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1.
The Titanium-coated PEEK Cage Maintains Better Bone Fusion With the Endplate Than the PEEK Cage 6 Months After PLIF Surgery: A Multicenter, Prospective, Randomized Study.
Hasegawa, T, Ushirozako, H, Shigeto, E, Ohba, T, Oba, H, Mukaiyama, K, Shimizu, S, Yamato, Y, Ide, K, Shibata, Y, et al
Spine. 2020;(15):E892-E902
Abstract
STUDY DESIGN A multicenter, randomized, open-label, parallel-group trial. OBJECTIVE To investigate interbody bone fusion rates in titanium-coated polyetheretherketone (TiPEEK) and polyetheretherketone (PEEK) cages after posterior lumbar interbody fusion (PLIF) surgery. SUMMARY OF BACKGROUND DATA Previous clinical studies have not revealed any significant difference in bone fusion rates between TiPEEK and PEEK cages. METHODS During one-level PLIF surgery, 149 patients (84 men, 65 women, mean age 67 yr) were randomly allocated to use either a TiPEEK cage (n = 69) or PEEK cage (n = 80). Blinded radiographic evaluations were performed using computed tomography and assessed by modified intention-to-treat analysis in 149 cases and per-protocol analysis in 143 cases who were followed for 12 months. Clinical outcomes were assessed using the Japanese Orthopaedic Association Back Pain Evaluation Questionnaire and the Oswestry Disability Index. RESULTS The interbody union rate at 12 months after surgery was 45% owing to a very strict definition of bone fusion. The rates of bone fusion were significantly higher at 4 and 6 months after surgery in the TiPEEK group than in the PEEK group in the unadjusted modified intention-to-treat analysis and were significantly higher at 6 months in the unadjusted per-protocol analysis. Binary logistic regression analysis adjusted for sex, age, body mass index, bone mineral density, and surgical level showed that using a TiPEEK cage (odds ratio, 2.27; 95% confidence interval: 1.09-4.74; P = 0.03) was independently associated with bone fusion at 6 months after surgery. Japanese Orthopaedic Association Back Pain Evaluation Questionnaire and Oswestry Disability Index results improved postoperatively in both groups. CONCLUSION Using the TiPEEK cage for PLIF enabled the maintenance of better bone fusion to the endplate than using the PEEK cage at 6 months after the surgery. Our findings suggest the possibility of an earlier return to rigorous work or sports by the use of TiPEEK cage. LEVEL OF EVIDENCE 1.
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2.
Recombinant Human Platelet-Derived Growth Factor BB in Combination With a Beta-Tricalcium Phosphate (rhPDGF-BB/β-TCP)-Collagen Matrix as an Alternative to Autograft.
Daniels, TR, Anderson, J, Swords, MP, Maislin, G, Donahue, R, Pinsker, E, Quiton, JD
Foot & ankle international. 2019;(9):1068-1078
Abstract
BACKGROUND Joint arthrodesis often employs autograft to promote union; graft harvesting can lead to perioperative morbidity. A Canadian randomized controlled trial (RCT) demonstrated that recombinant human platelet-derived growth factor BB homodimer (rhPDGF-BB) combined with beta-tricalcium phosphate (β-TCP)-collagen was a safe, effective alternative to autograft. This multicenter North American RCT compared the safety and efficacy of rhPDGF-BB/β-TCP-collagen with autograft for ankle and hindfoot fusion. Subclassification using propensity scores (PS) incorporated patients from previous trials for enhanced statistical power for noninferiority testing and broader review of treatments. METHODS Patients requiring ankle or hindfoot arthrodesis and supplemental bone graft were treated with rhPDGF-BB/β-TCP-collagen (n = 69) or autograft (n = 35). Outcomes included joint fusion on computed tomography (24 weeks), clinical healing status, visual analog scale (VAS) pain, Short-Form 12 (SF-12), American Orthopaedic Foot & Ankle Society (AOFAS) Ankle-Hindfoot Scale, and Foot Function Index (FFI) scores over 52 weeks. PS methodology addressed potential selection bias arising from pooling data among these patients and 2 previous RCTs with similar inclusion criteria, surgical techniques, graft harvest techniques, and outcomes. All 132 rhPDGF-BB/β-TCP-collagen-treated patients and 167 of 189 candidate autograft-treated controls were selected for comparison by an independent statistician blinded to outcomes. RESULTS In the PS subclassification, 68.1% treatment patients and 68.4% controls achieved >50% osseous bridging at fusion sites. Clinical healing status was achieved in 84.8% of treated patients and 90.7% of controls at 52 weeks. Clinical, functional, and quality of life results demonstrated noninferiority of rhPDGF-BB/β-TCP-collagen to autograft. Safety-related outcomes were equivalent. CONCLUSION PS subclassification analysis of 3 RCTs demonstrated that rhPDGF-BB/β-TCP-collagen was as effective as autograft for ankle and hindfoot fusions, with less pain and morbidity than treatment with autograft. LEVEL OF EVIDENCE Level I, prospective randomized study.
