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Multi-centre, randomized clinical trial on the efficacy and safety of recombinant human platelet-derived growth factor with β-tricalcium phosphate in human intra-osseous periodontal defects.
Jayakumar, A, Rajababu, P, Rohini, S, Butchibabu, K, Naveen, A, Reddy, PK, Vidyasagar, S, Satyanarayana, D, Pavan Kumar, S
Journal of clinical periodontology. 2011;(2):163-72
Abstract
AIM: the objective of the study was to evaluate the safety and efficacy of a formulation containing recombinant human platelet-derived growth factor (rhPDGF-BB) and β-tricalcium phosphate (β-TCP) in patients with periodontal defects and to compare it with those of β-TCP alone. MATERIALS AND METHODS in this double-blind, prospective, parallel, active-controlled, randomized, multi-centre clinical trial, 54 patients with periodontal osseous defects were randomly assigned to rhPDGF-BB+β-TCP or β-TCP. Following periodontal surgery, respective implantation was performed. The primary and secondary end points of treatment were evaluated at the third and the sixth month. RESULTS among the outcome measures, the extent of linear bone growth (p<0.01) and per cent bone fill (p<0.004) at the sixth month over baseline were significantly higher in the rhPDGF-BB+β-TCP group when compared with the β-TCP group. Similarly, it also resulted in significantly higher area under the curve clinical attachment level gain at 0-6 months (p<0.01), CAL gain and greater reduction in probing depth at the third and the sixth month than that with β-TCP treatment alone. The incidence of adverse events was similar in both the groups and no serious adverse events were reported in any of the patients. CONCLUSIONS rhPDGF-BB+β-TCP is safe and effective in the treatment of periodontal defects. It increases bone formation and soft tissue healing (clinicaltrials.gov, number NCT00496847; CTRI No.: CTRI/2008/091/000152).
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Prospective clinical pilot trial in a single cohort group of rhPDGF in foot arthrodeses.
Daniels, T, DiGiovanni, C, Lau, JT, Wing, K, Younger, A
Foot & ankle international. 2010;(6):473-9
Abstract
BACKGROUND Augment Bone Graft, a fully synthetic bone graft material composed of recombinant human PDGF and a calcium phosphate matrix (rhPDGF/TCP), has been considered as a possible alternative to autogenous bone graft. Before proceeding with randomized control studies comparing rhPDGF/TCP to autograft bone, a human trial to assess efficacy and safety was required. MATERIALS AND METHODS The current study was a prospective, open-label, multi-center trial designed to evaluate rhPDGF in a calcium phosphate matrix (Augment Bone Graft). Sixty patients requiring hindfoot or midfoot fusion were prospectively followed for 36 weeks. All patients received 0.9 to 2.7 mg of rhPDGF at the fusion sites and returned for clinical and radiographic review at Day 7 to 14 and Weeks 6, 9, 12, 16, 24, and 36. Computerized tomography (CT) scans of the fusion site were obtained at the 6- and 12-week postoperative appointment, with an additional CT scan at 16 weeks if required. RESULTS No patients suffered a serious adverse event caused by rhPDGF. CT scan evaluation at 12- to 16-week time periods revealed moderate or complete osseous bridging of 75% (44/59) at 36 weeks. CONCLUSION These results indicate that rhPDGF is a safe product and provides clinical/radiographic outcomes that justify the pursuit of randomized controlled studies comparing rhPDGF/TCP to autograft.
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Comparison of autogenous bone graft and endothermic calcium phosphate cement for defect augmentation in tibial plateau fractures. A multicenter, prospective, randomized study.
Russell, TA, Leighton, RK, ,
The Journal of bone and joint surgery. American volume. 2008;(10):2057-61
Abstract
BACKGROUND Bone graft augmentation is often selected to treat defects associated with unstable tibial plateau fractures. This prospective, randomized, multicenter study was undertaken to determine the efficacy of bioresorbable calcium phosphate cement compared with standard autogenous iliac bone graft in the treatment of these osseous defects. METHODS One hundred and twenty acute, closed, unstable tibial plateau fractures (Schatzker types I through VI) in 119 adult patients were prospectively enrolled in twelve study sites in North America between 1999 and 2002. Randomization for the type of grafting of the subarticular defect was done at the time of surgery, with use of a 2:1 ratio, to treatment with calcium phosphate cement (eighty-two fractures) or autogenous iliac bone graft (thirty-eight fractures). After open reduction, standard plate-and-screw or screw-only fixation was used and then either the cement or the bone graft was placed in the defect cavity for subarticular support. Follow-up included standard radiographs, evaluated by multiple reviewers to avoid bias, and knee range-of-motion assessment at six months to one year or later. RESULTS The age, weight, height, and sex of the patients and the fracture patterns were comparable in the two groups, as were union rates and time to union. There was a significantly (p = 0.009) higher rate of articular subsidence during the three to twelve-month follow-up period in the bone graft group. CONCLUSIONS The bioresorbable calcium phosphate cement used in this study appears to be a better choice, at least in terms of the prevention of subsidence, than autogenous iliac bone graft for the treatment of subarticular defects associated with unstable tibial plateau fractures. LEVEL OF EVIDENCE Therapeutic Level I. See Instructions to Authors for a complete description of levels of evidence.
