No effect of Osteoset ® , a bone graft substitute, on bone healing in humans: A prospective randomized double-blind study

Petruskevicius, Juozas; Nielsen, Strange; Kaalund, Søren; Knudsen, P.; Overgaard, Søren

doi:10.1080/000164702321022875

Cited by 51 publications

(25 citation statements)

References 6 publications

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“…Petruskevicius et al, however, do not recommend Osteoset for implantation in humans, as 6 weeks is too short a time for complete resorption. In order to decrease the rate of resorption, addition of a substance, e.g., calcium phosphate, was recommended (28).…”

Section: Discussionmentioning

confidence: 99%

Antimicrobial Formulations of Absorbable Bone Substitute Materials as Drug Carriers Based on Calcium Sulfate

Pförringer

Obermeier

Kiokekli

et al. 2016

Antimicrob Agents Chemother

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c Substitution of bones is a well-established, necessary procedure to treat bone defects in trauma and orthopedic surgeries. For prevention or treatment of perioperative infection, the implantation of resorbable bone substitute materials carrying antibiotics is a necessary treatment. In this study, we investigated the newly formulated calcium-based resorbable bone substitute materials containing either gentamicin (CaSO 4 -G [Herafill-G]), vancomycin (CaSO 4 -V), or tobramycin (Osteoset). We characterized the released antibiotic concentration per unit. Bone substitute materials were implanted in bones of rabbits via a standardized surgical procedure. Clinical parameters and levels of the antibiotic-releasing materials in serum were determined. Local concentrations of antibiotics were measured using antimicrobial tests of bone tissue. Aminoglycoside release kinetics in vitro per square millimeter of bead surface showed the most prolonged release for gentamicin, followed by vancomycin and, with the fastest release, tobramycin. In vivo level in serum detected over 28 days was highest for gentamicin at 0.42 g/ml, followed by vancomycin at 0.11 g/ml and tobramycin at 0.04 g/ml. The clinical parameters indicated high biocompatibility for materials used. None of the rabbits subjected to the procedure showed any adverse reaction. The highest availability of antibiotics at 14.8 g/g on day 1 in the cortical tibia ex vivo was demonstrated for gentamicin, decreasing within 14 days. In the medulla, vancomycin showed a high level at 444 g/g on day 1, decreasing continuously over 14 days, whereas gentamicin decreased faster within the initial 3 days. The compared antibiotic formulations varied significantly in release kinetics in serum as well as locally in medulla and cortex.

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Section: Discussionmentioning

confidence: 99%

Antimicrobial Formulations of Absorbable Bone Substitute Materials as Drug Carriers Based on Calcium Sulfate

Pförringer

Obermeier

Kiokekli

et al. 2016

Antimicrob Agents Chemother

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“…The authors studied the amount of new bone formation with serial computed tomography (CT) scans at 0, 6, 12, and 24 weeks. 43 Significantly increased new bone was found in both groups from zero to six weeks and significantly increased bone was observed in the control group alone from six to 12 weeks compared with Osteoset (p=0.01).…”

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confidence: 85%

A Comparison of Mineral Bone Graft Substitutes for Bone Defects

Allison¹,

Lindberg²,

Samimi³

et al. 2011

Oncology &Amp; Hematology Review (US)

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Cavitary bone defects are created in the curettage or debridement of benign bone tumors, infections, or low-grade malignancies. In order for new bone to fill these defects, the material that resides within must be osteoconductive, or an appropriate scaffolding that prevents non-osseous (fibrous) tissue infiltration, supports the attachment of new osteoblasts and osteoprogenitor cells, and sustains an interconnected structure through which new cells can migrate and new vessels can form. 1The subsequent substance that develops through this osteoconductive step must also be osteoinductive (facilitate the travel of factors and materials for cellular differentiation) and osteogenic (cause the cellular production of new bone) for new bone to form. 1 Current US consensus dictates that in order for this cascade to develop in a bone defect, a graft must be used. In fact, over 500,000 bone graft procedures are performed annually in the US.2 In order to meet the first and crucial step of osteoconductivity, the graft must fill the void and provide a scaffolding on which stem cells can attach;in order to facilitate the next two critical steps, the graft must be non-inflammatory and non-toxic and resorb at a rate roughly equal to that of bone formation. Prospective randomized clinical trials in the treatment of bone tumors are necessary to properly delineate the real indications for bone grafting and to demonstrate the graft's efficacy in this regard. KeywordsMineral ceramic bone graft substitute, bone defect, bone void Disclosure:The authors have no conflicts of interest to declare.

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“…It does not always reflect the conditions under which the biomaterial will be used in clinical patients. Therefore, some discrepancies between in vivo results from experimental animals and further clinical trials conducted on humans could occur (10). For such reasons in the described experiment the biomaterial was introduced directly into the fracture site and the healing process was further complicated by the creation of a bone defect.…”

Section: Discussionmentioning

confidence: 99%

Use of Calcium Sulfate as a Biomaterial in the Treatment of Bone Fractures in Rabbits – Preliminary Studies

Szponder

Mytnik

Jaegermann³

2013

Bulletin of the Veterinary Institute in Pulawy

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The paper presents preliminary results of the implantation of calcium sulfate type Hartform HF1 developed at the Institute of Glass and Ceramics in Warsaw. The study was conducted on 10 New Zealand White rabbits, in which after tibial osteotomy the biomaterial was implanted directly into the fracture site. The animals were divided into two groups based on the method of fracture stabilisation: intramedullary pinning using Kirschner wires in one group and acrylic external fixator in the other. After 12 weeks, bone union was observed in all animals as estimated by clinical and radiological findings. Histological tests revealed resorption of the biomaterial into the bone fracture area. It was concluded that type Hartform 1 calcium sulfate can be used as a biomaterial in veterinary orthopedics. Due to the lack of observable side effects during implantation and resorption, the material can be considered as a valuable ingredient in composite biomaterials containing calcium sulfate.

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No effect of Osteoset ® , a bone graft substitute, on bone healing in humans: A prospective randomized double-blind study

Cited by 51 publications

References 6 publications

Antimicrobial Formulations of Absorbable Bone Substitute Materials as Drug Carriers Based on Calcium Sulfate

Antimicrobial Formulations of Absorbable Bone Substitute Materials as Drug Carriers Based on Calcium Sulfate

A Comparison of Mineral Bone Graft Substitutes for Bone Defects

Use of Calcium Sulfate as a Biomaterial in the Treatment of Bone Fractures in Rabbits – Preliminary Studies

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