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Screen-enrich-combine circulating system to prepare MSC/β-TCP for bone repair in fractures with depressed tibial plateau.
Chu, W, Wang, X, Gan, Y, Zhuang, Y, Shi, D, Liu, F, Sun, Y, Zhao, J, Tang, T, Dai, K
Regenerative medicine. 2019;(6):555-569
Abstract
Aim: To evaluate the clinical efficacy of mesenchymal stem cell/β-tricalcium phosphate composites (MSC/β-TCP) prepared with a screen-enrich-combine circulating system (SECCS) in patients with depressed tibial plateau fractures. Materials & methods: Bone defects in depressed tibial plateaus were filled with MSC/β-TCP (n = 16) or with β-TCP only (n = 23). Enrichment efficiency and effect of enrichment on cell viability were evaluated. Clinical results were assessed by imaging examination and Lysholm score. Results: SECCS effectively integrated MSCs with β-TCP. At 18 months postimplantation, new bone ratio was significantly higher in patients treated with MSC/β-TCP than in those treated with β-TCP only (p = 0.000). Patients with MSC/β-TCP implants had better functional recovery (p = 0.028). Conclusion: MSC/β-TCP prepared by SECCS were effective in the treatment of bone defects in patients with depressed tibial plateau fractures, promoted bone regeneration and improved joint function recovery.
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Octacalcium phosphate collagen composite facilitates bone regeneration of large mandibular bone defect in humans.
Kawai, T, Suzuki, O, Matsui, K, Tanuma, Y, Takahashi, T, Kamakura, S
Journal of tissue engineering and regenerative medicine. 2017;(5):1641-1647
Abstract
Recently it was reported that the implantation of octacalcium phosphate (OCP) and collagen composite (OCP-collagen) was effective at promoting bone healing in small bone defects after cystectomy in humans. In addition, OCP-collagen promoted bone regeneration in a critical-sized bone defect of a rodent or canine model. In this study, OCP-collagen was implanted into a human mandibular bone defect with a longer axis of approximately 40 mm, which was diagnosed as a residual cyst with apical periodontitis. The amount of OCP-collagen implanted was about five times greater than the amounts implanted in previous clinical cases. Postoperative wound healing was satisfactory and no infection or allergic reactions occurred. The OCP-collagen-treated lesion was gradually filled with radio-opaque figures, and the alveolar region occupied the whole of the bone defect 12 months after implantation. This study suggests that OCP-collagen could be a useful bone substitute material for repairing large bone defects in humans that might not heal spontaneously. Copyright © 2015 John Wiley & Sons, Ltd.
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Modifications to advanced Core decompression for treatment of Avascular necrosis of the femoral head.
Landgraeber, S, Warwas, S, Claßen, T, Jäger, M
BMC musculoskeletal disorders. 2017;(1):479
Abstract
BACKGROUND "Advanced Core Decompression" (ACD) is a new technique for treatment of osteonecrosis of the femoral head (ONFH) that includes removal of the necrotic tissue using a percutaneous expandable reamer followed by refilling of the drill hole and the defect with an injectable, hard-setting, composite calcium sulphate (CaSO4)-calcium phosphate (CaPO4) bone graft substitute. As autologous bone has been shown to be superior to all other types of bone grafts, the aim of the study is to present and evaluate a modified technique of ACD with impaction of autologous bone derived from the femoral neck into the necrotic defect. METHODS A cohort of patients with an average follow-up of 30.06 months (minimum 12 months) was evaluated for potential collapse of the femoral head and any reasons that led to replacement of the operated hip. Only patients in stages 2a to 2c according to the Steinberg classification were included in the study. RESULTS In 75.9% the treatment was successful with no collapse of the femoral head or conversion to a total hip replacement. Analysis of the results of the different subgroups showed that the success rate was 100% for stage 2a lesions and 84.6% respectively 61.5% for stages 2b and 2c lesions. CONCLUSIONS Previous studies with a comparable follow-up reported less favourable results for ACD without autologous bone. Especially in stages 2b and 2c the additional use of autologous bone has a positive effect. In comparison to other hip-preserving techniques, the modified ACD technique is a very promising and minimally invasive method for treatment of ONFH. TRIAL REGISTRATION German clinical trials register ( DRKS00011269 , retrospectively registered).
