scholarly journals Effective management of bone fractures with the IlluminOss® photodynamic bone stabilization system: initial clinical experience from the European Union registry

2017 ◽  
Vol 9 (1) ◽  
Author(s):  
Thomas Gausepohl ◽  
Dietmar Pennig ◽  
Steffen Heck ◽  
Sascha Gick ◽  
Paul A. Vegt ◽  
...  

The IlluminOss<sup>®</sup> system (IS) uses a light-curable polymer contained within an inflatable balloon catheter, forming a patient customized intramedullary implant. A registry was established in Germany and The Netherlands to prospectively collect technical and clinical outcomes in patients treated with IS for fractures of the phalange, metacarpal, radius, ulna, distal radius, fibula, clavicle and/or olecranon. Humeral, femoral, tibial and pelvic fractures were included under compassionate use. Procedural success included successful placement of the device at the target fracture site and achievement of fracture stabilization. Clinical and radiographic assessments were made postoperatively through 12 months. One hundred thirty two patients (149 fractures) were enrolled with most fractures (85%) resulting from low-energy trauma. Simple fractures predominated (47%) followed by complex (23%) and wedge (16%) fractures. Procedural success was achieved in all patients and no implants required removal or revision. Normal range of motion was realized in 87% of fractures. Radiographically, there was substantial cortical bridging, total dissolution of the fracture line, and complete fracture healing. Across a variety of fracture types, the IS provides a safe and effective approach for rapid healing and functional recovery.

2008 ◽  
Vol 20 (1) ◽  
pp. 220
Author(s):  
C. B. Dores ◽  
J. F. Lima-Neto ◽  
O. C. M. Pereira-Junior ◽  
T. S. Rascado ◽  
D. Passarelli ◽  
...  

The mesenchymal stem cells (MSC) are multipotent cells present in the bone marrow. The plasticity of these cells allows them to be used in cell therapy since they have the potential to replicate as undifferentiated cells and can be induced to differentiate into bone, fat, cartilage, tendon, muscle, and other tissues. The establishment of a pattern to culture MSC is the first step to start further experiments including MSC differentiation, cell therapy, and autologous transplants. In the present study, three dogs presenting non-union bone fractures, with one to two years of evolution, one in the middle third of the femur and the other two on the distal third of the radius and the ulna, were submitted to stem cell transplantation. After general anesthesia (IV) MSCs were aspirated from the head of the humerus from each dog and centrifuged at 1500 rpm for 10 minutes to eliminate the serum and the fat. The material was resuspended in a 1/1 proportion with DMEM High Glucose (GIBCO, Grand Island, NY, USA) and centrifuged with 7 mL of Ficoll-Paque (density 1.077 g mL–1; Amersham Biosciences, Sao Paulo, Brazil) at 1500 rpm for 40 min. The middle ring formed was aspirated and washed in DMEM High Glucose. The pellet was resuspended in DMEM High glucose with 20% fetal calf serum, penicillin, amphotericin B, and streptomycin. Primary cultures were established and subcultivated for as many as 4 passages. MSCs were cultured in humidified incubators with 5% CO2 in air and allowed to adhere for 120 h, followed by media change every 3 to 4 days. When cultures reached more than 90% confluence, adherent cells were detached with 0.05% trypsin-EDTA (GIBCO) and replanted (passage) at a density of 2 � 106 per 175 cm2 flask. To confirm the lineage of the MSCs, anti-vimentin immunocytochemistry was performed. After about 15 days of culture the cells were resuspended at a concentration of 2 � 107 cells mL–1 and prepared for transfer. The animals were subjected to a surgical procedure where the metallic implant (n = 3) and the fibrous tissue present in the non-union fracture site were removed and the fracture was stabilized with the use of steel bone plate and screws. At the end of the fracture stabilization, the cells were transferred directly into the fracture site. Radiographic exams were performed on the post-surgical site immediately after the surgery and monthly until complete bone healing, which was considered satisfactory 5 to 8 months after the surgery in all animals. The clinical results indicate that the therapy with homologous mesenchymal stem cells is a promising and efficient method to treat non-union bone fractures in dogs. This work was supported by FAPESP (grants 06/54575-0 and 06/56738-4).


