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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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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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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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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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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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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 level-1 pilot study to evaluate of ultraporous beta-tricalcium phosphate as a graft extender in the posterior correction of adolescent idiopathic scoliosis.
Lerner, T, Bullmann, V, Schulte, TL, Schneider, M, 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. 2009;(2):170-9
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The objective of this study is to compare the clinical and radiographic results of ultraporous beta-tricalcium phosphate (beta-TCP) versus autogenous iliac crest bone graft (ICBG), through prospective randomized pilot study (EBM-Level 1), as graft extenders in scoliosis surgery. In the posterior correction of scoliosis, local bone resected as part of the procedure is used as the base bone graft material. Supplemental grafting from the iliac crest is considered the gold-standard in posterior spinal fusion. However, autograft is not available in unlimited quantities, and bone harvesting is a source of significant morbidity. Ultraporous beta-TCP might be a substitute for ICBG in these patients and thus eliminate donor site morbidity. A total of 40 patients with adolescent idiopathic scoliosis (AIS) were randomized into two treatment groups and underwent corrective posterior instrumentation. In 20 patients, ICBG harvesting was performed whereas the other half received beta-TCP (VITOSS) to augment the local bone graft. If thoracoplasty was performed, the resected rib bone was added in both groups. Patients were observed clinically and radiographically for a minimum of 20 months postoperatively, with a mean follow-up of 4 years. Overall pain and pain specific to the back and donor site were assessed using a visual analog scale (VAS). As a result, both groups were comparable with respect to the age at the time of surgery, gender ratio, preoperative deformity, and hence length of instrumentation. There was no significant difference in blood loss and operative time. In nine patients of the beta-TCP group and eight patients of the ICBG group, thoracoplasty was performed resulting in a rib graft of on average 7.9 g in both groups. Average curve correction was 61.7% in the beta-TCP group and 61.2% in the ICBG group at hospital discharge (P=0.313) and 57.2 and 54.3%, respectively, at follow-up (P=0.109). Loss of curve correction amounted on average 2.6 degrees in the beta-TCP group and 4.2 degrees in the comparison group (P=0.033). In the ICBG group, four patients still reported donor site pain of on average 2/10 on the VAS at last follow-up. One patient in the beta-TCP group was diagnosed with a pseudarthrosis at the caudal end of the instrumentation. Revision surgery demonstrated solid bone formation directly above the pseudarthrosis with no histological evidence of beta-TCP in the biopsy taken. In conclusion, the use of beta-TCP instead of ICBG as extenders of local bone graft yielded equivalent results in the posterior correction of AIS. The promising early results of this pilot study support that beta-TCP appears to be an effective bone substitute in scoliosis surgery avoiding harvesting of pelvic bone and the associated morbidity.
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The safety and efficacy of an injectable bone substitute in dental sockets demonstrated in a human clinical trial.
Weiss, P, Layrolle, P, Clergeau, LP, Enckel, B, Pilet, P, Amouriq, Y, Daculsi, G, Giumelli, B
Biomaterials. 2007;(22):3295-305
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This study is the first report of a clinical evaluation of an injectable bone substitute (IBS). This IBS was prepared by suspending biphasic calcium phosphate (BCP) particles with diameters ranging between 80 and 200 microm in a water-soluble cellulose polymer carrier phase. It was used for filling bone defects after tooth extractions in 11 patients. The first objective of the study was to investigate the safety of the filler material. The second objective was to investigate the efficacy of the material for filling human tooth sockets and preventing alveolar bone loss. Radiographic density measurements of the surgical sites gradually increased to those of the surrounding host bone. Three years after surgery, small biopsies of the implanted areas were harvested and analyzed by using micro-computed tomography, non-decalcified histology and histomorphometry. The BCP granules appeared in direct contact with mineralized bone tissue, thereby supporting bone growth. A gradual substitution of the filler by bone tissue was observed thus preserving the height of the alveolar bone crest.