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Clinical performance of a highly porous beta-TCP as the grafting material for maxillary sinus augmentation.
Bettach, R, Guillaume, B, Taschieri, S, Del Fabbro, M
Implant dentistry. 2014;(3):357-64
Abstract
BACKGROUND Beta-tricalcium phosphate (β-TCP) is a synthetic bone substitute having high porosity and fast resorption. This retrospective study aimed at evaluating the effectiveness of an highly macroporous β-TCP for maxillary sinus floor augmentation. METHODS Twenty-seven consecutive patients (17 woman/10 men, mean age: 59.7 years) in 2 clinics underwent maxillary sinus augmentation by lateral approach using β-TCP as grafting material. Implant survival, prosthesis success, periimplant bone loss, oral hygiene level, soft tissue condition, complication occurrence, and patient satisfaction were assessed. RESULTS Thirty-one sinuses were successfully augmented. Sixty implants were placed. No sinus membrane perforations occurred. The mean follow-up after grafting was 39.3 ± 8.7 months (range, 22-52 months), and it was 30.5 ± 8.1 months (range, 15-43 months) after implant loading. No implants were lost. After 1 year of loading, marginal bone loss averaged -0.88 ± 0.46 mm (n = 54 implants). Mean full-mouth plaque and bleeding scores were 11.5% ± 4.8% and 3.5% ± 2.8%, respectively. No biological or mechanical complications were recorded. Patient satisfaction was very high. CONCLUSION Despite limited sample size and follow-up duration, highly macroporous β-TCP proved a valuable bone substitute for sinus augmentation, even when used alone.
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Tobramycin exposure from active calcium sulfate bone graft substitute.
Livio, F, Wahl, P, Csajka, C, Gautier, E, Buclin, T
BMC pharmacology & toxicology. 2014;:12
Abstract
BACKGROUND Bone graft substitute such as calcium sulfate are frequently used as carrier material for local antimicrobial therapy in orthopedic surgery. This study aimed to assess the systemic absorption and disposition of tobramycin in patients treated with a tobramycin-laden bone graft substitute (Osteoset® T). METHODS Nine blood samples were taken from 12 patients over 10 days after Osteoset® T surgical implantation. Tobramycin concentration was measured by fluorescence polarization. Population pharmacokinetic analysis was performed using NONMEM to assess the average value and variability (CV) of pharmacokinetic parameters. Bioavailability (F) was assessed by equating clearance (CL) with creatinine clearance (Cockcroft CLCr). Based on the final model, simulations with various doses and renal function levels were performed. (ClinicalTrials.gov number, NCT01938417). RESULTS The patients were 52 +/- 20 years old, their mean body weight was 73 +/- 17 kg and their mean CLCr was 119 +/- 55 mL/min. Either 10 g or 20 g Osteoset® T with 4% tobramycin sulfate was implanted in various sites. Concentration profiles remained low and consistent with absorption rate-limited first-order release, while showing important variability. With CL equated to CLCr, mean absorption rate constant (ka) was 0.06 h-1, F was 63% or 32% (CV 74%) for 10 and 20 g Osteoset® T respectively, and volume of distribution (V) was 16.6 L (CV 89%). Simulations predicted sustained high, potentially toxic concentrations with 10 g, 30 g and 50 g Osteoset® T for CLCr values below 10, 20 and 30 mL/min, respectively. CONCLUSIONS Osteoset® T does not raise toxicity concerns in subjects without significant renal failure. The risk/benefit ratio might turn unfavorable in case of severe renal failure, even after standard dose implantation.
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The use of beta-tricalcium phosphate and bone marrow aspirate as a bone graft substitute in posterior lumbar interbody fusion.
