Six-Year Outcomes of Anterior Lumbar Interbody Arthrodesis with Use of Interbody Fusion Cages and Recombinant Human Bone Morphogenetic Protein-2

Burkus, J. Kenneth; Gornet, Matthew F.; Schuler, Thomas C.; Kleeman, Thomas J.; Zdeblick, Thomas A.

doi:10.2106/jbjs.g.01485

Cited by 138 publications

(105 citation statements)

References 20 publications

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“…7 No significant difference in outcome at 6 years was observed when compared with the previously published data obtained at 2 years after surgery. Geibel et al reported a 100% fusion rate with an 89% patient satisfaction rate in 48 patients undergoing 1-and 2-level instrumented PLIF with rhBMP-2 and posterolateral fusion.…”

Section: Bone Morphogenetic Proteinsmentioning

confidence: 54%

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Guideline update for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 16: Bone graft extenders and substitutes as an adjunct for lumbar fusion

Kaiser

Groff

Watters

et al. 2014

SPI

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In an attempt to enhance the potential to achieve a solid arthrodesis and avoid the morbidity of harvesting autologous iliac crest bone (AICB) for a lumbar fusion, numerous alternatives have been investigated. The use of these fusion adjuncts has become routine despite a lack of convincing evidence demonstrating a benefit to justify added costs or potential harm. Potential alternatives to AICB include locally harvested autograft, calcium-phosphate salts, demineralized bone matrix (DBM), and the family of bone morphogenetic proteins (BMPs). In particular, no option has created greater controversy than the BMPs. A significant increase in the number of publications, particularly with respect to the BMPs, has taken place since the release of the original guidelines. Both DBM and the calciumphosphate salts have demonstrated efficacy as a graft extender or as a substitute for AICB when combined with local autograft. The use of recombinant human BMP-2 (rhBMP-2) as a substitute for AICB, when performing an interbody lumbar fusion, is considered an option since similar outcomes have been observed; however, the potential for heterotopic bone formation is a concern. The use of rhBMP-2, when combined with calcium phosphates, as a substitute for AICB, or as an extender, when used with local autograft or AICB, is also considered an option as similar fusion rates and clinical outcomes have been observed. Surgeons electing to use BMPs should be aware of a growing body of literature demonstrating unique complications associated with the use of BMPs.

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Section: Bone Morphogenetic Proteinsmentioning

confidence: 54%

“…However, no material has received more attention and generated more controversy than the family of BMPs. There are numerous papers that demonstrate the fusion potential of BMPs; 2,7,18,19 however, complications associated with their use have been reported. 29,47,50 Whether the benefits of BMPs justify the costs remains to be determined.…”

Section: Rationalementioning

confidence: 99%

Guideline update for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 16: Bone graft extenders and substitutes as an adjunct for lumbar fusion

Kaiser

Groff

Watters

et al. 2014

SPI

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“…Data from a non-comparative 6 year follow-up study of 128 patients treated with dibotermin alfa/ACIM indicated that the rate of failure-related second surgery reduced from 6.7% during the first 24 months to 3.7% during the period 2-6 years; and the percentage of patients working at 6 months (63%) was higher than pre-operation (52%), which was sustained at 6 years (68%) 35 . Nevertheless, further research is required to study the long-term costs and health benefits of dibotermin alfa/ACIM.…”

Section: Discussionmentioning

confidence: 99%

Is dibotermin alfa a cost-effective substitute for autologous iliac crest bone graft in single level lumbar interbody spine fusion?

Svedbom

Paech²,

Leonard

et al. 2015

Current Medical Research and Opinion

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Objectives:To evaluate the cost-effectiveness of dibotermin alfa compared with autologous iliac crest bone graft (ICBG) for patients undergoing single level lumbar interbody spinal fusion in a UK hospital setting. Methods:An individual patient data (IPD) meta-analysis of six randomized controlled clinical trials and two single arm trials compared dibotermin alfa on an absorbable collagen implantation matrix (ACIM) (n ¼ 456) and ICBG (n ¼ 244) on resource use, re-operation rates, and SF-6D (Short form 6-dimension) health utility (total N ¼ 700). Failure-related second surgery, operating time, post-operative hospital stay, and quality-adjusted life years (QALYs) derived from the IPD meta-analysis were included as inputs in an economic evaluation undertaken to assess the cost-effectiveness of dibotermin alfa/ACIM versus ICBG for patients undergoing single level lumbar interbody spinal fusion. A four year time horizon and the United Kingdom (UK) National Health Service (NHS) and Personal Social Services (PSS) perspective was adopted in the base case, with sensitivity analyses performed to gauge parameter uncertainty. Results:In the base case analysis, patients treated using dibotermin alfa/ACIM (12 mg pack) accrued 0.055 incremental QALYs at an incremental cost of £737, compared with patients treated with ICBG. This resulted in an incremental cost-effectiveness ratio (ICER) of £13,523, indicating that at a willingness-topay threshold of £20,000, dibotermin alfa/ACIM is a cost-effective intervention relative to ICBG from the NHS and PSS perspective. Conclusions:In a UK hospital setting, dibotermin alfa/ACIM is a cost-effective substitute for ICBG for patients who require lumbar interbody arthrodesis.

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“…However, BMP has the benefits of decreased operative time, blood loss, donor site morbidity, transmission of infection associated with use of allograft, and rate of pseudarthrosis. 3,9 In a retrospective analysis of 47 patients conducted at our institution, the use of BMP in pediatric patients undergoing occipitocervical, cervical, and thoracic, lumbar, or lumbosacral spine fusion led to no cases of new cancers, tumor degeneration, or metastasis at the 24-month follow-up. 37 To the best of our knowledge, no other studies have been published reporting the use of transsacral pedicle screws in adolescents with high-grade spondylolisthesis.…”

Section: Surgical Techniquesmentioning

confidence: 99%

Transsacral transdiscal L5–S1 screws for the management of high-grade spondylolisthesis in an adolescent

Palejwala

Fridley²,

Jea³

2016

PED

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The surgical management of high-grade spondylolisthesis in adolescents remains a controversial issue. Because the basic procedure, posterolateral fusion, is associated with a significant rate of pseudarthrosis and listhesis progression, there is a pressing need for alternative surgical techniques. In the present report, the authors describe the case of an adolescent patient with significant low-back pain who was found to have Grade IV spondylolisthesis at L5–S1 that was treated with transsacral transdiscal screw fixation. Bilateral pedicle screws were placed starting from the top of the S-1 pedicle, across the L5–S1 intervertebral disc space, and into the L-5 body. At 14 months after surgery, the patient had considerable improvement in his pain and radiographic fusion across L5–S1. The authors conclude that transsacral transdiscal pedicle screws may serve as an efficacious and safe option for the correction of high-grade spondylolisthesis in adolescent patients.

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Six-Year Outcomes of Anterior Lumbar Interbody Arthrodesis with Use of Interbody Fusion Cages and Recombinant Human Bone Morphogenetic Protein-2

Cited by 138 publications

References 20 publications

Guideline update for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 16: Bone graft extenders and substitutes as an adjunct for lumbar fusion

Guideline update for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 16: Bone graft extenders and substitutes as an adjunct for lumbar fusion

Is dibotermin alfa a cost-effective substitute for autologous iliac crest bone graft in single level lumbar interbody spine fusion?

Transsacral transdiscal L5–S1 screws for the management of high-grade spondylolisthesis in an adolescent

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