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3.
Does the association of blood-derived growth factors to nanostructured carbonated hydroxyapatite contributes to the maxillary sinus floor elevation? A randomized clinical trial.
de Almeida Barros Mourão, CF, Lourenço, ES, Nascimento, JRB, Machado, RCM, Rossi, AM, Leite, PEC, Granjeiro, JM, Alves, GG, Calasans-Maia, MD
Clinical oral investigations. 2019;(1):369-379
Abstract
OBJECTIVE The combination of calcium phosphate with blood-derived growth factors (BDGF) has been widely used in bone regeneration procedures although its benefits are still unclear. The purpose of this study was to evaluate whether or not BDGF improves the efficacy of a modified carbonated calcium phosphate biomaterial in sinus floor augmentation. MATERIAL AND METHODS Ten patients underwent 20 sinus floor augmentation procedures using nanostructured carbonated hydroxyapatite (cHA) microspheres alone or associated with BDGF in a randomized controlled clinical trial. The in vitro release of growth factors was assessed by an elution assay. Bone grafts were randomly implanted in the right and left maxillary sinuses of each participant, associated either with a 0.9% saline solution or BDGF. Bone gain was evaluated through cone beam tomography after 180 days. RESULTS Nine women and one man composed the sample. The blood-derived concentrates were able to release high levels of growth factors and cytokines. A significant clinical advantage was observed in the use of the BDGF after fibrin polymerization around the biomaterial microspheres, optimizing the surgical procedures, thereby reducing the time and displacement, and improving the adaptation of the biomaterial in the maxillary sinus. No synergistic effect was observed in bone formation when cHA was associated with BDGF (p > 0.05). CONCLUSION Equivalent new bone formation was observed for cHA in the presence or absence of the BDGF concentrate in bilateral sinus floor elevation after 6 months. Blood-derived growth factors did not improve bone repair when associated with calcium phosphate in sinus lift procedures.
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4.
Randomized, Double-Blinded, Sham-Controlled, Split-Hand Trial Evaluating the Safety and Efficacy of Triamcinolone Acetate Injection After Calcium Hydroxylapatite Volume Restoration of the Dorsal Hand.