2018 ◽  
Vol 69 (2) ◽  
pp. 429-433
Author(s):  
Solyom Arpad ◽  
Cristian Trambitas ◽  
Ecaterina Matei ◽  
Eugeniu Vasile ◽  
Fodor Pal ◽  
...  

Osteoplasty, is a procedure mostly applied in complicated bone fractures. Nowadays this method is widely used in primary fracture treatment while the native bone graft is progressively replaced with various synthetic bone substitutes. From the numerous bone grafts we�d like to mention a representative of ceramics, the S53P4 bioactive glass. (BonAlive�). The aim of this study was to investigate the healing process of different fracture types generated on rabbit femurs. During this experiment we used seven common European rabbits. We separated these animals into two groups; in the first group we surgically generated a total fracture in the middle 1/3 of the femur, while in the second group, we produced only a bone defect on the femur. The osteoplasty was carried out with bioactive glass and autologous bone grafts. The radiographic follow-up was immediate after the operation and after 3, 6 and 7 weeks. The animals were euthanized after 19, 20 and 21 weeks, for histomorphometric examination of the femur. It was also studied the ionic release from the used bioactive glass at physiological pH and the etching of the glass was studied by Scanning Electron Microscopy.


2021 ◽  
Vol 12 (1) ◽  
Author(s):  
Marc Jayankura ◽  
Arndt Peter Schulz ◽  
Olivier Delahaut ◽  
Richard Witvrouw ◽  
Lothar Seefried ◽  
...  

Abstract Background Overall, 5–10% of fractures result in delayed unions or non-unions, causing major disabilities and a huge socioeconomic burden. Since rescue surgery with autologous bone grafts can cause additional challenges, alternative treatment options have been developed to stimulate a deficient healing process. This study assessed the technical feasibility, safety and preliminary efficacy of local percutaneous implantation of allogeneic bone-forming cells in delayed unions of long bone fractures. Methods In this phase I/IIA open-label pilot trial, 22 adult patients with non-infected delayed unions of long bone fractures, which failed to consolidate after 3 to 7 months, received a percutaneous implantation of allogeneic bone-forming cells derived from bone marrow mesenchymal stem cells (ALLOB; Bone Therapeutics) into the fracture site (50 × 106 to 100 × 106 cells). Patients were monitored for adverse events and need for rescue surgery for 30 months. Fracture healing was monitored by Tomographic Union Score (TUS) and modified Radiographic Union Score. The health status was evaluated using the Global Disease Evaluation (GDE) score and pain at palpation using a visual analogue scale. The presence of reactive anti-human leukocyte antigen (HLA) antibodies was evaluated. Results During the 6-month follow-up, three serious treatment-emergent adverse events were reported in two patients, of which two were considered as possibly treatment-related. None of the 21 patients in the per-protocol efficacy population needed rescue surgery within 6 months, but 2/21 (9.5%) patients had rescue surgery within 30 months post-treatment. At 6 months post-treatment, an improvement of at least 2 points in TUS was reached in 76.2% of patients, the GDE score improved by a mean of 48%, and pain at palpation at the fracture site was reduced by an average of 61% compared to baseline. The proportion of blood samples containing donor-specific anti-HLA antibodies increased from 8/22 (36.4%) before treatment to 13/22 (59.1%) at 6 months post-treatment, but no treatment-mediated allogeneic immune reactions were observed. Conclusion This pilot study showed that the percutaneous implantation of allogeneic bone-forming cells was technically feasible and well tolerated in patients with delayed unions of long bone fractures. Preliminary efficacy evidence is supporting the further development of this treatment. Trial registration NCT02020590. Registered on 25 December 2013. ALLOB-DU1, A pilot Phase I/IIa, multicentre, open proof-of-concept study on the efficacy and safetyof allogeneic osteoblastic cells (ALLOB®) implantation in non-infected delayed-union fractures.


