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Complete twelve month bone remodeling with a bi-phasic injectable bone substitute in benign bone tumors: a prospective pilot study.

ABSTRACT: Benign primary bone tumors are commonly treated by surgery involving bone grafts or synthetic bone void fillers. Although synthetic bone grafts may provide early mechanical support while minimizing the risk of donor-site morbidity and disease transmission, difficult handling properties and less than optimal transformation to bone have limited their use.In a prospective series, patients with benign bone tumors were treated by minimal invasive intervention with a bi-phasic and injectable ceramic bone substitute (CERAMENT™ BONE VOID FILLER, BoneSupport, Sweden) with the hypothesis that open surgery with bone grafting might be avoided. The defects were treated by either mini-invasive surgery (solid tumors) or percutaneous injection (cysts) and followed clinically and radiologically for 12 months. CT scan was performed after 12 months to confirm bone remodeling of the bone substitute. All patients were allowed full weight bearing immediately after surgery.Fourteen patients with a median age of 13 years (range 7-75) were consecutively recruited during 11 months. Eleven lesions were bone cysts (eight unicameral and three post-traumatic) and three were solid benign tumors. The median size of the lesions was 40 mL (range 1-152). The most common location was humerus (n = 10). After 12 months the defects completely or partially filled with median 18 mL (range 5-28) of bone substitute demonstrated full resolution (Neer Classification grade I) in 11 patients, partial resolution (Neer II) in 2 patients and in 1 patient the cyst persisted (Neer III). No lesions required recurrent surgery during the observation period. No post-operative fracture or infection was recorded.Minimal invasive treatment with a bi-phasic and injectable ceramic bone substitute might offer an alternative to regular bone grafting due to convenient handling properties and rapid bone remodeling.ClinicalTrials NCT02567084 Release Date 10/01/2015.

SUBMITTER: Kaczmarczyk J

PROVIDER: S-EPMC4661983 | biostudies-literature | 2015 Nov

REPOSITORIES: biostudies-literature

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Complete twelve month bone remodeling with a bi-phasic injectable bone substitute in benign bone tumors: a prospective pilot study.

Kaczmarczyk Jacek J Sowinski Piotr P Goch Maciej M Katulska Katarzyna K

BMC musculoskeletal disorders 20151126

<h4>Background</h4>Benign primary bone tumors are commonly treated by surgery involving bone grafts or synthetic bone void fillers. Although synthetic bone grafts may provide early mechanical support while minimizing the risk of donor-site morbidity and disease transmission, difficult handling properties and less than optimal transformation to bone have limited their use.<h4>Methods</h4>In a prospective series, patients with benign bone tumors were treated by minimal invasive intervention with a ...[more]

PMID: 26612576

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Project description:BACKGROUND/AIM:The present study investigates the in vivo tissue reaction and the integration behavior of an injectable bone substitute material (IBS) composed of a water-based gel combined with nano hydroxyapatite particles and biphasic calcium phosphate granules. The results of the IBS were compared to biphasic bone substitute granules (BBSM) of the same chemical composition. MATERIALS AND METHODS:The subcutaneous implantation model in 40 female 5-week-old CD-1 mice up to 60 days after implantation was used for conduction of the in vivo experiments. Moreover, established histological, histopathological and histomorphometrical methods were applied. RESULTS:The results showed that the IBS was gradually invaded by cells and complex tissue elements. Thus, the implant bed could be distinguished in two areas, i.e. an outer and inner region. While the outer region started to interact with the peri-implant tissue by evoking multinucleated giant cells and at earlier time points by undergoing a continuous high vascularization, the inner part was free of peri-implant cells for at least 30 days, starting to undergo a similar tissue reaction at a later time point. The bone substitute granules allowed for a fast tissue influx between the interspaces of the granules starting at day 10. While the vessel density did not differ in both groups up to the end of the study, the amount of vascularization was significantly higher over the entire observation period in the BBSM group. Moreover, the amount of biomaterial-associated multinucleated giant cells (BMGCs) was significantly higher in the IBS group in the period of between 15 to 30 days after implantation, while comparable BMGC numbers were found in both groups towards the end of the study. CONCLUSION:IBS can build a barrier-like structure that is able to control the soft tissue influx into the central regions of the implantation bed, which could not be observed in other bone substitute granules of the same chemical composition. This directed integration behavior is assumed to be in accordance with the concept of Guided Bone Regeneration (GBR). Furthermore, BMGCs can significantly influence the process of angiogenesis within an implant bed of a biomaterial but not the maturity of blood vessels.

Dataset Information

Complete twelve month bone remodeling with a bi-phasic injectable bone substitute in benign bone tumors: a prospective pilot study.

Publications

Complete twelve month bone remodeling with a bi-phasic injectable bone substitute in benign bone tumors: a prospective pilot study.

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