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Orthop Traumatol Surg Res. 2019 Jul 16. pii: S1877-0568(19)30191-4. doi: 10.1016/j.otsr.2019.04.023. [Epub ahead of print]

rhBMP-2 (Recombinant Human Bone Morphogenetic Protein-2) In real world spine surgery. A phase IV, National, multicentre, retrospective study collecting data from patient medical files in French spinal centres.

Author information

1
Neurochirurgie, Générale de Santé - Hôpital Privé Clairval, Serarl Neuro Val Redon, 317, boulevard du Redon, Marseille 13009, France.
2
Chirurgie Orthopedique et Traumatologie, Hôpital Privé Jean-Mermoz, Ramsay Générale de Santé, 24, avenue Paul-Santy, Lyon 69008, France.
3
Chirurgie Orthopedique et Traumatologie, Clinique Médipole Garonne, 45, rue de Gironis, CS 13624, Toulouse 311036, France.
4
Neurochirurgie, CHU Nice - Hôpital Pasteur, BP 69, Nice 06002, France.
5
Neurochirurgie, Service de Neurochirurgie la Timone, PR Dufour, 264, rue Saint Pierre, 13385 Marseille, France.
6
Service de Chirurgie du rachis, Hôpitaux Universitaires de Strasbourg - Hautepierre, 2, avenue Molière, Strasbourg 67200, France; Hôpital Civil, Pavillon chirurgical B, 1, place de l'hôpital, BP 426, Strasbourg 67091200, France.
7
Polyclinique bordeaux nord aquitaine, lab deterca univ bordeaux, 15-35, rue Boucher, Bordeaux 33000, France.
8
Ortho-rachis 2, CHU Pellegrin tripode, Bordeaux 33076, France; Neurochirurgie, Clinique Du Parc, 9bis, rue de la Piot, Saint-Priest en Jarez 42270, France.
9
Neurochirurgie, Nouvelle Clinique de l'Union, boulevard de Ratalens-Saint-Jean, BP 36, Saint-Jean 31240, France.
10
Neurochirurgie, Clinique Ambroise-Paré, 25-27 boulevard Victor Hugo, Neuilly-sur-seine 92200, France.
11
Neurochirurgie, Hôpital Cochin, 27, rue du Faubourg Saint-Jacques, Paris 75014, France.
12
Chirurgie Orthopedique et Traumatologie, CHU Nantes - Hôpital Saint-Jacques, 85, rue Saint-Jacques, Nantes Cedex 44093, France. Electronic address: norbert.passuti@chu-nantes.fr.

Abstract

BACKGROUND:

This is a Phase IV, national, multicentre, retrospective study to observe the real-world use of rhBMP-2 in France.

HYPOTHESIS:

There was no statistical hypothesis, the statistical analyses were descriptive in nature.

PATIENTS AND METHODS:

Data was collected from patient medical files in 10 French spinal centres. Primary objectives were to understand which patients were treated with rhBMP-2, commercialised in Europe as InductOs™ and how rhBMP-2 was used during spinal fusion surgery in France between 2011 and 2012.

RESULTS:

Four hundred patients (634 levels) treated with rhBMP-2 were included in the analysis. The most frequent primary diagnostic indication for rhBMP-2 use was degenerative disc disease (DDD; 129/400; 32.3% of patients) followed by spondylolisthesis (119/400; 29.8%), deformity (59/400; 14.8%) and pseudoarthrosis (29/400; 7.3%). The most frequently treated level was L4-L5 (33.8% of levels in 53.5% of patients); followed by L5-S1 (29.8%, 47.3%), L3-L4 (16.7%, 26.5%), and L2-L3 (7.3%, 11.5%), all other levels (less than 5% of patients). No interbody fusion device was used in 42.7% of levels. Wetted matrix of rhBMP-2 was placed in the interbody space in 58.4% of levels (370/634). The most common procedure for rhBMP-2 treatment was posterior lumbar fusion (PLF) (221/634; 34.9% of levels), followed by anterior lumbar interbody fusion (ALIF) (188/634; 29.7%), posterior lumbar interbody fusion (PLIF) (111/634; 17.5%), lateral lumbar interbody fusion (LLIF) (106/634; 16.7%), transforaminal lumbar interbody fusion (TLIF) (4/634; 0.6%) and 'other' (4/634; 0.6%). Thirty-one adverse events of Interest (AEI) were recorded in 27 patients. One AEI was considered related to rhBMP-2. Unplanned secondary spine interventions at index level treated with rhBMP-2 were required in 4 patients.

DISCUSSION:

In years 2011 and 2012 when the surgeries captured in this retrospective study were done, rhBMP-2 was indicated for single level (L4-S1) anterior lumbar spine fusion as a substitute for autogenous bone graft in adults with DDD. The most common procedure for the treatment with rhBMP-2 was PLF (off-label use), followed by ALIF (on-label use). The safety findings confirm a predictable and manageable safety profile.

LEVEL OF EVIDENCE:

IV.

KEYWORDS:

France; Fusion; InductOs; rh-BMP-2

PMID:
31324520
DOI:
10.1016/j.otsr.2019.04.023

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