2017 ◽  
Vol 47 (8) ◽  
Author(s):  
Juliana Scarpa da Silveira Almeida ◽  
Débora de Oliveira Garcia ◽  
Renato Camargo Bortholin ◽  
Carlos Amaral Razzino ◽  
Cristiane dos Santos Honsho ◽  
...  

ABSTRACT: Long bone fractures are commonly in surgery routine and several bone imobilization techniques are currently available. Technological progress has enabled to use low cost materials in surgical procedures. Thus, the aim of this study was to evaluate the applicability of polyamide 12 rods, solid and hollow in swine femurs, comparing them through flexion strength. This study had as second aim to fix the locking errors, commom place in interlocking nails, once polyamide 12 allows perforation in any direction by orthopaedic screw. Six groups were used: G1 - eight whole swine femurs; G2 - eight whole swine femurs with drilled medullary canal; G3 - two solid polyamide 12 rods; G4 - two hollow polyamide 12 rods; G5 - eight osteotomized drilled swine femurs with a solid polyamide 12 rod implanted in the medullary canal and locked by four 316L stainless steel screws; and G6 - similar to G5 but using hollow rods instead of solid ones. No significant differences were observed for the modulus of rupture between solid and hollow rods, demonstrating that both rods had similar performances. These results led to the speculation that the addition of other polymers to the hollow rods could increase their strength and thus the bone-implant system. Furthermore, the comparison between G1, G5 and G6 could be analyzed using the finite element method in future. New polymeric materials may be developed based on the data from this study, strengthening the bone-implant system and making possible screws to be placed in any direction, nullifying the detrimental forces on the fracture site.


2010 ◽  
Vol 2 (1) ◽  
pp. 4 ◽  
Author(s):  
Juerg Sonderegger ◽  
Karl R. Grob ◽  
Markus S. Kuster

<!--StartFragment--> <p class="MsoNormal"><span style="font-family: 'Times New Roman', Arial, Helvetica, sans-serif; font-size: medium;"><span style="font-size: 16px;"><span style="font-family: Verdana, Arial, Helvetica, sans-serif; font-size: x-small;"><span style="font-size: 10px;"><p class="MsoNormal">Plate osteosynthesis is one treatment option for the stabilization of long bones. It is widely accepted to achieve bone healing with a dynamic and biological fixation where the perfusion of the bone is left intact and micromotion at the fracture gap is allowed. The indications for a dynamic plate osteosynthesis include distal tibial and femoral fractures, some midshaft fractures, and adolescent tibial and femoral fractures with not fully closed growth plates. Although many lower limb shaft fractures are managed successfully with intramedullary nails, there are some important advantages of open-reduction-and-plate fixation: the risk of malalignment, anterior knee pain, or nonunion seems to be lower. The surgeon performing a plate osteosynthesis has the possibility to influence fixation strength and micromotion at the fracture gap. Long plates and oblique screws at the plate ends increase fixation strength. However, the number of screws does influence stiffness and stability. Lag screws and screws close to the fracture site reduce micromotion dramatically. </p><p class="MsoNormal">Dynamic plate osteosynthesis can be achieved by applying some simple rules: long plates with only a few screws should be used. Oblique screws at the plate ends increase the pullout strength. Two or three holes at the fracture site should be omitted. Lag screws, especially through the plate, must be avoided whenever possible. Compression is not required. Locking plates are recommended only in fractures close to the joint. When respecting these basic concepts, dynamic plate osteosynthesis is a safe procedure with a high healing and a low complication rate. </p></span></span></span></span></p>


2020 ◽  
Vol 2020 ◽  
pp. 1-12
Author(s):  
Xue Ma ◽  
Jian Yang ◽  
Ting Liu ◽  
Jing Li ◽  
Yanyu Lan ◽  
...  

