Abstract

This study evaluated the safety and efficacy of a novel hyper-crosslinked carbohydrate polymer (HCCP) for the repair of critical-sized bone defects in comparison to two alternative treatments: autologous bone and poly(lactide-co-glycolide) with hyaluronic acid (PLGA/HA). Bilateral critical-sized defects were created in the lateral femoral condyles of skeletally mature New Zealand White rabbits, and they were subsequently implanted with HCCP, PLGA/HA, or autologous bone in a randomized manner. Clinical and behavioral observations were made daily, and radiological and histopathological evaluations were performed at 4, 10, and 16 weeks postimplantation. Defects implanted with HCCP showed progressive bone regeneration and bridging of the defect without adverse histological events. No signs of infection or inflammation associated with the implant material were observed in all animals that received HCCP implantation. A radiographic assessment performed at 16 weeks post-implantation showed significantly higher bone density and volume in defects implanted with HCCP compared to PLGA/HA. No statistically significant difference was observed in bone density and volume between HCCP and autologous bone. These findings demonstrate that HCCP is biocompatible, osteoconductive, and capable of promoting bone regeneration in vivo; therefore, it is suitable for both tissue engineering and the repair of critical-sized bone defects.

Highlights

  • Bone regeneration in vivo, as a treatment for bone defects such as those caused by fractures or osteotomies, remains a challenge for clinicians and patients, especially high-risk patients.[1]

  • Complete soaking of hyper-crosslinked carbohydrate polymer (HCCP) with blood/bone marrow was observed immediately after implantation compared with PLGA/hyaluronic acid (HA), which showed incomplete uptake of blood/bone marrow (Fig. 1)

  • Animals implanted with HCCP showed subcutaneous abscess (n = 1) and non-weight bearing behavior (n = 2) during the entire course of the study compared with PLGA/ HA and autologous bone

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Summary

Introduction

As a treatment for bone defects such as those caused by fractures or osteotomies, remains a challenge for clinicians and patients, especially high-risk patients.[1]. The standard treatment transitioned away from the use of allograft bone due to the risk of transmissible diseases, immune rejection by the host, and lot-to-lot variations.[2,3] Autologous bone grafting became the gold standard due to the osteoinductive properties, reduced risk of disease transmission, and the inherent biocompatibility of a patient’s own bone. More than 200,000 bone repair procedures are performed in the United States each year that utilize autologous bone harvested from the iliac crest[4] as a source of graft material. Donor site morbidity, including infection, iliac wing fracture, loss of mobility, and chronic pain,[5,6] as well as patient-specific complications, such as insufficient or nonviable donor bone, are among the most serious drawbacks of autologous bone harvest procedures.[7] The significant limitations a Plamena M.

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