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Maxillary sinus grafting with Bio-Oss or Straumann Bone Ceramic: histomorphometric results from a randomized controlled multicenter clinical trial.
Cordaro, L, Bosshardt, DD, Palattella, P, Rao, W, Serino, G, Chiapasco, M
Clinical oral implants research. 2008;(8):796-803
Abstract
INTRODUCTION This investigation was designed to compare the histomorphometric results from sinus floor augmentation with anorganic bovine bone (ABB) and a new biphasic calcium phosphate, Straumann Bone Ceramic (BCP). MATERIALS AND METHODS Forty-eight maxillary sinuses were treated in 37 patients. Residual bone width was > or =6 mm and height was > or =3 mm and <8 mm. Lateral sinus augmentation was used, with grafting using either ABB (control group; 23 sinuses) or BCP (test group; 25 sinuses); sites were randomly assigned to the control or test groups. After 180-240 days of healing, implant sites were created and biopsies taken for histological and histomorphometric analyses. The parameters assessed were (1) area fraction of new bone, soft tissue, and graft substitute material in the grafted region; (2) area fraction of bone and soft tissue components in the residual alveolar ridge compartment; and (3) the percentage of surface contact between the graft substitute material and new bone. RESULTS Measurable biopsies were available from 56% of the test and 81.8% of the control sites. Histology showed close contact between new bone and graft particles for both groups, with no significant differences in the amount of mineralized bone (21.6+/-10.0% for BCP vs. 19.8+/-7.9% for ABB; P=0.53) in the biopsy treatment compartment of test and control site. The bone-to-graft contact was found to be significantly greater for ABB (48.2+/-12.9% vs. 34.0+/-14.0% for BCP). Significantly less remaining percentage of graft substitute material was found in the BCP group (26.6+/-5.2% vs. 37.7+/-8.5% for ABB; P=0.001), with more soft tissue components (46.4+/-7.7% vs. 40.4+/-7.3% for ABB; P=0.07). However, the amount of soft tissue components for both groups was found not to be greater than in the residual alveolar ridge. DISCUSSION Both ABB and BCP produced similar amounts of newly formed bone, with similar histologic appearance, indicating that both materials are suitable for sinus augmentation for the placement of dental implants. The potential clinical relevance of more soft tissue components and different resorption characteristics of BCP requires further investigation.
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A prospective multicenter randomized clinical trial of autogenous bone versus beta-tricalcium phosphate graft alone for bilateral sinus elevation: histologic and histomorphometric evaluation.
Szabó, G, Huys, L, Coulthard, P, Maiorana, C, Garagiola, U, Barabás, J, Németh, Z, Hrabák, K, Suba, Z
The International journal of oral & maxillofacial implants. 2005;(3):371-81
Abstract
PURPOSE Two different graft materials, beta-tricalcium phosphate (Cerasorb) and autogenous bone, were used in the same patient. The objective was to determine whether donor site morbidity could be avoided by using pure-phase beta-tricalcium phosphate (Cerasorb). MATERIALS AND METHODS Bilateral sinus grafting was performed on 20 selected patients; Cerasorb was used on the experimental side, and autogenous bone was used on the control side. In each patient, one side was randomly designated the experimental side. In 10 of the 20 patients, the maxilla reconstruction included sinus grafting and onlay bone grafting. Implants were placed 6 months after the procedure. In addition to routine panoramic radiographs, in 10 of the 20 patients, 2- and 3-dimensional computerized tomographic examinations were performed pre- and postoperatively and after implantation. Eighty bone biopsy specimens were taken at the time of implant placement. RESULTS Histologically and histomorphometrically, there was no significant difference between the experimental and control grafts in terms of the quantity and rate of ossification. For each histologic sample, the total surface area, the surface area that consisted of bone, and the surface area that consisted of graft material were measured in mm2, and bone and graft material were analyzed as percentages of the total. The mean percentage bone areas were 36.47% +/- 6.9% and 38.34% +/- 7.4%, respectively; the difference was not significant (P = .25). DISCUSSION AND CONCLUSION Comparisons with other studies reveal that beta-tricalcium phosphate (Cerasorb) is a satisfactory graft material, even without autogenous bone.
