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

BACKGROUND 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. METHODS 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. RESULTS 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. CONCLUSIONS 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. TRIAL REGISTRATION ClinicalTrials NCT02567084 Release Date 10/01/2015.