Safety and performance of a novel synthetic biomimetic scaffold for iliac crest defect reconstruction during surgical treatment of pelvic girdle pain: a first-in-human trial.

Introduction:

Surgical treatment of pelvic girdle pain (PGP) involves arthrodesis of sacroiliac (SI) and pubic symphysis joints. Fusion of pubic symphysis involves the implantation of an autologous iliac crest tricortical graft harvested from the iliac crest. The objective was to assess the safety of a novel synthetic graft substitute (b.Bone) for iliac crest reconstruction and to evaluate the results of PGP surgical treatment.

Sources of data:

Consecutive participants undergoing pelvic fusion and requiring iliac crest reconstruction were enrolled and followed-up for 12 months in a prospective first-in-human clinical investigation. Adverse events were documented, and health-related quality of life was evaluated using EuroQol-5D-5L questionnaire. Iliac crest defect healing was evaluated by the Modified Lane and Sandhu radiological scoring system. In addition, relevant published peer-reviewed scientific articles identified from PubMed.

Areas of agreement:

The EQ-5D-5L scores improved steadily reaching the highest point at 365 days. By 365 days complete healing of the bone defect was observed.

Areas of controversy:

The management of PGP remains challenging with mixed results reported in the literature.

Growing points:

While there is lack of consensus on how to manage PGP, the present study shows improved outcomes at one year following surgery. The synthetic b.Bone scaffold is a safe option with good healing outcomes for iliac crest defect reconstruction.

Areas timely for developing research:

Although b.Bone synthetic scaffold found to be safe, further studies reporting on surgical treatment of PGP are required to confirm the findings in comparative trials.

Preliminary osteogenic and antibacterial investigations of wood derived antibiotic-loaded bone substitute for the treatment of infected bone defects

Introduction: The development of reliable treatments for infected or potentially infected bone loss resulting from open fractures and non-unions is extremely urgent, especially to reduce the prolonged courses of antimicrobial therapy to which affected patients are subjected. Numerous bone graft substitutes have been used over the years, but there are currently no effective solutions to treat critical bone loss, especially in the presence of infection. The present study evaluated the use of the biomorphic calcium phosphate bone scaffold b. Bone™, based on a next-generation resorbable biomimetic biomaterial, in bone reconstruction surgery in cases of infection. Methods: Using an “in vitro 3D bone fracture model” to predict the behavior of this drug delivery system during critical bone loss at an infected (or potentially infected) site, the effects of scaffolds loaded with gentamicin or vancomycin on the viability and differentiation capacity of human mesenchymal stem cells (hMSCs) were evaluated. Results: This scaffold, when loaded with gentamicin or vancomycin, exhibits a typical drug release curve that determines the inhibitory effects on the growth of Staphylococcus aureus, Enterococcus faecalis, and Escherichia coli, as well as relative biofilm formation. Discussion: The study demonstrates that b.bone scaffolds can effectively address key challenges in orthopedic surgery and patient care by inhibiting bacterial growth and biofilm formation through rapid, potent antibiotic release, reducing the risk of treatment failure due to resistance, and providing a promising solution for bone infections and improved patient outcomes. Future studies could explore the combination of different antibiotics on these scaffolds for more tailored and effective treatments against post-traumatic osteomyelitis pathogens.

The use of a new grafting material (b.Bone™) for the management of severely depressed tibial plateau fractures: preliminary report of three cases

Tibial plateau fractures are often complex injuries that result from high-energy trauma affecting the articular congruity of the knee. Managing tibial plateau fractures can be challenging because of severe depression of the subchondral cancellous bone and concomitant cartilage injury. Bone substitutes are commonly used to fill such defects as part of the surgical treatment of tibial plateau fractures. We describe three cases of tibial plateau fractures managed with a synthetic bone substitute (b.Bone™, GreenBone ORTHO S.p.A Faenza, Italy) with a highly interconnected and porous 3D structure to mimic the hierarchical architecture and morphology of natural human bone