Wu, DC, Goldman, MP
Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.]. 2018;(4):534-541
Abstract
BACKGROUND Calcium hydroxylapatite (CaHA) is currently the only FDA-approved soft-tissue filler indicated for augmentation of the dorsal hand. Although the treatment is generally safe and effective, adverse side effects such as swelling and edema postinjection are common and can sometimes be debilitating. OBJECTIVE In this study, the authors explore the utility of triamcinolone acetate coinjection with CaHA to the dorsal hands to mitigate adverse effects and improve patient experience. PATIENTS AND METHODS After obtaining informed consent, 20 subjects were enrolled in this double-blind, randomized, split-hand, sham-controlled clinical trial. Subject hands were randomized to receive either CaHA with triamcinolone acetate or CaHA with sham saline coinjection. Follow-up evaluations were performed by a blinded investigator at Days 7, 14, 30, 90, 180, 270, and 360 and consisted of the validated Merz Hand Grading Scale and assessments of erythema, edema, modules, bruising, and skin atrophy. Subjects also kept a daily diary for the first 30 days postinjection documenting bruising, itching, pain, redness, swelling, difficulty in performing activities with hands, and sensory alteration in hands. RESULTS There were no significant differences in treatment efficacy between the 2 groups. Post-treatment swelling was significantly reduced between Days 6 and 19 in the triamcinolone acetate coinjection group. CONCLUSION The addition of triamcinolone acetate coinjection with CaHA for dorsal hand augmentation did not negatively impact treatment efficacy but significantly reduced adverse side effects. This strategy represents a safe and effective way to improve patient experience and treatment tolerability.
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5.
Monophasic ß-TCP vs. biphasic HA/ß-TCP in two-stage sinus floor augmentation procedures - a prospective randomized clinical trial.
Jelusic, D, Zirk, ML, Fienitz, T, Plancak, D, Puhar, I, Rothamel, D
Clinical oral implants research. 2017;(10):e175-e183
Abstract
OBJECTIVES To compare a monophasic (100% ß-TCP) and a biphasic (60% HA and 40% ß-TCP) bone substitute material (BSM) regarding biocompatibility, osteoconductivity and implant stability using histological, radiological and resonance frequency analysis. MATERIAL AND METHODS Sixty-seven sinus floor elevations were performed in 60 patients. One patient group (monophasic bone substitute [MBS], 30 patients, 32 sinuses) was augmented by the use of the monophasic material (Bioresorb® , Sybron Implant Solutions, Bremen, Germany), while the second group (biphasic bone substitute (BBS), 30 patients, 35 sinuses) received a biphasic material (Maxresorb® , Botiss Biomaterials, Berlin, Germany). Cone beam CT images were taken immediately after augmentation and prior to implant placement after 6 months. Trephines were harvested, while the implant bed was prepared. Resonance frequency analysis was performed immediately after implant placement and 6 months later. Descriptive analysis was performed on all augmented sinus (n = 67). For statistical comparison of the groups, one sinus of each bilaterally treated patient was randomly excluded, resulting in 30 sinuses grafted with MBS and 30 sinuses grafted with BBS (n = 60). RESULTS Histomorphometrical analysis of all sinuses displayed comparable results for both groups regarding new bone matrix (MBS 36.16 ± 19.37%, BBS 38.42 ± 12.61%), residual BSM (MBS 30.26 ± 11.7%, BBS 32.66 ± 12.57%) and non-mineralized tissue (MBS 34.29 ± 18.32%, BBS 28.92 ± 15.04) %) (P > 0.05, respectively). Radiological volume of BBS was significantly more stable (volume loss of 22.2% for MBS, 6.66% for BBS; P < 0.001), and homogeneity of the graft after 6 months was higher for BBS than that for MBS (P < 0.05). Resonance frequency analysis endorsed a higher implant stability quotient for BBS after 6 months than that for MBS (MBS 78.31 ± 5.81, BBS 80.42 ± 6.31; P < 0.05, Mann-Whitney U-test, respectively). CONCLUSION Both monophasic and biphasic materials show good biocompatibility and osteoconductivity with satisfactory support on implant stability. BBS remains more stable in terms of volume maintenance and radiological graft homogeneity after a healing period of 6 months.
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6.
Vascularized bone grafting fixed by biodegradable magnesium screw for treating osteonecrosis of the femoral head.
