOABPEQ domains among the four patient groups.Conclusions: Intraoperative endplate injury was significantly related to bone quality, and late-onset settling was related to PEEK cages. Late-onset settling demonstrated a worse fusion rate. However, there were no significant differences in clinical outcomes among the subsidence patterns.

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Section: Discussionmentioning

confidence: 99%

Cage subsidence in lateral interbody fusion with transpsoas approach: intraoperative endplate injury or late-onset settling

Satake

Kanemura

Nakashima

et al. 2017

Spine Surg Relat Res

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“…However, followup clinical studies have documented problems with each of these approaches, including postoperative pain, a localized inflammatory response, and variable osteoinductivity. 9,13,18 Consequently, a cost-effective, efficacious bone graft option that can be used universally in spine surgery without these complications has yet to be identified.…”

Section: Discussionmentioning

confidence: 99%

“…Since clinical data demonstrate a host response to rhBMP-2 after implantation, 13,14,17,27,28 four animals in the TrioMatrix 1 and rhBMP-2 groups underwent a modification of the posterolateral arthrodesis protocol followed by magnetic resonance imaging (MRI) evaluation of the lumbar spine to assess localized host response during the bone healing process at the 7-day time point. 29 In addition to arthrodesis, 1.06 AE 0.17 cc 3 of paraspinal muscle compartment was excised bilaterally to create an adjacent space next to the site of fusion.…”

Section: Magnetic Resonance Imagingmentioning

confidence: 99%

“…[10][11][12] In the lumbar spine, reports have demonstrated radiculitis, pseudarthrosis, seroma/hematoma formation, and heterotopic ossification with rhBMP-2 use. [13][14][15][16][17] DBMs, which are derived from human cadaveric bone through an acid extraction process, 18 have been associated with a widely variable osteoinductive potency in vivo. [18][19][20][21][22] Ceramic carriers have shown promise in their clinical use as bone graft extenders, 23 but when used alone, provide no exogenous osteoinductivity.…”

mentioning

confidence: 99%

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Nanocomposite therapy as a more efficacious and less inflammatory alternative to bone morphogenetic protein‐2 in a rodent arthrodesis model

Hsu¹,

Polavarapu²,

Riaz³

et al. 2011

Journal Orthopaedic Research

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The use of recombinant human bone morphogenetic protein-2 (rhBMP-2) in spine fusion has led to concerns regarding a potential accompanying inflammatory response. This study evaluates a combination therapy (TrioMatrix 1 ; Pioneer Surgical, Inc., Marquette, MI) comprised of a demineralized bone matrix (DBM), hydroxyapatite, and a nanofiber-based collagen scaffold in a rodent spine fusion model. Thirty-six athymic rats that underwent a posterolateral intertransverse spinal fusion were randomly assigned to 1 of 5 treatment groups: absorbable collagen sponge alone (ACS, negative control), 10 mg rhBMP-2 on ACS (positive control), TrioMatrix 1 , Grafton 1 (Osteotech, Inc., Eatontown, NJ), and DBX 1 (Synthes, Inc., West Chester, PA). Both TrioMatrix 1 and rhBMP-2-treated animals demonstrated 100% fusion rates as graded by manual palpation scores 8 weeks after implantation. This rate was significantly greater than those of the ACS, Grafton 1 , and DBX 1 groups. Notably, the use of TrioMatrix 1 as evaluated by microCT quantification led to a greater fusion mass volume when compared to all other groups, including the rhBMP-2 group. T2-weighted axial MRI images of the fusion bed demonstrated a significant host response associated with a large fluid collection with the use of rhBMP-2; this response was significantly reduced with the use of TrioMatrix 1 . Our results therefore demonstrate that a nanocomposite therapy represents a promising, cost-effective bone graft substitute that could be useful in spine fusions where BMP-2 is contraindicated.

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“…Recombinant human bone morphogenetic protein-2 (rhBMP-2) in combination with an absorbable collagen sponge (ACS) requires a supraphysiologic dose that carries potential complications, including bone resorption, graft migration, hematoma formation, radiculitis, and heterotopic ossification. [5][6][7][8][9][10][11] Other growth factors, such as platelet-rich plasma, have shown a limited efficacy in promoting healing. 12 While some preclinical studies have investigated the potential of allogeneic mesenchymal stem cell (MSC) therapy, efficacy concerns have thus far prevented its introduction into clinical practice.…”

mentioning

confidence: 99%

A Comparative Evaluation of Factors Influencing Osteoinductivity Among Scaffolds Designed for Bone Regeneration

Hsu

Ghodasra

Ashtekar

et al. 2013

Tissue Engineering Part A

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Due to differing compositions, synthetic scaffolds developed for bone regeneration vary widely in efficacy. To quantify the impact of such differences on osteoinductivity, numerous parameters were examined. Absorbable collagen sponge (ACS), three ceramic-based carriers (#1-3) of varying compositions, mineralized allograft chips, and an experimental phosphoserine-rich nanofiber scaffold [S(P) gel] were compared in their ability to promote cell adhesion, proliferation/survival, growth factor binding/release, and osteogenic gene expression. Human preosteoblasts were found to adhere most efficiently to the S(P) gel, and the growth/survival was greatest on the S(P) and ACS scaffolds, with minimal growth seen on the allograft and Ceramic #3. In bone morphogenetic protein-2 (BMP-2) binding/release assays, ACS demonstrated a burst release pattern, whereas the allograft and the ceramics inefficiently released BMP-2. The S(P) gel showed the most ideal rates of growth factor binding and release. QPCR analyses showed significant differences in the CXCL12, CXCR4, and RANKL transcripts among the cells grown on these various scaffolds. Although some scaffolds showed an advantage over others in individual parameters, the nanofiber gel appears to provide the optimal balance in the factors important to osteoinductivity evaluated here.

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Complications in the Use of rhBMP-2 in PEEK Cages for Interbody Spinal Fusions

Abstract: PEEK cages and rhBMP-2 when used in spinal fusion give consistently good fusion rates. However, the early role of BMP in the resorptive phase may cause loosening, cage migration, and subsidence.

Cited by 181 publications

References 25 publications

Cage subsidence in lateral interbody fusion with transpsoas approach: intraoperative endplate injury or late-onset settling

Cage subsidence in lateral interbody fusion with transpsoas approach: intraoperative endplate injury or late-onset settling

Nanocomposite therapy as a more efficacious and less inflammatory alternative to bone morphogenetic protein‐2 in a rodent arthrodesis model

A Comparative Evaluation of Factors Influencing Osteoinductivity Among Scaffolds Designed for Bone Regeneration

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