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2. Feasibility and safety of treating non-unions in tibia, femur and humerus with autologous, expanded, bone marrow-derived mesenchymal stromal cells associated with biphasic calcium phosphate biomaterials in a multicentric, non-comparative trial

Author

Gómez-Barrena, Enrique, Rosset, Philippe, Gebhard, Florian, Hernigou, Philippe, Baldini, Nicola, Rouard, Helène, Sensebé, Luc, Gonzalo-Daganzo, Rosa M., Giordano, Rosaria, Padilla-Eguiluz, Norma, García-Rey, Eduardo, Cordero-Ampuero, José, Rubio-Suárez, Juan Carlos, Stanovici, Julien, Ehrnthaller, Christian, Huber-Lang, Markus, Flouzat-Lachaniette, Charles Henri, Chevallier, Nathalie, Donati, Davide Maria, Ciapetti, Gabriela, Fleury, Sandrine, Fernandez, Manuel-Nicolás, Cabrera, José-Rafael, Avendaño-Solá, Cristina, Montemurro, Tiziana, Panaitescu, Carmen, Veronesi, Elena, Rojewski, Markus Thomas, Lotfi, Ramin, Dominici, Massimo, Schrezenmeier, Hubert, and Layrolle, Pierre

Published
2019
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3. Simultaneous Evaluation of Bone Cut and Implant Placement Accuracy in Robotic-Assisted Total Knee Arthroplasty.

Author

Cosendey, Killian, Stanovici, Julien, Cadas, Hugues, Omoumi, Patrick, Jolles, Brigitte M., and Favre, Julien

Subjects
*TOTAL knee replacement, *MULTI-degree of freedom, *ANATOMICAL planes, *COMPUTED tomography
Abstract

Background: This study aimed to evaluate the accuracy of bone cuts and implant placements, simultaneously, for total knee arthroplasty (TKA) performed using a system with an active robotic arm. Methods: Two experienced orthopaedic surgeons performed TKA on ten cadaveric legs. Computed tomography scans were performed to compare the bone cuts and implant placements with the preoperative planning. The differences between the planned and actual bone cuts and implant placements were assessed using positional and angular errors in the three anatomical planes. Additionally, the cut–implant deviations were calculated. Statistical analysis was performed to detect systematic errors in the bone cuts and implant placements and to quantify the correlations between these errors. Results: The root-mean-square (RMS) errors of the bone cuts (with respect to the planning) were between 0.7–1.5 mm and 0.6–1.7°. The RMS implant placement errors (with respect to the planning) varied between 0.6–1.6 mm and 0.4–1.5°, except for the femur and tibia in the sagittal plane (2.9°). Systematic errors in the bone cuts and implant placements were observed, respectively, in three and two degrees of freedom. For cut–implant deviations, the RMS values ranged between 0.3–2.0 mm and 0.6–1.9°. The bone cut and implant placement errors were significantly correlated in eight degrees-of-freedom (ρ ≥ 0.67, p < 0.05). Conclusions: With most of the errors below 2 mm or 2°, this study supported the value of active robotic TKA in achieving accurate bone cuts and implant placements. The findings also highlighted the need for both accurate bone cuts and proper implantation technique to achieve accurate implant placements. [ABSTRACT FROM AUTHOR]

Published
2024
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5. An Expert-Supervised Registration Method for Multiparameter Description of the Knee Joint Using Serial Imaging.