Zhao, D, Huang, S, Lu, F, Wang, B, Yang, L, Qin, L, Yang, K, Li, Y, Li, W, Wang, W, et al
Biomaterials. 2016;:84-92
Abstract
Hip-preserving surgery with vascularized bone graft implantation has been widely practiced in treating osteonecrosis of the femoral head (ONFH). However, the current approach presents a drawback, in which the implanted bone graft without screw fixation may slip or exhibit a certain degree of displacement postoperatively. This study was designed to investigate the application potential of biodegradable magnesium (Mg) screws for the fixation of vascularized bone graft in ONFH patients. Forty-eight patients were randomly divided into two groups: the Mg screw group (vascularized bone grafting fixed by Mg screws) and the control group (vascularized bone grafting without fixation). During 12 month follow-up period after surgery, treatment outcomes in patients were assessed by multiple imaging techniques including x-ray and computed tomography (CT) scanning as well as functional recovery Harris hip score (HHS). The temporal changes in serum levels of Mg, Ca, and P as well as in vivo degradation rate of Mg screws were determined. The absence of potential adverse effects induced by degradation products from Mg screws on surrounding bone tissue was validated via CT imaging analysis. HHS was significantly improved in the Mg screw group when compared to the control group. X-ray imaging analysis showed that the screw shape did not show significant alteration due to the diameter of Mg screws measured with approximate 25% reduction within 12 months post-surgically. The postoperative serum levels of Ca, Mg, and P, which are relevant for liver and kidney function, were all within normal physiological range in all patients of both groups. The use of biodegradable Mg screws may provide a promising bone graft-screw fixation route in treating ONFH and present considerable potential for orthopedic applications.
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7.
The use of a biocompatible cement in endodontic surgery. A randomized clinical trial 1.
Silva, SR, Silva, JD, Schnaider, TB, Veiga, DF, Novo, NF, Mesquita, M, Ferreira, LM
Acta cirurgica brasileira. 2016;(6):422-7
Abstract
PURPOSE To evaluate the clinical applicability of Pozzolana Biologic Silva cement (PBS(r)) in endodontic surgery. METHODS Persistent apical periodontitis was diagnosed in 30 teeth of 12 patients by cone-beam computed tomography (CT). All patients had 2 or 4 affected teeth and underwent endodontic surgery with root-end filling. Patients with 2 affected teeth had one tooth (control) treated with mineral trioxide aggregate (MTA-Angelus(r)) as a root-end filling material, and the other tooth treated with PBS (experiment). When the patient had four affected teeth, two of them were treated with MTA and two with PBS. Six months after surgery, all patients were assessed by CT scan. Between-group comparisons of measurements were performed using the Wilcoxon test. RESULTS Periradicular tissue regeneration was observed in all cases. Significant within-group differences in long axes of the lesion were found in the bucco-palatal direction (PBS group, p=0.0012; MTA group, p=0.024) and coronal-apical direction (PBS group, p=0.0007; MTA group, p=0.0015) between pre- and postoperative measurements. CONCLUSIONS Pozzolana Biologic Silva cement can be used in the treatment of persistent periradicular lesions. The clinical use of PBS as a root-end filling material may be an alternative to MTA. PBS has additives, which provide enhanced strength.
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8.
One-year follow-up results from AUGMENT-HF: a multicentre randomized controlled clinical trial of the efficacy of left ventricular augmentation with Algisyl in the treatment of heart failure.
