Osteoregenerative efficacy of a novel synthetic, resorbable Ca/P/S-based bone graft substitute in intra- and peri-articular fractures: a brief medical image-based report

Abstract

Background: When a fracture goes into or around a joint, it usually damages the cartilage at the ends of bones and other joint tissue. As a result, the affected joints are prone to traumatic arthritis, leading to stiffness. Repairing bone damage, maintaining joint integrity, and avoiding subchondral and metaphyseal defects caused by comminuted fractures is often a great challenge for orthopedic surgeons. Tissue engineering of synthetic bone substitutes has proven beneficial to the attachment and proliferation of bone cells, promoting the formation of mature tissues with sufficient mechanical strength and has become a promising alternative to autograft methods. The purpose of this study is to retrospectively evaluate the clinical outcome and efficacy of a novel synthetic, highly biocompatible, and fully resorbable Ca/P/S-based bone substitute based on medical image findings.

Materials and methods: A synthetic, inorganic and highly porous Ca/P/S-based bone-substituting material (Ezechbone® Granule, CBS-400) has been developed by National Cheng-Kung University. We collected fourteen cases of complex intra- and peri-articular fractures with Ezechbone® Granule bone grafting between 2019/11 and 2021/11. We studied the evidence of bone healing by reviewing, interpreting and analyzing the medical image recordings.

Results: In the present study, CBS-400 was observed to quickly integrate into surrounding bone within three weeks after grafting during the initial callus formation of the early stage of repair. All of these cases healed entirely within three months. In addition, the patient may return to daily life function after 3.5 months of follow-up and rehabilitation treatment.

Conclusions: Ezechbone® Granule CBS-400 was proved capable of promoting bone healing and early rehabilitation to prevent soft tissue adhesions and joint contractures. Moreover, it has a high potential for avoiding ectopic bone formation or abnormal synostosis.

Trial registration: The Institutional Review Board at National Cheng Kung University Hospital (NCKUH) approved the study protocol (A-ER-109-031, 3-13-2020).

Keywords: Inorganic bone substitute; Intra-articular fracture; Osteoregneration; Peri-articular fracture.

Fig. 1

The nidus-like appearance (white arrow) in the X-ray indicates a primary fusion of the bone substitute and its close contact with the surrounding bone

Fig. 2

The X-ray reveals a shrinkage of the nidus-like lesion (white arrow) accompanied with initial bone callus formation

Fig. 3

The X-ray-revealed fill-full of the nidus-like lesion (white arrow) in bone graft area demonstrates well healing of the bone

Fig. 4

The X-ray shows that the bone substitute material was scattered in the soft tissue around the bone graft area and around the adjacent joint due to the treatment process (left). These implant residues were entirely absorbed (white arrow) within two months after implantation (right)

Fig. 5

Typical examples demonstrate poor resorbability (A, B) and ectopic bone formation or abnormal synostosis (C) (white arrows) often observed in many commercial brands of synthetic bone graft