Biphasic hydroxyapatite and calcium sulfate cement found noninferior to autologous bone graft
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A bioresorbable hydroxyapatite and calcium sulfate cement as a filler was noninferior to autologous bone graft regarding subjective outcomes for patients with tibial plateau fractures, according to a published study.
“In this study, we showed that the use of bioresorbable hydroxyapatite and calcium sulfate biomaterial for augmentation of bone defects in OTA/AO 41-B2 and OTA/AO 41-B3 fractures is noninferior to autologous iliac crest bone in terms of patient-reported functional outcomes and pain levels at 26 weeks,” Alexander Hofmann, MD, PhD, of the department of traumatology and orthopedics at the Academic Teaching Hospital of the Universities Mainz and Heidelberg at Westpfalz-Clinics in Kaiserslautern, Germany, and colleagues wrote.
In total, 133 adult patients with an isolated, acute, traumatic, closed, depression-type, OTA/AO 41-B2 or OTA/AO 41-B3 proximal tibial fracture that required metaphyseal bone defect reconstruction were enrolled in the study. Patients were randomized to two groups. In the first group, autologous bone grafts were gathered from the ipsilateral anterior part of the iliac crest. In the second group, a bioresorbable hydroxyapatite and calcium sulfate cement (Cerament bone void filler [CBVF] by BoneSupport), was used.
Primary outcome measures were the short-form (SF)-12 version 2 physical component summary (PCS) score at week 26 and the VAS for pain at week 26. Secondary outcome measures were the SF-12 version 2 mental component summary (MCS) scores and SF-12 physical component summary (PCS) scores at 1, 6 and 12 weeks and bone-healing evaluations.
A valid SF-12 assessment at baseline and after 26 weeks were found in 108 patients (52 patients in the autologous iliac bone-graft group and 56 patients in the CBVF group) and were defined as the modified intent-to-treat population. A total of 95 patients completed the study without major protocol deviations (47 patients in the autologous iliac bone-graft group and 48 patients in the CBVF group) and were defined as the per-protocol population.
Results of the SF-12 PCS score showed similar outcomes in both groups, with 42 points in the autologous iliac bone-graft group and 43 points in the CBVF group on average. At week 26, the SF-12 MCS scores were similar in both groups, with a mean value of 60 points. VAS scores at week 1 were 2 points in both groups, increasing until week 6 and showing no significant difference between groups at 6 months.
“This prospective, multicenter, randomized trial showed noninferiority of CBVF compared with autologous iliac bone graft in tibial plateau fractures with noninferior patient-reported outcomes,” the researchers wrote. – by Erin T. Welsh
Disclosures: Hofmann reports receiving personal fees from BoneSupport ABT. Please see the study for other authors’ relevant financial disclosures.
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