Thaler, M, Lechner, R, Gstöttner, M, Kobel, C, Bach, C
European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society. 2013;(5):1173-82
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Abstract
PURPOSE Due to the disadvantages of iliac crest bone and the poor bone quality of autograft gained from decompression surgery, alternative filling materials for posterior lumbar interbody fusion cages have been developed. β-Tricalcium phosphate is widely used in cages. However, data regarding the fusion rate of β-TCP assessed by computer tomography are currently not available. MATERIALS A prospective clinical trial involving 34 patients (56.7 years) was performed: 26 patients were treated with single-level, five patients double-level and three patients triple-level PLIF filled with β-TCP and bone marrow aspirate perfusion, and additional posterior pedicle screw fixation. Fusion was assessed by CT and X-rays 1 year after surgery using a validated fusion scale published previously. Functional status was evaluated with the visual analogue scale and the Oswestry Disability Index before and 1 year after surgery. RESULTS Forty-five levels in 34 patients were evaluated by CT and X-ray with a follow-up period of at least 1 year. Clinically, the average ODI and VAS for leg and back scores improved significantly (P < 0.001). CT assessment revealed solid fusion in 12 levels (26.67%) and indeterminate fusion in 15 levels (34.09%). Inadequate fusion (non-union) was detected in 17 levels (38.63%). CONCLUSION The technique of PLIF using β-TCP yielded a good clinical outcome 1 year after surgery, however, a high rate of pseudoarthrosis was found in this series therefore, we do not recommend β-TCP as a bone graft substitute using the PLIF technique.
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A novel approach revealing the effect of a collagenous membrane on osteoconduction in maxillary sinus floor elevation with β-tricalcium phosphate.
Schulten, EA, Prins, HJ, Overman, JR, Helder, MN, ten Bruggenkate, CM, Klein-Nulend, J
European cells & materials. 2013;:215-28
Abstract
Calcium phosphates are used in maxillary sinus floor elevation (MSFE) procedures to increase bone height prior to dental implant placement. Whether a collagenous barrier membrane coverage of the lateral window affects bone formation within a bone substitute augmentation is currently an important matter of debate, since its benefit has not been irrefutably proven. Therefore, in this clinical study twelve patients underwent an MSFE procedure with β-tricalcium phosphate (β-TCP). The lateral window was either left uncovered, or covered with a resorbable collagenous barrier membrane. After a 6-months healing period, bone biopsies were retrieved during implant placement. Consecutive 1 mm regions of interest of these biopsies were assessed for bone formation, resorption parameters, as well as bone architecture using histology, histomorphometry and micro-computed tomography. Comparable outcomes between the groups with and without membrane were observed regarding osteoconduction rate, bone and graft volume, osteoclast number and structural parameters of newly formed bone per region of interest. However, osteoid volume in grafted maxillary sinus floors without membrane was significantly higher than with membrane. In conclusion, our results - obtained with a novel method employed using 1 mm regions of interest - demonstrate that the clinical application of a bioresorbable collagenous barrier membrane covering the lateral window, after an MSFE procedure with β-TCP, was not beneficial for bone regeneration and even decreased osteoid production which might lead to diminished bone formation in the long run.
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Silicate-substituted calcium phosphate as a bone graft substitute in surgery for adolescent idiopathic scoliosis.
Lerner, T, Liljenqvist, U
European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society. 2013;(Suppl 2):S185-94
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Abstract
STUDY DESIGN AND OBJECTIVE The purpose of this prospective clinical study is to evaluate the clinical and radiographic outcomes using a silicate-substituted calcium phosphate (Si-CaP) as a bone graft substitute in surgery for adolescent idiopathic scoliosis (AIS). In posterior corrective surgery for AIS, harvesting autologous bone from the iliac crest still represents the gold standard to augment the local bone graft though it is comparatively invasive and associated with donor site morbidity. Si-CaP enriched with bone marrow aspirate (BMA) might be an appropriate bone graft extender to overcome these difficulties. METHODS Eighteen female and three male patients with AIS who underwent corrective posterior instrumentation were observed clinically and radiographically for a minimum of 24 months. In all cases, 20-40 ml Si-CaP granules (ACTIFUSE) mixed with BMA from vertebral bodies was used to extend the local bone graft. Fusion was assessed by standardized conventional radiographs regarding loss of correction and implant failure. Clinical outcome was evaluated with use of the Scoliosis Research Society-22 patient Questionnaire (SRS-22) and a Visual Analog Scale (VAS) for back pain. RESULTS Cobb angle of major curves averaged 63° preoperatively, 22° after surgery, and 24° at final follow-up, with a maximum loss of correction of 7° recorded after 4 months. No adverse effects related to the study material had been observed. In all patients, there was no evidence of implant failure, and formation of an increasingly densifying 'fusion mass' was visible, as assessed by conventional radiography. VAS score for back pain averaged 1.7 before surgery, 2.3 at discharge, and 1.5 at final follow-up. Outcome assessment using the SRS-22 revealed a significantly enhanced overall health-related quality of life (84 vs. 74 % before surgery; P = 0.0005) due to a significant improvement of the domains 'self image' (77 vs. 59 %; P = 0.0002) and 'pain' (88 vs. 80 %; P = 0.02). Patients' management satisfaction averaged 93 %. CONCLUSIONS Si-CaP augmented with BMA from vertebral bodies seems to prove an effective, safe, and easy to handle bone graft extender in scoliosis surgery and thus a suitable alternative to bone harvesting procedures.