Author

UCL - SSS/IREC/IMAG - Pôle d'imagerie médicale, UCL - (SLuc) Service de radiologie, Babel, Hugo, Omoumi, Patrick, Cosendey, Killian, Stanovici, Julien, Cadas, Hugues, Jolles, Brigitte M, Favre, Julien, UCL - SSS/IREC/IMAG - Pôle d'imagerie médicale, UCL - (SLuc) Service de radiologie, Babel, Hugo, Omoumi, Patrick, Cosendey, Killian, Stanovici, Julien, Cadas, Hugues, Jolles, Brigitte M, and Favre, Julien

Abstract

As knee osteoarthritis is a disease of the entire joint, our pathophysiological understanding could be improved by the characterization of the relationships among the knee components. Diverse quantitative parameters can be characterized using magnetic resonance imaging (MRI) and computed tomography (CT). However, a lack of methods for the coordinated measurement of multiple parameters hinders global analyses. This study aimed to design an expert-supervised registration method to facilitate multiparameter description using complementary image sets obtained by serial imaging. The method is based on three-dimensional tissue models positioned in the image sets of interest using manually placed attraction points. Two datasets, with 10 knees CT-scanned twice and 10 knees imaged by CT and MRI were used to assess the method when registering the distal femur and proximal tibia. The median interoperator registration errors, quantified using the mean absolute distance and Dice index, were ≤0.45 mm and ≥0.96 unit, respectively. These values differed by less than 0.1 mm and 0.005 units compared to the errors obtained with gold standard methods. In conclusion, an expert-supervised registration method was introduced. Its capacity to register the distal femur and proximal tibia supports further developments for multiparameter description of healthy and osteoarthritic knee joints, among other applications.

Published
2022

10. Early efficacy evaluation of mesenchymal stromal cells (MSC) combined to biomaterials to treat long bone non-unions

Author

Gómez-Barrena, Enrique, primary, Padilla-Eguiluz, Norma, additional, Rosset, Philippe, additional, Gebhard, Florian, additional, Hernigou, Philippe, additional, Baldini, Nicola, additional, Rouard, Helène, additional, Sensebé, Luc, additional, Gonzalo-Daganzo, Rosa-María, additional, Giordano, Rosaria, additional, García-Rey, Eduardo, additional, Cordero-Ampuero, José, additional, Rubio-Suárez, Juan Carlos, additional, García-Simón, Marta Dominguez, additional, Stanovici, Julien, additional, Ehrnthaller, Christian, additional, Huber-Lang, Markus, additional, Flouzat-Lachaniette, Charles Henri, additional, Chevallier, Nathalie, additional, Donati, Davide Maria, additional, Spazzoli, Benedetta, additional, Ciapetti, Gabriela, additional, Fleury, Sandrine, additional, Fernandez, Manuel-Nicolás, additional, Cabrera, José-Rafael, additional, Avendaño-Solá, Cristina, additional, Montemurro, Tiziana, additional, Panaitescu, Carmen, additional, Veronesi, Elena, additional, Rojewski, Markus Thomas, additional, Lotfi, Ramin, additional, Dominici, Massimo, additional, Schrezenmeier, Hubert, additional, and Layrolle, Pierre, additional

Published
2020
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17. Percutaneous grafting with bone marrow autologous concentrate for open tibia fractures: analysis of forty three cases and literature review.

Author

Nail, Louis-Romée, Stanovici, Julien, Fournier, Joseph, Splingard, Marie, Domenech, Jorge, and Rosset, Philippe

Subjects
*BONE marrow transplantation, *AUTOTRANSPLANTATION, *BONE grafting, *TIBIA injuries, *MESENCHYMAL stem cells, *COMPOUND fractures, *THERAPEUTICS
Abstract

