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Multicenter Pilot Study to Assess a Biphasic Calcium Phosphate Implant for Functional and Aesthetic Septorhinoplasty.
de Gabory, L, Boudard, P, Bessède, JP, Maillard, A, Lacomme, S, Gontier, E, Durand, M, Fricain, JC, Bénard, A, Bordenave, L
Facial plastic surgery & aesthetic medicine. 2021;(5):321-329
Abstract
Importance: A validated biomaterial would have several medical advantages in septorhinoplasties requiring a large-volume graft such as avoiding donor site morbidity, making ambulatory surgery possible, and reducing surgical costs. Objective: To assess the safety and efficacy of a ceramic to treat saddle and crooked noses. The main endpoint was the biocompatibility of the implant. The secondary endpoint was its functional and aesthetic efficacy. Design, Setting, and Participants: The nasal septum (NASEPT) study is a pilot multicenter noncomparative prospective phase IIa clinical trial. The biomaterial tested was a biphasic calcium phosphate implant composed of 75% hydroxyapatite and 25% beta tri calcium phosphate. This versatile material can be used to replace septal skeleton when it is absent or nonusable. We included 25 patients with a multifractured osseous and cartilaginous framework after several traumas or surgeries. The implant placement technique was identical to an extracorporeal septoplasty through the external approach. Main Outcomes and Measures: The primary endpoint was the occurrence of expected adverse and severe adverse events. The secondary endpoints were clinical functional and aesthetic results and histological microscopic modifications. Results: Any extrusion, infection, pain, and epistaxis were observed. All implants were placed in a sagittal, straight, and solid position without extralobular depression. Comparisons between pre- and postoperative symptoms showed that nasal comfort (p < 10-4) and quality of life (p < 10-4) were dramatically improved in all patients. The nasolabial angle (p = 0.047) and the columellar projection (p = 0.024) were improved after surgery. Histological data showed little submucosal inflammation at 6 months with well-differentiated epithelium. The mean follow-up was 23 months: three patients underwent revision surgery for functional or aesthetic details and four implants were removed (16%) owing to a foreign body reaction between 17 and 74 months. Conclusion and Relevance: The NASEPT implant meets functional and aesthetic requirements in complex septorhinoplasties but its long-term biocompatibility needs to be improved. It could potentially avoid donor site morbidity.
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The formation of perianchor fluid associated with various suture anchors used in rotator cuff repair: all-suture, polyetheretherketone, and biocomposite anchors.
Kim, SH, Yang, SH, Rhee, SM, Lee, KJ, Kim, HS, Oh, JH
The bone & joint journal. 2019;(12):1506-1511
Abstract
AIMS: The aim of this study was to compare the osseous reactions elicited by all-suture, polyetheretherketone (PEEK), and two different biodegradable anchors used during rotator cuff repair. PATIENTS AND METHODS Transosseous-equivalent rotator cuff repair was performed in 73 patients. The patients were divided into two groups, in both of which two different medial-row anchors were used. In group 1, anchor A comprised 30% β-tricalcium phosphate (TCP) + 70% fast-absorbing poly lactic-co-glycolic acid copolymer (85% polylactic acid enantiomers + 15% polyglycolic acid) and anchor B comprised all-sutures. In group 2, anchor C comprised 23% micro β-TCP + 77% polylactic acid enantiomers and anchor D comprised PEEK polymer. There were 37 patients in group 1 and 36 patients in group 2. The presence and severity of fluid collection around anchors and healing of the rotator cuff were assessed using MRI scans, approximately one year postoperatively. The severity of the collection was graded as 0 (no perianchor fluid signal), 1 (minimal perianchor fluid), 2 (local collection of fluid), 3 (fluid collection around the whole length of the anchor but of a diameter less than twice the anchor diameter), or 4 (fluid collection around the whole length of the anchor and of a diameter greater than twice the anchor diameter). RESULTS A perianchor fluid signal was seen in three patients (8.1%) with anchor A, four (10.8%) with anchor B, 15 (41.7%) with anchor C, and 15 (41.7%) with anchor D. The severity of the collection around anchor was grade 2:1:0:0 for anchor A, grade 2:2:0:0 for anchor B, grade 12:2:0:1 for anchor C, and grade 11:3:0:1 for anchor D (grade 1:2:3:4, respectively). The prevalence and severity of fluid formation was not significantly different between anchors A and B, and anchors C and D. However, on intergroup analysis, there were significant differences for the prevalence and severity of fluid formation between anchors in group 1 and group 2. The prevalence of failure to heal was not significant in group 1 (seven, 18.9%) or group 2 (nine, 25.0%). There was no relationship between the presence of perianchor fluid and each type of anchor, and the integrity of the rotator cuff repair, in either group. CONCLUSION Despite the nonabsorbable nature of all-suture and PEEK anchors, all-suture anchors produced less osseous reaction after rotator cuff repair. In deciding which kind of anchor to use, consideration should be given not only to the strength of the initial fixation, but also to the postoperative biological reaction. Cite this article: Bone Joint J 2019;101-B:1506-1511.
