Shinichi Sotome1, Keisuke Ae2, Atsushi Okawa2, Masafumi Ishizuki3, Hideo Morioka4, Seiichi Matsumoto5, Takashi Nakamura6, Satoshi Abe7, Yasuo Beppu8, Kenichi Shinomiya2. 1. Department of Orthopaedic Research and Development, Graduate School, Tokyo Medical and Dental University, 1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan; Department of Orthopaedic and Spinal Surgery, Graduate School, Tokyo Medical and Dental University, 1-5-45 Yushima Bunkyo-ku, Tokyo, Japan. Electronic address: sotome.orth@tmd.ac.jp. 2. Department of Orthopaedic and Spinal Surgery, Graduate School, Tokyo Medical and Dental University, 1-5-45 Yushima Bunkyo-ku, Tokyo, Japan. 3. Department of Orthopaedic Surgery, Tsuchiura Kyodo General Hospital, 11-4 Manabeshinmachi, Tsuchiura-shi, Ibaraki, Japan. 4. Department of Orthopaedic Surgery, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo, Japan. 5. Department of Orthopaedic Oncology, Cancer Institute Hospital, Japanese Foundation for Cancer Research, 3-8-31 Ariake, Kouto-ku, Tokyo, Japan. 6. Department of Orthopedic Surgery, Graduate School of Medicine, Kyoto University, 54 Shogoin Kawaramachi, Sakyo-ku, Kyoto, Japan. 7. Department of Orthopaedic Surgery, Teikyo University School of Medicine, 2-11-1 Kaga, Itabashi-ku, Tokyo, Japan. 8. Orthopedic Surgery Division, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan.
Abstract
BACKGROUND:Porous hydroxyapatite/collagen composite (HAp/Col) is a bioresorbable bone substitute composed of nano-scale HAp and porcine type 1 collagen. In this study, the efficacy and safety were assessed in comparison to commercially available porous β-tricalcium phosphate (β-TCP). METHODS:Patients with bone defects caused by benign bone tumors, fractures, or harvesting of autografts were randomly allocated for implantation of porous HAp/Col (n = 63) or porous β-TCP (n = 63). X-ray images were scored and used to evaluate the efficacy of the implantation until 24 weeks after surgery. Blood tests and observation of the surgical site were also performed to evaluate the safety of the implants. In total, 59 and 60 cases were analyzed in the porous HAp/Col and β-TCP groups, respectively. RESULTS: At 18 and 24 weeks after surgery, the highest grade of bone regeneration was more frequent in the porous HAp/Col group than in the porous β-TCP group (p = 0.0004 and 0.0254 respectively). Wilcoxon's rank sum test confirmed the superiority of porous HAp/Col from early time points onward (p = 0.0084, 4 w; p = 0.0037, 8 w; p = 0.0030, 12 w; p < 0.0001, 18 w; and p = 0.0316, 24 w). The incidence of adverse effects was higher in the porous HAp/Col group than in the β-TCP group. However, no serious adverse events were reported and no cases needed to drop out of the clinical trial. CONCLUSIONS: The superiority of porous HAp/Col for bone regeneration in comparison to an established porous β-TCP was confirmed. Although the incidence of side effects associated with the porous HAp/Col implant was higher than that in the β-TCP group, no serious adverse events occurred that resulted in rejection of the implants.
RCT Entities:
BACKGROUND: Porous hydroxyapatite/collagen composite (HAp/Col) is a bioresorbable bone substitute composed of nano-scale HAp and porcine type 1 collagen. In this study, the efficacy and safety were assessed in comparison to commercially available porous β-tricalcium phosphate (β-TCP). METHODS:Patients with bone defects caused by benign bone tumors, fractures, or harvesting of autografts were randomly allocated for implantation of porous HAp/Col (n = 63) or porous β-TCP (n = 63). X-ray images were scored and used to evaluate the efficacy of the implantation until 24 weeks after surgery. Blood tests and observation of the surgical site were also performed to evaluate the safety of the implants. In total, 59 and 60 cases were analyzed in the porous HAp/Col and β-TCP groups, respectively. RESULTS: At 18 and 24 weeks after surgery, the highest grade of bone regeneration was more frequent in the porous HAp/Col group than in the porous β-TCP group (p = 0.0004 and 0.0254 respectively). Wilcoxon's rank sum test confirmed the superiority of porous HAp/Col from early time points onward (p = 0.0084, 4 w; p = 0.0037, 8 w; p = 0.0030, 12 w; p < 0.0001, 18 w; and p = 0.0316, 24 w). The incidence of adverse effects was higher in the porous HAp/Col group than in the β-TCP group. However, no serious adverse events were reported and no cases needed to drop out of the clinical trial. CONCLUSIONS: The superiority of porous HAp/Col for bone regeneration in comparison to an established porous β-TCP was confirmed. Although the incidence of side effects associated with the porous HAp/Col implant was higher than that in the β-TCP group, no serious adverse events occurred that resulted in rejection of the implants.
Authors: Ibrahim Fatih Cengiz; Hélder Pereira; Laura de Girolamo; Magali Cucchiarini; João Espregueira-Mendes; Rui L Reis; Joaquim Miguel Oliveira Journal: J Exp Orthop Date: 2018-05-22