Purpose: Tibial fractures are the most common lower limb fractures. Some criteria such as open fractures and increasing open stage are known to be associated with high delayed union and pseudarthrosis rate. In cases of delayed or nonunion, classical treatment is autologous cancelous bone graft which is associated with high morbidity rate. The ideal treatment would be a percutaneous harvesting and grafting technique. As bone marrow autologous concentrate (BMAC) presents both advantages, we evaluated this technique from 2002 to 2007. Methods: This was a retrospective study of 43 cases of open tibial fractures with initial surgical treatment. The criteria of inclusion were open fracture and nonunion, delayed union or suspicion of delayed union. Results: In 23 cases (53.5 %) BMAC was successful. The success group had received significantly more CFU-F than the failure group (469 vs 153.10, p = 0.013). A threshold of 360.10 CFU-F grafted could be established over which there was 100 % success. BMAC done before 110 days after fracture had 47 % success and BMAC done since 110 days after fracture had 73 % success. BMAC success rate decreased with increasing initial fracture skin open stage. There was no BMAC success in cases of a fracture with a remaining gap of more than 4 mm. We had no complications with the technique at the iliac harvesting zone and tibia injection point. Conclusion: BMAC is a technique that should be considered as one of the different alternatives for management of long-bone delayed and nonunion because of its effectiveness, low complication rate, preservation of bone stock and low cost. [ABSTRACT FROM AUTHOR]

Published
2014
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18. Feasibility and safety of treating non-unions in tibia, femur and humerus with autologous, expanded, bone marrow-derived mesenchymal stromal cells associated with biphasic calcium phosphate biomaterials in a multicentric, non-comparative trial