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Use of recombinant human bone morphogenetic protein-2 to achieve posterolateral lumbar spine fusion in humans: a prospective, randomized clinical pilot trial: 2002 Volvo Award in clinical studies.
Boden, SD, Kang, J, Sandhu, H, Heller, JG
Spine. 2002;(23):2662-73
Abstract
STUDY DESIGN A prospective randomized clinical study was conducted. OBJECTIVE To determine whether the dose and carrier that were successful in rhesus monkeys could induce consistent radiographic spine fusion in humans. SUMMARY OF BACKGROUND DATA Preclinical studies have demonstrated that recombinant human bone morphogenetic protein-2 (rhBMP-2), an osteoinductive bone morphogenetic protein, is successful at generating spine fusion in rabbits and rhesus monkeys. METHODS For this study, 25 patients undergoing lumbar arthrodesis were randomized (1:2:2 ratio) based on the arthrodesis technique: autograft/Texas Scottish Rite Hospital (TSRH) pedicle screw instrumentation (n = 5), rhBMP-2/TSRH (n = 11), and rhBMP-2 only without internal fixation (n = 9). On each side, 20 mg of rhBMP-2 were delivered on a carrier consisting of 60% hydroxyapatite and 40% tricalcium phosphate granules (10 cm /side). The patients had single-level disc degeneration, Grade 1 or less spondylolisthesis, mechanical low back pain with or without leg pain, and at least 6 months failure of nonoperative treatment. RESULTS All 25 patients were available for follow-up evaluation (mean, 17 months; range 12-27 months). The radiographic fusion rate was 40% (2/5) in the autograft/TSRH group and 100% (20/20) with rhBMP-2 group with or without TSRH internal fixation ( = 0.004). A statistically significant improvement in Oswestry score was seen at 6 weeks in the rhBMP-2 only group (-17.6; = 0.009), and at 3 months in the rhBMP-2/TSRH group (-17.0; = 0.003), but not until 6 months in the autograft/TSRH group (-17.3; = 0.041). At the final follow-up assessment, Oswestry improvement was greatest in the rhBMP-2 only group (-28.7, < 0.001). The SF-36 Pain Index and PCS subscales showed similar changes. DISCUSSION This pilot study is the first with at least 1 year of follow-up evaluation to demonstrate successful posterolateral spine fusion using a BMP-based bone graft substitute, with radiographs and CT scans as the determinant. Consistently, rhBMP-2 was able to induce bone in the posterolateral lumbar spine when delivered at a dose of 20 mg per side with or without the use of internal fixation. Patients with spondylolisthesis classified higher than Meyerding Grade 1 or with more than 5 mm of translational motion may still require internal fixation. Some patients did smoke during the postoperative period, and all in the rhBMP-2 groups still obtained solid fusions. CONCLUSIONS Consistently, rhBMP-2 with the biphasic calcium phosphate granules induced radiographic posterolateral lumbar spine fusion with or without internal fixation in patients whose spondylolisthesis did not exceed Grade 1. Statistically greater and quicker improvement in patient-derived clinical outcome was measured in the rhBMP-2 groups.
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The use of a surgical grade calcium sulfate as a bone graft substitute: results of a multicenter trial.
Kelly, CM, Wilkins, RM, Gitelis, S, Hartjen, C, Watson, JT, Kim, PT
Clinical orthopaedics and related research. 2001;(382):42-50
Abstract
In a prospective, nonrandomized, multicenter study, 109 patients with bone defects were treated with a surgical grade calcium sulfate preparation as a bone graft substitute. The calcium sulfate pellets were used in place of morselized cancellous bone graft for the treatment of patients with bone defects who usually would require grafting secondary to trauma, periprosthetic bone loss, tumor, or fusion. The calcium sulfate was used alone or mixed with other materials such as bone marrow aspirate, demineralized bone matrix, or autograft. The defects that were treated were contained and were not necessary for the stability of the bony structure. Radiographic and clinical data were collected at predetermined intervals for 12 months. At 6 months postoperatively, radiographic results for all patients showed that 99% of the calcium sulfate had been resorbed and 88% of the defect was filled with trabeculated bone. There were 13 complications; however, only four (3.6%) were attributable to the product. The results of a subgroup of 46 patients with benign bone lesions treated in the same manner are identical to the results of the overall study population. Surgical grade calcium sulfate pellets are considered a convenient, safe, and readily available bone graft substitute that yield consistent successful results.