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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.
Gómez-Barrena, E, Rosset, P, Gebhard, F, Hernigou, P, Baldini, N, Rouard, H, Sensebé, L, Gonzalo-Daganzo, RM, Giordano, R, Padilla-Eguiluz, N, et al
Biomaterials. 2019;:100-108
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).
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Maxillary Sinus Lift with Beta-Tricalcium Phosphate (β-TCP) in Edentulous Patients: A Nanotomographic and Raman Study.
Pascaretti-Grizon, F, Guillaume, B, Terranova, L, Arbez, B, Libouban, H, Chappard, D
Calcified tissue international. 2017;(3):280-290
Abstract
Sinus lift elevation restores bone mass at the maxilla in edentulate patients before the placement of dental implants. It consists of opening the lateral side of the sinus and grafting beta-tricalcium phosphate granules (β-TCP) under the olfactory membrane. Bone biopsies were obtained in five patients after 60 weeks. They were embedded undecalcified in poly(methyl methacrylate) (pMMA); blocks were analyzed by nanocomputed tomography (nanoCT); specific areas were studied by Raman microspectroscopy. Remnants of β-TCP were osseointegrated and covered with mineralized bone; osteoid tissue was also filling the inner porosity. Macrophages having engulfed numerous β-TCP grains were observed in marrow spaces. β-TCP was identified by nanoCT as osseointegrated particles and as granules in the cytoplasm of macrophages. Raman microspectroscopy permitted to compare the spectra of β-TCP and bone in different areas. The ratio of the ~820 cm-1 band of pMMA (-CH2 groups) on the ν1 phosphate band at 960 cm-1 reflected tissue hydration because water was substituted by MMA during histological processing. In bone, the ratio of the ~960 cm-1 phosphate to the amide 1 band and the ratio ν2 phosphate band by the 1240-1250 amide III band reflect the mineralization degree. Specific bands of β-TCP were found in osseointegrated β-TCP granules and in the grains phagocytized by the macrophages. The hydration degree was maximal for β-TCP phagocytized by macrophages. Raman microspectroscopy associated with nanoCT is a powerful tool in the analysis of the biomaterial degradation and osseointegration.
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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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A phase IIa randomized controlled pilot study evaluating the safety and clinical outcomes following the use of rhGDF-5/β-TCP in regenerative periodontal therapy.
Windisch, P, Stavropoulos, A, Molnár, B, Szendröi-Kiss, D, Szilágyi, E, Rosta, P, Horváth, A, Capsius, B, Wikesjö, UM, Sculean, A
Clinical oral investigations. 2012;(4):1181-9
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Abstract
To present the safety profile, the early healing phase and the clinical outcomes at 24 weeks following treatment of human intrabony defects with open flap debridement (OFD) alone or with OFD and rhGDF-5 adsorbed onto a particulate β-tricalcium phosphate (β-TCP) carrier. Twenty chronic periodontitis patients, each with at least one tooth exhibiting a probing depth ≥6 mm and an associated intrabony defect ≥4 mm entered the study. Ten subjects (one defect/patient) were randomized to receive OFD alone (control) and ten subjects OFD combined with rhGDF-5/β-TCP. Blood samples were collected at screening, and at weeks 2 and 24 to evaluate routine hematology and clinical chemistry, rhGDF-5 plasma levels, and antirhGDF-5 antibody formation. Plaque and gingival indices, bleeding on probing, probing depth, clinical attachment level, and radiographs were recorded pre- and 24 weeks postsurgery. Comparable safety profiles were found in the two treatment groups. Neither antirhGDF-5 antibody formation nor relevant rhGDF-5 plasma levels were detected in any patient. At 6 months, treatment with OFD + rhGDF-5/β-TCP resulted in higher but statistically not significant PD reduction (3.7 ± 1.2 vs. 3.1 ± 1.8 mm; p = 0.26) and CAL gain (3.2 ± 1.7 vs. 1.7 ± 2.2 mm; p = 0.14) compared to OFD alone. In the tested concentration, the use of rhGDF-5/β-TCP appeared to be safe and the material possesses a sound biological rationale. Thus, further adequately powered, randomized controlled clinical trials are warranted to confirm the clinical relevance of this new approach in regenerative periodontal therapy. rhGDF-5/β-TCP may represent a promising new techology in regenerative periodontal therapy.