Author

Nicola Baldini, Elena Veronesi, Nathalie Chevallier, Enrique Gómez-Barrena, Philippe Rosset, Pierre Layrolle, Philippe Hernigou, Cristina Avendaño-Solá, Gabriela Ciapetti, Sandrine Fleury, Massimo Dominici, Tiziana Montemurro, Rosaria Giordano, José Cordero-Ampuero, Jose Rafael Cabrera, M.N. Fernández, Hélène Rouard, Juan Carlos Rubio-Suárez, Ramin Lotfi, Markus Rojewski, Christian Ehrnthaller, Luc Sensebé, Hubert Schrezenmeier, Markus Huber-Lang, Florian Gebhard, Charles Henri Flouzat-Lachaniette, Norma G. Padilla-Eguiluz, Julien Stanovici, Davide Maria Donati, Carmen Panaitescu, Rosa Gonzalo-Daganzo, Eduardo García-Rey, Servicio de Cirugía Ortopédica y Traumatología [Madrid, Spain], Universidad Autonoma de Madrid (UAM)-Hospital Universitario La Paz-IdiPAZ and Facultad de Medicina [Madrid, Spain], Service de Chirurgie Orthopédique et Traumatologique 2 [CHU Tours], Hôpital Trousseau (Tours)-Université Francois Rabelais [Tours]-Centre Hospitalier Régional Universitaire de Tours (CHRU TOURS), Department of Traumatology, Hand-, Plastic-, and Reconstructive Surgery [Ulm, Germany], Universität Ulm - Ulm University [Ulm, Allemagne]-Center of Surgery [Ulm, Germany], Biomécanique cellulaire et respiratoire (BCR), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12)-Centre National de la Recherche Scientifique (CNRS), Laboratory for Orthopaedic Pathophysiology and Regenerative Medicine [Bologna, Italy], University of Bologna-Department of Biomedical and Neuromotor Sciences [Bologna, Italy], Istituto Ortopedico Rizzoli [Bologna, Italy]-Istituto Ortopedico Rizzoli [Bologna, Italy], Etablissement Français du Sang Ile de France (EFS), Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-CHU Necker - Enfants Malades [AP-HP], STROMALab, Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Ecole Nationale Vétérinaire de Toulouse (ENVT), Institut National Polytechnique (Toulouse) (Toulouse INP), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Institut National Polytechnique (Toulouse) (Toulouse INP), Université Fédérale Toulouse Midi-Pyrénées-Institut National de la Santé et de la Recherche Médicale (INSERM)-Etablissement Français du Sang-Centre National de la Recherche Scientifique (CNRS), Servicio de Hematología [Madrid, Spain], Universidad Autonoma de Madrid (UAM)-Hospital Universitario Puerta de Hierro-Majadahonda [Madrid, Spain], Cell Factory, Center for Cellular Therapy and Cryobiology [Milano, Italy], Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico, Victor Babes University of Medicine and Pharmacy [Timisoara, Romania], Laboratory of Cellular Therapies [Modena, Italy], University - Hospital of Modena and Reggio Emilia [Modena, Italy]- Department of Medical and Surgical Sciences for Children & Adults [Modena, Italy], Institute for Clinical Transfusion Medicine and Immunogenetic Ulm [Ulm, Germany], Institut für Klinische Transfusionsmedizin und Immungenetik Ulm -IKT [Ulm, Germany], Physiopathologie de la Résorption Osseuse et Thérapie des Tumeurs Osseuses Primitives, Université de Nantes (UN)-Institut National de la Santé et de la Recherche Médicale (INSERM), EU-FP7-HEALTH-2009, REBORNE Project (GA: 241876)., Hospital Universitario La Paz-IdiPAZ and Facultad de Medicina [Madrid, Spain]-Universidad Autonoma de Madrid (UAM), Centre Hospitalier Régional Universitaire de Tours (CHRU TOURS)-Université Francois Rabelais [Tours]-Hôpital Trousseau, Centre Hospitalier Régional Universitaire de Tours (CHRU Tours)-Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-CHU Necker - Enfants Malades [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Centre National de la Recherche Scientifique (CNRS)-Ecole Nationale Vétérinaire de Toulouse (ENVT), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées-Etablissement Français du Sang-Institut National de la Santé et de la Recherche Médicale (INSERM), Victor Babeş University of Medicine and Pharmacy (UMFT), Physiopathologie des Adaptations Nutritionnelles (PhAN), Université de Nantes - UFR de Médecine et des Techniques Médicales (UFR MEDECINE), Université de Nantes (UN)-Université de Nantes (UN)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), UAM. Departamento de Cirugía, UAM. Departamento de Farmacología, UAM. Departamento de Medicina, Instituto de Investigación Sanitaria Hospital Universitario de La Paz (IdiPAZ), Centre Hospitalier Régional Universitaire de Tours (CHRU Tours)-Université Francois Rabelais [Tours]-Hôpital Trousseau, Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), Gómez-Barrena, Enrique, Rosset, Philippe, Gebhard, Florian, Hernigou, Philippe, Baldini, Nicola, Rouard, Helène, Sensebé, Luc, Gonzalo-Daganzo, Rosa M., Giordano, Rosaria, Padilla-Eguiluz, Norma, García-Rey, Eduardo, Cordero-Ampuero, José, Rubio-Suárez, Juan Carlo, Stanovici, Julien, Ehrnthaller, Christian, Huber-Lang, Marku, Flouzat-Lachaniette, Charles Henri, Chevallier, Nathalie, Donati, Davide Maria, Ciapetti, Gabriela, Fleury, Sandrine, Fernandez, Manuel-Nicolá, Cabrera, José-Rafael, Avendaño-Solá, Cristina, Montemurro, Tiziana, Panaitescu, Carmen, Veronesi, Elena, Rojewski, Markus Thoma, Lotfi, Ramin, Dominici, Massimo, Schrezenmeier, Hubert, Layrolle, Pierre, Universidad Autónoma de Madrid (UAM)-Hospital Universitario La Paz-IdiPAZ and Facultad de Medicina [Madrid, Spain], Centre Hospitalier Régional Universitaire de Tours (CHRU Tours)-Hôpital Trousseau, Centre Hospitalier Régional Universitaire de Tours (CHRU Tours)-Université Francois Rabelais [Tours], University of Bologna/Università di Bologna-Department of Biomedical and Neuromotor Sciences [Bologna, Italy], Universidad Autónoma de Madrid (UAM)-Hospital Universitario Puerta de Hierro-Majadahonda [Madrid, Spain], Institut National de la Recherche Agronomique (INRA)-Université de Nantes (UN), and maurice, sandrine

