CERAMENT treatment of fracture defects (CERTiFy): protocol for a prospective, multicenter, randomized study investigating the use of CERAMENT™ BONE VOID FILLER in tibial plateau fractures.

BACKGROUND: Bone graft substitutes are widely used for reconstruction of posttraumatic bone defects. However, their clinical significance in comparison to autologous bone grafting, the gold-standard in reconstruction of larger bone defects, still remains under debate. This prospective, randomized, controlled clinical study investigates the differences in pain, quality of life, and cost of care in the treatment of tibia plateau fractures-associated bone defects using either autologous bone grafting or bioresorbable hydroxyapatite/calcium sulphate cement (CERAMENT™|BONE VOID FILLER (CBVF)). METHODS/DESIGN: CERTiFy (CERament™ Treatment of Fracture defects) is a prospective, multicenter, controlled, randomized trial. We plan to enroll 136 patients with fresh traumatic depression fractures of the proximal tibia (types AO 41-B2 and AO 41-B3) in 13 participating centers in Germany. Patients will be randomized to receive either autologous iliac crest bone graft or CBVF after reduction and osteosynthesis of the fracture to reconstruct the subchondral bone defect and prevent the subsidence of the articular surface. The primary outcome is the SF-12 Physical Component Summary at week 26. The co-primary endpoint is the pain level 26 weeks after surgery measured by a visual analog scale. The SF-12 Mental Component Summary after 26 weeks and costs of care will serve as key secondary endpoints. The study is designed to show non-inferiority of the CBVF treatment to the autologous iliac crest bone graft with respect to the physical component of quality of life. The pain level at 26 weeks after surgery is expected to be lower in the CERAMENT bone void filler treatment group. DISCUSSION: CERTiFy is the first randomized multicenter clinical trial designed to compare quality of life, pain, and cost of care in the use of the CBVF and the autologous iliac crest bone graft in the treatment of tibia plateau fractures. The results are expected to influence future treatment recommendations. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov: NCT01828905.

Autologous bone flap versus hydroxyapatite prosthesis in first intention in secondary cranioplasty after decompressive craniectomy: a French medico-economical study.

BACKGROUND AND PURPOSE: Decompressive craniectomy is the most common justification for cranioplasty. A medico-economial study based on the effective cost of the hydroxyapatite prosthesis, the percentage of autologous bone graft's loss due to bacterial contamination and the healthcare reimbursment, will allow us to define the best strategy in term of Healthcare economy management for the cranioplasties. A comparison was made between the two groups of patients, autologous bone flap versus custom-made prosthesis in first intention, based on the clinical experience of our department of neurosurgery. RESULTS: No differences was shown between the two groups of patients, in terms of lenght of in-hospital stay and population's characteristics or medical codification. The mean cost of a cranioplasty using the autologous bone graft in first intention was €4045, while the use of hydroxyapatite prosthesis led to a cost of €8000 per cranioplasty. CONCLUSION: In term of Healthcare expenses, autologous bone flap should be used in first intention for cranioplasties, unless the flap is contaminated or in specific indications, when the 3D custom-made hydroxyapatite prosthesis should be privilegied.

Low-cost antibiotic loaded systems for developing countries.

Treatment of osteomyelitis with local antibiotic delivery systems has become a common practice in orthopaedic surgery. This study attempted to show that locally produced pure or bioglass reinforced plaster of Paris, hydroxyapatite and sodium alginate are promising biomaterials and mainly because of economical reasons and availability, may be an alternative in clinical practice, especially for developing countries. A total of 32 rabbits were divided into four groups (n:8). In group A, sodium alginate + cephazoline; in group B, plaster of Paris + bioglass + cephazoline; in group C, plaster of Paris + hydroxyapatite + cephazoline and in group D, plaster of Paris + cephazoline were used. The blood serum cephazoline concentrations were analyzed by high performance liquid chromatography on days 1 to 10 everyday and then at days 13, 17, 18, 24, 25 and 30. The mean values +/- standard deviations and median values of blood serum antibiotic concentrations for groups A, B, C and D were 1.45 +/- 0.40 (1.42) mcg/ml, 1.53 +/- 0.64 (1.31) mcg/ml, 1.92 +/- 0.39 mcg/ml (1.90) and 1.41 +/- 0.65 (1.25) mcg/ml, respectively. The detected antibiotic level was constantly over the minimum inhibitory concentration for Staphylococcus aureus. In conclusion, it can be stated that these materials are promising as a antibiotic delivery system even with simple production methods.

A synthetic hydroxyapatite implant: the so-called counterfeit implant.

This article evaluates three generations of synthetic hydroxyapatite implants in a rabbit model. Fourteen New Zealand white rabbits received synthetic hydroxyapatite orbital implants (first, second, and third generation). The rabbits underwent enucleation of one eye and then received a 12-mm synthetic hydroxyapatite implant wrapped in Vicryl (polygalactin 910; Ethicon, Inc.) mesh or sclera. Magnetic resonance imaging was conducted to assess host fibrovascularization of the implant 4 and 12 weeks after implantation. Animals were killed at each of these times and the implant was removed for histopathologic examination. Enhancement on magnetic resonance imaging and extent of fibrovascularization by histopathologic examination were assessed. The first-generation synthetic hydroxyapatite (FCI, Issy-Les-Moulineaux, France) was not 100% hydroxyapatite as is the Bio Eye (Integrated Orbital Implants, Inc., San Diego, CA, U.S.A.). It contained 3.2% calcium oxide. The implant was heavier and much less porous than the original Bio Eye implant. Central vascularization eventually occurred but was not extensive. The second-generation implant was more porous than the first, with rapid central vascularization to the center of the implant by 4 weeks. However, the second-generation implant was very fragile and crumbled easily. The second-generation synthetic implant was chemically identical to the original Bio Eye implant with no calcium oxide. The third-generation implant was more porous than its predecessors. When compared side by side with the Bio Eye, a difference in pore uniformity and interconnectivity seems apparent. However, an early extensive vascularization pattern to the center of the implant is seen histopathologically, similar to that with the Bio Eye. Magnetic resonance imaging also shows extensive enhancement as is the case with the Bio Eye. The third-generation synthetic implant is not fragile as was the second-generation implant, and chemically it is identical to the Bio Eye with no calcium oxide present. The third-generation implant is approximately half the price of the original Bio Eye implant.