Ange François Vincentelli1, Marc Szadkowski2, Dominique Vardon3, Stéphane Litrico4, Stéphane Fuentès5, Jean-Paul Steib6, Jean-Charles Le Huec7, Jean Huppert8, Gilles Dubois9, Thibaut Lenoir10, Frédéric Sailhan11, Norbert Passuti12. 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.
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.
Authors: Carol S Palackdkharry; Stephanie Wottrich; Erin Dienes; Mohamad Bydon; Michael P Steinmetz; Vincent C Traynelis Journal: PLoS One Date: 2022-09-30 Impact factor: 3.752