Subjects
Calcium Phosphates, Biocompatible Materials, 02 engineering and technology, Bone tissue engineering, Fractures, Bone, Femur, media_common, [SDV.MHEP.RSOA] Life Sciences [q-bio]/Human health and pathology/Rhumatology and musculoskeletal system, 0303 health sciences, [SDV.MHEP] Life Sciences [q-bio]/Human health and pathology, 021001 nanoscience & nanotechnology, 3. Good health, Clinical trial, medicine.anatomical_structure, [SDV.MHEP.RSOA]Life Sciences [q-bio]/Human health and pathology/Rhumatology and musculoskeletal system, Mechanics of Materials, [SDV.IB]Life Sciences [q-bio]/Bioengineering, 0210 nano-technology, medicine.medical_specialty, Bioceramic, Medicina, Biophysics, Ceramics and Composite, Bioengineering, Mesenchymal Stem Cell Transplantation, Non-union, Transplantation, Autologous, Non union, Expanded autologous BM-hMSC, Biomaterials, 03 medical and health sciences, medicine, media_common.cataloged_instance, Humans, Humerus, Tibia, European union, [SDV.IB.BIO]Life Sciences [q-bio]/Bioengineering/Biomaterials, 030304 developmental biology, Cell Proliferation, [SDV.IB] Life Sciences [q-bio]/Bioengineering, business.industry, Mesenchymal stem cell, Mesenchymal Stem Cells, ATMP, Biomaterial, Surgery, [SDV.IB.BIO] Life Sciences [q-bio]/Bioengineering/Biomaterials, Biophysic, Fractures, Ununited, Ceramics and Composites, Feasibility Studies, Bone marrow, business, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology
Abstract

Background: ORTHO-1 is a European, multicentric, first in human clinical trial to prove safety and feasibility after surgical implantation of commercially available biphasic calcium phosphate bioceramic granules associated during surgery with autologous mesenchymal stromal cells expanded from bone marrow (BM-hMSC) under good manufacturing practices, in patients with long bone pseudarthrosis. Methods: Twenty-eight patients with femur, tibia or humerus diaphyseal or metaphyso-diaphyseal non-unions were recruited and surgically treated in France, Germany, Italy and Spain with 100 or 200 million BM-hMSC/mL associated with 5–10 cc of bioceramic granules. Patients were followed up during one year. The investigational advanced therapy medicinal product (ATMP) was expanded under the same protocol in all four countries, and approved by each National Competent Authority. Findings: With safety as primary end-point, no severe adverse event was reported as related to the BM-hMSC. With feasibility as secondary end-point, the participating production centres manufactured the BM-hMSC as planned. The ATMP combined to the bioceramic was surgically delivered to the non-unions, and 26/28 treated patients were found radiologically healed at one year (3 out of 4 cortices with bone bridging). Interpretation: Safety and feasibility were clinically proven for surgical implantation of expanded autologous BM-hMSC with bioceramic. Funding: EU-FP7-HEALTH-2009, REBORNE Project (GA: 241876)., The research leading to these results has received funding from the European Research Council under the European Union's Seventh Framework Programme (FP7/FP7-HEALTH-2009); REBORNE Project (GA: 241876)

Published
2017

19. [Enhanced recovery after prosthetic surgery].

Author

Heutschi-Öztürk H and Stanovici J

Subjects
Humans, Patient Discharge, Time Factors, Length of Stay, Postoperative Complications, Prostheses and Implants
Abstract

The enhanced recovery after surgery (ERAS) is a proven concept in many surgical disciplines since the early 2000s. Studies agree benefit in prosthetic surgery and it has been shown to lead to improved practices and results permitting a faster discharge to home with lesser morbidity and mortality. It implies a cohesion in the message delivery and the general practitioner plays a central role. The collection and analysis of the data is fundamental to continuously improve the protocol and thus the care of patients. These protocols are a step towards outpatient management in this kind of surgery., Competing Interests: Les auteurs n’ont déclaré aucun conflit d’intérêts en relation avec cet article.

Published
2020

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