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Pore geometry regulates early stage human bone marrow cell tissue formation and organisation.
Knychala, J, Bouropoulos, N, Catt, CJ, Katsamenis, OL, Please, CP, Sengers, BG
Annals of biomedical engineering. 2013;(5):917-30
Abstract
Porous architecture has a dramatic effect on tissue formation in porous biomaterials used in regenerative medicine. However, the wide variety of 3D structures used indicates there is a clear need for the optimal design of pore architecture to maximize tissue formation and ingrowth. Thus, the aim of this study was to characterize initial tissue growth solely as a function of pore geometry. We used an in vitro system with well-defined open pore slots of varying width, providing a 3D environment for neo-tissue formation while minimizing nutrient limitations. Results demonstrated that initial tissue formation was strongly influenced by pore geometry. Both velocity of tissue invasion and area of tissue formed increased as pores became narrower. This is associated with distinct patterns of actin organisation and alignment depending on pore width, indicating the role of active cell generated forces. A mathematical model based on curvature driven growth successfully predicted both shape of invasion front and constant rate of growth, which increased for narrower pores as seen in experiments. Our results provide further evidence for a front based, curvature driven growth mechanism depending on pore geometry and tissue organisation, which could provide important clues for 3D scaffold design.
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Osteoporotic vertebral compression fracture augmentation by injectable partly resorbable ceramic bone substitute (Cerament™|SPINESUPPORT): a prospective nonrandomized study.
Masala, S, Nano, G, Marcia, S, Muto, M, Fucci, FP, Simonetti, G
Neuroradiology. 2012;(11):1245-51
Abstract
INTRODUCTION This study aimed to evaluate long-term stabilizing healing effectiveness and influence on adjacent intact vertebral bodies of a new injectable partly resorbable calcium sulfate (60 wt.%)/hydroxyapatite (40 wt.%) bone substitute employed in vertebral augmentation of osteoporotic collapses. METHODS From April 2009 to April 2011, 80 patients underwent vertebral augmentation. Patient enrolment criteria are as follows: age more than 20 years; symptomatic osteoporotic vertebral compression fracture from low energy trauma encompassing level T5 to L1 and classified as A1.1 to A1.2 according to the AO classification system; vertebral height compression within 0-75% compared to the posterior (dorsal) wall; client history confirming the age of the compression fracture to be within at least 4 weeks; and patients who are able to understand the procedure and participate in the study. Preoperative and postoperative imaging studies consisted of computed tomography, plain X-ray, dual X-ray absorptiometry scanning, and magnetic resonance. Pain intensity has been evaluated by an 11-point visual analog scale (VAS), and physical and quality of life compromise assessments have been evaluated by Oswestry Disability Questionnaire (ODI). All procedures have been performed fluoroscopically guided by left unilateral approach under local anesthesia and mild sedation. RESULTS VAS-based pain trend over 12-month follow-up has shown a statistical significant (p < 0.001) decrease, starting from 7.68 (SD 1.83) preoperatively with an immediate first day decrease at 3.51 (SD 2.16) and 0.96 (SD 0.93) at 12 months. The ODI score dropped significantly from 54.78% to 20.12% at 6 months. None device-related complication has been reported. In no case, a new incidental adjacent fracture has been reported. CONCLUSION Data show how this injectable partly resorbable ceramic cement could be a nontoxic and lower stiffness alternative to polymethylmethacrylate for immediate and long-term stabilization of osteoporotic collapsed vertebral bodies.