Efficacy and safety of porous hydroxyapatite/type 1 collagen composite implantation for bone regeneration: A randomized controlled study

Shinichi Sotome, Keisuke Ae, Atsushi Okawa, Masafumi Ishizuki, Hideo Morioka, Seiichi Matsumoto, Takashi Nakamura, Satoshi Abe, Yasuo Beppu, Kenichi Shinomiya

Research output: Contribution to journalArticle

19 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)373-380
Number of pages8
JournalJournal of Orthopaedic Science
Volume21
Issue number3
DOIs
Publication statusPublished - 2016 May 1

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Bone Regeneration
Durapatite
Collagen Type I
Collagen
Safety
Nonparametric Statistics
Bone Substitutes
Bone Fractures
Incidence
Autografts
Hematologic Tests
Swine
Observation
X-Rays
Clinical Trials
Bone and Bones

ASJC Scopus subject areas

  • Medicine(all)
  • Orthopedics and Sports Medicine

Cite this

Efficacy and safety of porous hydroxyapatite/type 1 collagen composite implantation for bone regeneration : A randomized controlled study. / Sotome, Shinichi; Ae, Keisuke; Okawa, Atsushi; Ishizuki, Masafumi; Morioka, Hideo; Matsumoto, Seiichi; Nakamura, Takashi; Abe, Satoshi; Beppu, Yasuo; Shinomiya, Kenichi.

In: Journal of Orthopaedic Science, Vol. 21, No. 3, 01.05.2016, p. 373-380.

Research output: Contribution to journalArticle

Sotome, S, Ae, K, Okawa, A, Ishizuki, M, Morioka, H, Matsumoto, S, Nakamura, T, Abe, S, Beppu, Y & Shinomiya, K 2016, 'Efficacy and safety of porous hydroxyapatite/type 1 collagen composite implantation for bone regeneration: A randomized controlled study', Journal of Orthopaedic Science, vol. 21, no. 3, pp. 373-380. https://doi.org/10.1016/j.jos.2016.01.007
Sotome, Shinichi ; Ae, Keisuke ; Okawa, Atsushi ; Ishizuki, Masafumi ; Morioka, Hideo ; Matsumoto, Seiichi ; Nakamura, Takashi ; Abe, Satoshi ; Beppu, Yasuo ; Shinomiya, Kenichi. / Efficacy and safety of porous hydroxyapatite/type 1 collagen composite implantation for bone regeneration : A randomized controlled study. In: Journal of Orthopaedic Science. 2016 ; Vol. 21, No. 3. pp. 373-380.
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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.",
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T2 - A randomized controlled study

AU - Sotome, Shinichi

AU - Ae, Keisuke

AU - Okawa, Atsushi

AU - Ishizuki, Masafumi

AU - Morioka, Hideo

AU - Matsumoto, Seiichi

AU - Nakamura, Takashi

AU - Abe, Satoshi

AU - Beppu, Yasuo

AU - Shinomiya, Kenichi

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