Background. Gukang capsule (GKC) is a traditional Chinese medicine formulation which has been used extensively in the clinical treatment of bone fractures. However, the mechanisms underlying its effects on fracture healing remain unclear. Methods. In this study we used a rabbit radius fracture model, and we measured the serum content of bone alkaline phosphatase (ALP), calcium, and phosphorus and examined pathology of the fracture site as indicators of the fracture healing effects of GKC. SaOS-2 human osteosarcoma cells were used to measure (i) ALP activity, (ii) ornithine transcarbamylase (OTC), calcium, and mineralization levels, (iii) the expression of osteogenic-related genes, that is, runt-related transcription factor 2 (RUNX2), bone morphogenetic protein 2 (BMP2), collagen I (COL-I), osteopontin (OPN), OTC, and osterix (Osx), and (iv) the expression of key proteins in the Wnt/β-catenin and BMP/SMAD signaling pathways to study the mechanisms by which GKC promotes fracture healing. Results. We found that GKC effectively promotes radius fracture healing in rabbits and enhances ALP activity, increases OTC and calcium levels, and stimulates the formation of mineralized nodules in SaOS-2 cells. Moreover, COL-I, OTC, Osx, BMP2, and OPN expression levels were higher in SaOS-2 cells treated with GKC than control cells. GKC upregulates glycogen synthase kinase 3β (GSK3β) phosphorylation and Smad1/5 and β-catenin protein levels, thereby activating Wnt/β-catenin and BMP/Smad signaling pathways. Inhibitors of the Wnt/β-catenin and BMP/Smad signaling pathways (DKK1 and Noggin, respectively) suppress the osteogenic effects of GKC. Conclusions. GKC promotes fracture healing by activating the Wnt/β-catenin and BMP/Smad signaling pathways and increasing osteoprotegerin (OPG) secretion by osteoblasts (OBs), which prevents receptor activator of nuclear factor kappa B ligand (RANKL) binding to RANK.


2019 ◽  
Vol 32 (03) ◽  
pp. 257-268
Author(s):  
Hari Aithal ◽  
Prakash Kinjavdekar ◽  
Abhijit Pawde ◽  
Prasoon Dubey ◽  
Rohit Kumar ◽  
...  

Objective The aim of this study was to evaluate epoxy-pin external skeletal fixation technique for the treatment of open fractures in calves and foals. Study Design Twenty-eight calves and four foals (weighing 45–105 kg) with fractures distal to the stifle or elbow made the subject for the retrospective study. The pins (2.0–3.0-mm Kirschner wires, crossed at 60–90°) were fixed at least at two locations in both proximal and distal bone fragments as per the case situation. The pins in the same plane were bent (∼2 cm from the skin) towards the fracture site or joint and were joined using an adhesive tape (additional pins used when required) to make a temporary scaffold of connecting bars or rings. Thoroughly mixed epoxy putty was applied along the pin scaffold (the epoxy columns were 20–25 mm diameter) and allowed to set for 45 to 60 minutes. All animals were evaluated based on various clinical and radiographic observations made at regular intervals. Results The epoxy-pin fixation was easy to apply and provided stable fixation of bone as indicated by early weight bearing, and fracture healing within 45 to 60 days (17/32 cases). The functional recovery was good to very good in 14 animals and satisfactory in nine cases by 12 months after removal of the fixator. Conclusions The multiplanar epoxy-pin external skeletal fixation provides stable fixation of unstable open fractures distal to the stifle or elbow joint; hence, it can be used to treat a variety of fractures in calves and foals weighing up to approximately 100 kg, especially open infected fractures of lower limb, which are difficult to treat by conventional techniques.


