A Prospective, Randomized, Controlled, Multicenter Study of Osteogenic Protein-1 in Instrumented Posterolateral Fusions

Delawi, Diyar; Dhert, Wouter J.A.; Rillardon, L.; Gay, Emmanuel; Prestamburgo, Domenico; García-Fernández, Carlos; Guerado, Enrique; Specchia, Nicola; Susante, Job L C van; Verschoor, Nico; Ufford, Henriëtte Quarles van; Oner, F. Cumhur

doi:10.1097/brs.0b013e3181d3cf28

Cited by 43 publications

(35 citation statements)

References 21 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…This was in contrast to the results reported in a previous prospective randomized pilot study involving 36 patients, by the same group of authors. 164 Fusion rates reported in this study were 63% in the OP-1 group and 67% in the autograft group (p = 0.95), with no significant differences in Oswestry scores between the two (p = 0.56). The authors previous conclusions that OP-1 combined with locally obtained autograft was a safe and effective alternative for iliac crest autograft was overturned in the newer study and it was asserted that OP-1 cannot be recommended in instrumented posterolateral lumbar fusion procedures.…”

Section: Osteogenic Protein 1 (Op-1) In Lumbar Spinementioning

confidence: 75%

Bone substitutes and expanders in Spine Surgery: A review of their fusion efficacies

et al. 2016

View full text Add to dashboard Cite

Study Design A narrative review of literature. ObjectiveThis manuscript intends to provide a review of clinically relevant bone substitutes and bone expanders for spinal surgery in terms of efficacy and associated clinical outcomes, as reported in contemporary spine literature. Summary of Background DataEver since the introduction of allograft as a substitute for autologous bone in spinal surgery, a sea of literature has surfaced, evaluating both established and newly emerging fusion alternatives. An understanding of the available fusion options and an organized evidence-based approach to their use in spine surgery is essential for achieving optimal results. MethodsA Medline search of English language literature published through March 2016 discussing bone graft substitutes and fusion extenders was performed. All clinical studies reporting radiological and/or patient outcomes following the use of bone substitutes were reviewed under the broad categories of Allografts, Demineralized Bone Matrices (DBM), Ceramics, Bone Morphogenic proteins (BMPs), Autologous growth factors (AGFs), Stem cell products and Synthetic Peptides. These were further grouped depending on their application in lumbar and cervical spine surgeries, deformity correction or other miscellaneous procedures viz. trauma, infection or tumors; wherever data was forthcoming. Studies in animal populations and experimental in vitro studies were excluded. Primary endpoints were radiological fusion rates and successful clinical outcomes. ResultsA total of 181 clinical studies were found suitable to be included in the review. More than a third of the published articles (62 studies, 34.25%) focused on BMP. Ceramics (40 studies) and Allografts (39 studies) were the other two highly published groups of bone substitutes. Highest radiographic fusion rates were observed with BMPs, followed by allograft and DBM. There were no significant differences in the reported clinical outcomes across all classes of bone substitutes. ConclusionsThere is a clear publication bias in the literature, mostly favoring BMP. Based on the available data, BMP is however associated with the highest radiographic fusion rate. Allograft is also very well corroborated in the literature. The use of DBM as a bone expander to augment autograft is supported, especially in the lumbar spine. Ceramics are also utilized as bone graft extenders and results are generally supportive, although limited. The use of autologous growth factors is not substantiated at this time. Cell matrix or stem cell-based products and the synthetic peptides have inadequate data. More comparative studies are needed to evaluate the efficacy of bone graft substitutes overall.keywords: bone substitutes, allografts, demineralized bone matrix (dbm), spine fusion, ceramics, β tricalcium phosphate (β-tcp), hydroxyapatite, rhbmp-2, osteogenic protein-1 (op-1), autologous growth factors, i-factor, synthetic peptides volume 10 article 33

show abstract

Section: Osteogenic Protein 1 (Op-1) In Lumbar Spinementioning

confidence: 75%

Bone substitutes and expanders in Spine Surgery: A review of their fusion efficacies

et al. 2016

View full text Add to dashboard Cite

show abstract

“…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

View full text Add to dashboard Cite

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.

show abstract

“…The lack of full premarket approval in the decade since the OP-1 implant first received humanitarian device exemption approval in 2002 for use in trauma patients suggests that a clear demonstration of clinical effectiveness for this product has been lacking. 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 .…”

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

View full text Add to dashboard Cite

A Prospective, Randomized, Controlled, Multicenter Study of Osteogenic Protein-1 in Instrumented Posterolateral Fusions

Cited by 43 publications

References 21 publications

Bone substitutes and expanders in Spine Surgery: A review of their fusion efficacies

Bone substitutes and expanders in Spine Surgery: A review of their fusion efficacies

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

2011 AOA Symposium: Tissue Engineering and Tissue Regeneration

Contact Info

Product

Resources

About