Biological aspects to enhance fracture healing

The ability to enhance fracture healing is paramount in modern orthopaedic trauma, particularly in the management of challenging cases including peri-prosthetic fractures, non-union and acute bone loss. Materials utilised in enhancing fracture healing should ideally be osteogenic, osteoinductive, osteoconductive, and facilitate vascular in-growth. Autologous bone graft remains the gold standard, providing all of these qualities. Limitations to this technique include low graft volume and donor site morbidity, with alternative techniques including the use of allograft or xenograft. Artificial scaffolds can provide an osteoconductive construct, however fail to provide an osteoinductive stimulus, and frequently have poor mechanical properties. Recombinant bone morphogenetic proteins can provide an osteoinductive stimulus; however, their licencing is limited and larger studies are required to clarify their role. For recalcitricant non-unions or high-risk cases, the use of composite graft combining the above techniques provides the highest chances of successfully achieving bony union.

Scaffold Guided Bone Regeneration for the Treatment of Large Segmental Defects in Long Bones

Bone generally displays a high intrinsic capacity to regenerate. Nonetheless, large osseous defects sometimes fail to heal. The treatment of such large segmental defects still represents a considerable clinical challenge. The regeneration of large bone defects often proves difficult, since it relies on the formation of large amounts of bone within an environment impedimental to osteogenesis, characterized by soft tissue damage and hampered vascularization. Consequently, research efforts have concentrated on tissue engineering and regenerative medical strategies to resolve this multifaceted challenge. In this review, we summarize, critically evaluate, and discuss present approaches in light of their clinical relevance; we also present future advanced techniques for bone tissue engineering, outlining the steps to realize for their translation from bench to bedside. The discussion includes the physiology of bone healing, requirements and properties of natural and synthetic biomaterials for bone reconstruction, their use in conjunction with cellular components and suitable growth factors, and strategies to improve vascularization and the translation of these regenerative concepts to in vivo applications. We conclude that the ideal all-purpose material for scaffold-guided bone regeneration is currently not available. It seems that a variety of different solutions will be employed, according to the clinical treatment necessary

Bone defect filling with a novel rattan-wood based not-sintered hydroxyapatite and beta-tricalcium phosphate material (b. Bone™) after tricortical bone graft harvesting – A consecutive clinical case series of 9 patients

Harvesting of tricortical bone graft from the iliac crest is an integral part of bone defect reconstruction in orthopaedic surgery. There are several options for filling the iliac crest defect area to avoid hematoma, pain, hernias and cosmetic issues, including different gelatin-based and other alternative biomaterials. Recently, a novel rattan-wood based not-sintered hydroxyapatite and beta-tricalcium phosphate material (b.Bone™, GreenBone ORTHO S.p.A Faenza, Italy) was shown to promote bone healing in an experimental setting. The goal of the current work is to report clinical and radiographical outcomes of a consecutive case series of 9 patients with defect filling at the iliac crest with this novel scaffold biomaterial after tricortical bone graft harvesting with a minimum follow-up of 6 months. All 9 patients (8 male, 1 female) with an average age of 42.7 years (range: 18-76 years) had tricortical bone graft harvesting from the iliac crest for different reconstructive procedures at the extremities and received blocks of the biomaterial with an average size of 26.3 × 16.8 × 10 mm (length, height, width; range: 15 × 15 × 10 to 40 × 20 × 10 mm). Intraoperative handling of the biomaterial was easy and the blocks could be customized to the individual size of the defect with standard surgical instruments and were press-fitted into the defect. All 9 patients showed uneventful wound healing at the iliac crest and 7 patients reported no pain (VAS: 0) and two patients only mild pain (VAS:1 and VAS:3) after an average follow-up of 9.8 months (range: 6-16 months). There was no post-operative hematoma, surgical revision or other implant-related complications at the iliac crest. In all patients, good radiographical integration without dislocation of the implant and good bony integration was observed. The use of this novel biomaterial for iliac crest defect filling was associated with good clinical and radiographical outcomes after an average follow-up of 9.8 months.

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