2019 ◽  
Vol 40 (11) ◽  
pp. 1331-1337 ◽  
Author(s):  
Henrik C. Bäcker ◽  
J. Turner Vosseller

Background: Intramedullary implants have been used historically in long bone fractures with success. In recent years, a variety of intramedullary implants for the treatment of fibular fractures have been investigated. These various implants have not been assessed together in a cohesive manner. In this review, we assess implants used for intramedullary fixation of fibular fractures with respect to implant design and clinical results. Methods: A comprehensive systematic literature review for intramedullary implants in fibular fractures was performed. All publications that assessed intramedullary fibular implants were reviewed. In total, 11 different intramedullary nails were found. Clinical results obtained from these studies were reviewed. Results: The intramedullary implants used for fibular fracture fixation generally fell into one of 3 categories: an unlocked longitudinal strut, an implant roughly equivalent to a large screw, or a more traditionally locked intramedullary nail. Reported clinical results were generally good, although inconsistent outcome reporting greatly limited comparison between studies. Complication rates varied with the implants but were generally low. Conclusion: Intramedullary implants for fibular fracture stabilization have changed over the years to improve stability. Although clinical results are limited, data suggest that these implants are safe and can potentially approximate more traditional implants. Level of Evidence: Level II, systematic review.


2007 ◽  
Vol 19 (01) ◽  
pp. 37-46 ◽  
Author(s):  
Hasan H. Muratli ◽  
Feza Korkusuz ◽  
Petek Korkusuz ◽  
Ali Bicimoglu ◽  
Z. Sevim Ercan

It is assumed that bosentan, a non-selective ET-1 receptor antagonist, will enhance fracture healing. The aim of this prospective randomized controlled study was to investigate the effects of transcutaneous bosentan administration into diaphyseal bone fractures using radiology, histology, prostaglandin E2 (PGE2) and leukotrien C 4 (LTC4) activity measurements. A closed diaphyseal fracture was created in the hind limbs following intramedullary rod fixation of Guinea pigs. Bosentan was administred by repetitive weekly 0.1 μg transcutaneous injections into the fracture site. The effects of bosentan were evaluated by radiology and histology on weeks 1, 2 and 4, whereas prostaglandin E2 (PGE2)-like and leukotrien C 4 (LTC4)-like activity was assessed on weeks 1 and 2. The radiological degree of union (p = 0.001) at the fracture site and cortex-callus ratio (p = 0.02) was significantly better in the bosentan administered site at week 1 when compared to the control. Histology presented an initial stimulation of bone formation on weeks 1 and 2 in the experimental group. PGE2-like activity was significantly higher (p = 0.002) on week 1 and 2 in the bosentan-administered side. LTC4-like activity remained constant on week one and decreased on week two. Transcutaneous repetitive bosentan administration into the fracture site initially stimulated periosteal bone healing that resulted with extracellular matrix mineralization. The inflammatory mediators PGE2/LTC4 played a significant role in this process.


2020 ◽  
Vol 44 (1) ◽  
pp. 43-48
Author(s):  
Ante Muljačić ◽  
Matea Majstorović-Matejić ◽  
Marko Guberina ◽  
Ognjen Živković ◽  
Renata Poljak-Guberina

Total and bone alkaline phosphatase are indicators of bone formation, a process essential in bone healing. The aim of this study was to assess the relationship of both total and bone alkaline phosphatase with the course and features of healing in surgically treated long bone fractures as compared to the callus volume. In this study, total and bone alkaline phosphatase levels and the callus volume were measured in two patients with long bone fractures. Fracture healing was rapid in one patient and slow in the other. Depending on the healing outcome, on day 7 an increase in the case of slow healing and a decrease in the case of rapid healing was noted for both total and bone alkaline phosphatase. In the case of slow healing, the callus volume was significant whereas in the case of rapid healing the callus was almost invisible on day 7. This result indicates a possible prognostic significance of aforementioned clinical biochemical and radiographic parameters in the monitoring of long bone fracture healing.


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