Mann, DL, Lee, RJ, Coats, AJ, Neagoe, G, Dragomir, D, Pusineri, E, Piredda, M, Bettari, L, Kirwan, BA, Dowling, R, et al
European journal of heart failure. 2016;(3):314-25
Abstract
AIMS: AUGMENT-HF was an international, multicentre, prospective, open-label, randomized, controlled evaluation testing the hypothesis that Algisyl (injectable calcium alginate hydrogel) is superior to standard medical therapy (SMT) for improving functional capacity and clinical outcomes in patients with advanced heart failure (HF). We previously reported results following 6 months of follow-up. This report presents the results from 1 year of extended follow up for this clinical trial. METHODS AND RESULTS We enrolled 78 patients with advanced HF, randomized (1:1), to Algisyl with SMT or SMT alone as previously reported. Patient inclusion criteria were LVEF ≤35%, peak VO2 of 9.0-14.5 mL/min/kg and LV end-diastolic diameter (LVEDD) index 30-40 mm/m(2) (LVEDD/body surface area). Patients must have been on stable, evidence-based therapy for HF. A total of 58 patients, mean age 62.3 ± 9.6 years, with ischaemic (57.7%) or non-ischaemic (42.3%) HF completed 12 months of follow-up. Treatment with Algisyl was associated with improved peak VO2 at 12 months; treatment effect vs. control of +2.10 mL/kg/min (95% confidence interval 0.96-3.24, P < 0.001). Statistically significant improvements were observed for VO2 at anaerobic threshold, 6-min walk test distance, and NYHA functional class (all P < 0.001). Through 12 months of follow-up there were 4 (10.5%) deaths in the control group and 9 (22.5%) deaths in the Algisyl group. CONCLUSIONS Algisyl in addition to SMT was more effective than SMT alone for providing sustained 1-year benefits in exercise capacity, symptoms, and clinical status for patients with advanced HF. These data support larger clinical evaluations of this novel therapy.
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9.
Comparison of the PEEK cage and an autologous cage made from the lumbar spinous process and laminae in posterior lumbar interbody fusion.
Lin, B, Yu, H, Chen, Z, Huang, Z, Zhang, W
BMC musculoskeletal disorders. 2016;(1):374
Abstract
BACKGROUND A prospective cohort study was performed to evaluate the clinical and radiological outcomes following posterior lumbar interbody fusion (PLIF) in patients treated with a PEEK cage compared to those treated with an autologous cage using the lumbar spinous process and laminae (ACSP). METHODS Sixty-nine consecutive patients with lumbar degenerative disc disease were randomly assigned to either a PEEK cage (group A, n = 34) or an ACSP (group B, n = 35). Monosegmental PLIF was performed in all patients. Mean lumbar lordosis, mean disc height, visual analog scale (VAS) scores, functional outcomes, fusion rates and complication rates were recorded and compared. The patients were followed postoperatively for a minimum of 2 years. RESULTS Successful radiographic fusion was documented in all patients. No flexion-extension hypermobility or pedicle screw loosening or breakage occurred during the follow-up period. No significant difference existed between the 2 groups when comparing the mean lumbar lordosis, mean disc height, visual analog scale (VAS) scores, functional outcomes, fusion rates or complication rates. Overall satisfactory results were achieved in both groups. CONCLUSIONS The results suggest that the ACSP appears to be equally as safe and effective as the PEEK cage. TRIAL REGISTRATION ISRCTN25558534 . Retrospectively registered 16/02/2016.
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10.
Single versus double flap approach in periodontal regenerative treatment.
Schincaglia, GP, Hebert, E, Farina, R, Simonelli, A, Trombelli, L
Journal of clinical periodontology. 2015;(6):557-66
Abstract
AIM: to compare the outcomes of a regenerative strategy based on recombinant human platelet-derived growth factor-BB (rhPDGF-BB, 0.3 mg/ml) and β-tricalcium phosphate (β-TCP) in the treatment of intraosseous defects accessed with the Single Flap Approach (SFA) versus Double Flap Approach based on papilla preservation techniques (DFA). MATERIALS AND METHODS Fifteen and 13 defects, randomly assigned to SFA or DFA, respectively, were grafted with rhPDGF-BB + β-TCP. Probing parameters were assessed before and 6 months after surgery. Pain (VAS(pain)) was self-reported using a visual analogue scale. RESULTS Twelve SFA sites and DFA 6 sites showed complete flap closure at 2 weeks post-surgery. No significant differences in 6-month changes in probing parameters and radiographic defect fill were found between groups. Significantly lower VAS(pain) was observed in SFA group compared to DFA group at day +1, +2 and +6. A significantly greater number of analgesics were consumed in the DFA group compared to the SFA group at day +1. CONCLUSIONS When combined with rhPDGF-BB and β-TCP, the SFA may result in similar clinical outcomes, better quality of early wound healing, and lower pain and consumption of analgesics during the first postoperative days compared to the DFA.