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Biocompatibility of dialysis fluid for online HDF.
Tomo, T, Shinoda, T
Contributions to nephrology. 2011;:89-98
Abstract
We investigated the effects of online hemodiafiltration (HDF) using acetate-free bicarbonate dialysis (AFD) fluid on bioincompatibility as represented by inflammatory markers in patients undergoing maintenance hemodialysis therapy and compared it with conventional acetate-containing bicarbonate dialysis (ACD) fluid. A total of 24 maintenance hemodialysis patients were registered for cross-over design during the 6-month study period (13 males and 11 females, aged 58.2 ± 14.5 years, mean duration of dialysis 10.0 ± 8.0 years, chronic glomerular nephritis in 20 patients, diabetic nephropathy in 2 patients, polycystic kidney in 1 patient, and nephrosclerosis in 1 patient). These patients were subjected to ACD for the first 3 months followed by AFD fluid for the latter 3 months. Blood variables of C-reactive protein and interleukin-6 were determined after each of the first and latter 3-month periods. The filters (membrane surface area, raw material), the conditions of HDF (blood flow rate, dialysate flow rate, dialysis time, dry weight, pre-dilution mode and convective volume) and drug regimen including erythrocyte-simulating agent (drug type, dosage) were unchanged throughout the cross-over study. There appeared to be significantly higher levels of predialysis blood pH and bicarbonate in the AFD phase than in the ACD phase. Blood C-reactive protein and interleukin-6 levels were significantly decreased in AFD group as compared with those seen in ACD group. From these results, it can be suggested that online HDF using AFD fluid contributes to alleviating microinflammation, a prognostic factor for bioincompatible events in hemodialysis patients.
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[Synthetic biocompatible degradable material for juvenile bone cyst treatment].
Gál, P, Ondrus, S, Skvaril, J, Straka, M, Jochymek, J, Plánka, L
Acta chirurgiae orthopaedicae et traumatologiae Cechoslovaca. 2009;(6):495-500
Abstract
PURPOSE OF THE STUDY Owing to advances in operative techniques and biotechnology, bone replacement biocompatible materials have recently come into focus for orthopaedic and trauma surgeons. Bone lytic lesions, such as tumorous bone defects, diseases simulating cancer, chronic inflammatory lesions or skeletal injuries, often require stabilisation of the skeleton and treatment of the bone affected. Juvenile bone cysts are benign lytic lesions posing a threat to bone compactness in childhood. They are benign, fluid containing bone cavities, lined with a membrane consisting of thin vascularised connective tissue with scattered osteoclast-like cells. These cysts are usually diagnosed between; five and twenty years of age outside this age range their occurrence is rare. MATERIAL The group comprised the patients treated for juvenile bone cysts at the Department of Paediatric Surgery, Orthopaedics and Traumatology between 2001 and 2007. In the 2001-2003 period, 24 patients were treated with Depo-Medrol. Between January 2005 and December 2007, 31 patients with the same diagnosis were treated by minimally invasive application of chronOs Inject. METHODS The aim of the study was to compare these two methods of juvenile cyst therapy, i.e., the most widely used method of repetitive Depo-Medrol applications against the novel method based on filling the cyst with chronOs Inject, a synthetic biocompatible resorbable material. An alternative hypothesis assumed that the new method would result in fewer necessary operations in patients with juvenile cyst and better treatment outcomes, as evaluated by Neer's criteria for bone cyst therapy. RESULTS A total of 20 surgical interventions were performed in 18 patients treated by chronOs Inject and 100% cyst healing without necessity of additional surgery was achieved. Of the 24 patients treated with Depo-Medrol, 12 patients (50%) showed cyst healing wit no further surgery required. A total of 69 applications were needed. DISCUSSION An impetus to introduce the novel method of juvenile cyst treatment stemmed from the unsatisfactory results of the previous treatment with repetitive Depo-Medrol applications requiring additional open surgery and spongioplasty to fill the cyst. For filling cysts and other benign bone defects jeopardizing bone stability, such as deep metaphyseal fibrous defect, non-ossifying fibroma, enchondroma or fibrous dysplastic lesion, synthetic tricalcium phosphate in the form of chronOs granules was used, but without the possibility of minimally invasive percutaneous application. As soon s the resorbable chronOs Inject became available, the minimally invasive method of filling cysts with this material was adopted. CONCLUSIONS The results showed that, in the patients treated by the chronOs Inject method, the outcomes achieved were significantly better than those in the patients treated with Depo-Medrol. The difference was in the number of operations needed, which were significantly fewer in the chronOs Inject method, as well as in the overall treatment outcome, with significantly more frequent excellent results in the chronOs Inject method.
