title: Analyzing the behavior of a porous nano-hydroxyapatite/polyamide 66 (n-HA/PA66) composite for healing of bone defects.
abstract: The aim of this study was to analyze the behavior of the porous nano-hydroxyapatite/polyamide 66 (n-HA/PA66) composite grafted for bone defect repair through a series of biological safety experiments, animal experiments, and a more than 5-year long clinical follow-up. The biological safety experiments, carried out in accordance with the Chinese Guo Biao and Tolerancing (GB/T)16886 and GB/T16175, revealed that porous n-HA/PA66 composite had no cytotoxicity, no sensitization effect, no pyrogenic reaction, and that its hemolysis rate was 0.59% (less than 5%). Rabbit models of tibia defects with grafted porous n-HA/PA66 composite were established. After 2 weeks, the experiment showed that osteogenesis was detected in the porous n-HA/PA66 composite; the density of new bone formation was similar to the surrounding host bone at 12 weeks. After 26 weeks, the artificial bone rebuilt to lamellar bone completely. In the clinical study, a retrospective review was carried out for 21 patients who underwent serial radiographic assessment after treatment with porous n-HA/PA66 composite grafts following bone tumor resection. All wounds healed to grade A. No postoperative infections, delayed deep infection, nonspecific inflammation, rejection, or fractures were encountered. At a mean follow-up of 5.3 years, the mean Musculoskeletal Tumor Society's (MSTS) 93 score was 29.3 points (range: 28-30 points) and mean radiopaque density ratio was 0.77±0.10. The radiologic analysis showed that porous n-HA/PA66 composite had been completely incorporated with the host bone about 1.5 years later. In conclusion, this study indicated that the porous n-HA/PA66 composite had biological safety, and good biocompatibility, osteoinduction, and osseointegration. Thus, the porous n-HA/PA66 composite is an ideal artificial bone substitute and worthy of promotion in the field.
authors: Department of Orthopedics, West China Hospital, Chengdu, People's Republic of China.
authors: Yan
authors: Y
authors: Xiong
authors: Department of Orthopedics, West China Hospital, Chengdu, People's Republic of China.
authors: Cheng
authors: C
authors: Ren
authors: Department of Orthopedics, West China Hospital, Chengdu, People's Republic of China.
authors: Bin
authors: B
authors: Zhang
authors: Department of Orthopedics, West China Hospital, Chengdu, People's Republic of China.
authors: Hongsheng
authors: H
authors: Yang
authors: Department of Orthopedics, West China Hospital, Chengdu, People's Republic of China.
authors: Yun
authors: Y
authors: Lang
authors: Department of Orthopedics, West China Hospital, Chengdu, People's Republic of China.
authors: Li
authors: L
authors: Min
authors: Department of Orthopedics, West China Hospital, Chengdu, People's Republic of China.
authors: Wenli
authors: W
authors: Zhang
authors: Department of Orthopedics, West China Hospital, Chengdu, People's Republic of China.
authors: Fuxing
authors: F
authors: Pei
authors: School of Physical Science and Technology, Chengdu, People's Republic of China.
authors: Yonggang
authors: Y
authors: Yan
authors: School of Physical Science and Technology, Chengdu, People's Republic of China.
authors: Hong
authors: H
authors: Li
authors: Department of Oral Implant, West China College of Stomatology, Sichuan University, Chengdu, People's Republic of China.
authors: Anchun
authors: A
authors: Mo
authors: Department of Orthopedics, West China Hospital, Chengdu, People's Republic of China.
authors: Chongqi
authors: C
authors: Tu
authors: Department of Orthopedics, West China Hospital, Chengdu, People's Republic of China.
authors: Hong
authors: H
authors: Duan
mesh_terms: D000293:Adolescent; D000328:Adult; D000818:Animals; D001847:Bone Diseases / Q000000981:diagnostic imaging / Q000628:therapy; D001859:Bone Neoplasms / Q000000981:diagnostic imaging / Q000628:therapy; D018786:Bone Substitutes / Q000008:administration & dosage* / Q000737:chemistry; D016025:Bone Transplantation / Q000379:methods; D017886:Durapatite / Q000008:administration & dosage* / Q000737:chemistry; D005260:Female; D006801:Humans; D008297:Male; D008422:Materials Testing; D008875:Middle Aged; D053761:Nanocomposites / Q000008:administration & dosage* / Q000737:chemistry; D050997:Nanomedicine; D009757:Nylons / Q000737:chemistry; D016348:Osseointegration; D016062:Porosity; D011817:Rabbits; D011859:Radiography; D012189:Retrospective Studies; D055815:Young Adult
chemical_list: D018786:Bone Substitutes; D009757:Nylons; D017886:Durapatite
keywords: artificial bone materials; biomaterial; bone defects healing; bone grafting; porous n-HA/PA66 composite (n-HAPA66)