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Beta tricalcium phosphate: observation of use in 100 posterolateral lumbar instrumented fusions.
Epstein, NE
The spine journal : official journal of the North American Spine Society. 2009;(8):630-8
Abstract
BACKGROUND Beta tricalcium phosphate (B-TCP) is increasingly used to supplement lamina autograft to perform posterolateral lumbar-instrumented arthrodesis. PURPOSE To determine the radiographic arthrodesis and pseudarthrosis rates after multisegment lumbar laminectomies and one- or two-segment posterolateral instrumented fusion using lamina autograft and an artificial bone graft expander B-TCP (Vitoss; Orthovita, Malvern, PA, USA). STUDY DESIGN/SETTING To document radiographic arthrodesis/pseudarthrosis rates using lamina autograft and B-TCP. PATIENT SAMPLE One hundred patients with lumbar spinal stenosis underwent multisegment laminectomies (average 3.6 segments) and one- (78 patients) or two- (22 patients) segment posterolateral instrumented arthrodesis. OUTCOME MEASURES Two-year postoperative outcomes were assessed using Short-Form 36 questionnaires. METHODS The arthrodesis mass consisted of lamina autograft and B-TCP. Two independent neuroradiologists, using both dynamic X-rays and 2D-CT studies performed 3, 4.5, 6, and up to 12 months postoperatively, documented radiographic arthrodesis progression. RESULTS One-segment arthrodesis was performed in 79 patients; 74 (93.7%) were radiographically fused "early" (6.5 postoperative months), 2 (2.5%) fused "late" (6.5-12 months), and 3 (3.8%) exhibited pseudarthrosis. Two-segment arthrodesis was performed in 21 patients; 14 (66.7%) radiographically fused "early," 5 (23.8%) fused "late," and 2 (9.5%) exhibited pseudarthrosis. Although chi-square analyses revealed a significant increase in the number of "late" radiographic fusions occurring for patients undergoing two-level arthrodesis, no significant difference in radiographic pseudarthrosis rates was noted between the two patient populations. In both groups, Short-Form 36 questionnaires revealed nearly comparable maximal improvement on seven of eight Health Scales by the second postoperative year. CONCLUSIONS At 6.5 months after multisegment lumbar laminectomies with posterolateral instrumented lumbar arthrodesis using lamina autograft/B-TCP, more one-segment (93.7%) versus two-segment (66.7%) radiographic arthrodesis occurred. By 1 year after operation, there was no significant difference in fusion rates between one- and two-segment radiographic arthrodeses.
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Efficacy and safety of Hylan G-F 20 in shoulder osteoarthritis with an intact rotator cuff. Open-label prospective multicenter study.
Noël, E, Hardy, P, Hagena, FW, Laprelle, E, Goebel, F, Faure, C, Favard, L, Gaudin, P, Christ, R, Baudot, C, et al
Joint bone spine. 2009;(6):670-3
Abstract
OBJECTIVE To evaluate the feasibility, safety, and symptomatic efficacy of intra-articular Hylan G-F 20 in patients with shoulder osteoarthritis and an intact rotator cuff. METHODS Open-label, prospective, multicenter study in patients with pain scores on a visual analog scale (VAS) between 40/100 and 90/100. An intra-articular injection of 2 ml of Hylan G-F 20 was given under fluoroscopic guidance. A second injection was given after 1, 2, or 3 months in the event of inadequate pain relief. The primary evaluation criterion was the VAS pain score 3 months after the first injection. Follow-up was 6 months. RESULTS Of 39 included patients, 33 received a first injection and, among these, 16 received a second injection; 29 patients completed the study. No serious or severe treatment-related adverse events were recorded. There were 10 mild or moderate adverse events in eight patients. The mean VAS pain score decreased from 61.2 mm at baseline to 37.1 mm after 3 months (P<0.001), and the decrease was larger in the subgroup that required a single injection. CONCLUSION This prospective study shows that treatment with one or two intra-articular injections of Hylan GF 20 in patients who have shoulder osteoarthritis and an intact cuff is feasible, safe, and probably effective. Viscosupplementation using Hylan G-F 20 may constitute a helpful treatment option in patients who have shoulder osteoarthritis with an intact rotator cuff.