Effective management of bone fractures with the IlluminOss® photodynamic bone stabilization system: initial clinical experience from the European Union registry

Abstract

The IlluminOss® system (IS) uses a light-curable polymer contained within an inflatable balloon catheter, forming a patient customized intramedullary implant. A registry was established in Germany and The Netherlands to prospectively collect technical and clinical outcomes in patients treated with IS for fractures of the phalange, metacarpal, radius, ulna, distal radius, fibula, clavicle and/or olecranon. Humeral, femoral, tibial and pelvic fractures were included under compassionate use. Procedural success included successful placement of the device at the target fracture site and achievement of fracture stabilization. Clinical and radiographic assessments were made postoperatively through 12 months. One hundred thirty two patients (149 fractures) were enrolled with most fractures (85%) resulting from low-energy trauma. Simple fractures predominated (47%) followed by complex (23%) and wedge (16%) fractures. Procedural success was achieved in all patients and no implants required removal or revision. Normal range of motion was realized in 87% of fractures. Radiographically, there was substantial cortical bridging, total dissolution of the fracture line, and complete fracture healing. Across a variety of fracture types, the IS provides a safe and effective approach for rapid healing and functional recovery.

Intramedullary Stabilization of Pubic Ramus Fractures in Elderly Patients With a Photodynamic Bone Stabilization System (IlluminOss)

“…Clinical and experimental studies present adequate results and safe application after the treatment of long bone osteoporotic fractures with this photodynamic stabilization device. 1-4…”

A hybrid treatment modality of a subtrochanteric femoral fracture in a patient with osteoporosis due to a renal Fanconi syndrome: a case report

“…Therefore, we reinforced the femoral shaft using Illuminoss before fixation with a DHS. This fixation is comparable to traditional intramedullary fixation [ 4 ]. Placement of the omega 3 implant was possible, due to the immediate stability that the polymer provides.…”

Finite Element Analysis Study of Prototype of a Novel Intramedullary Injectable Bioresorbable Polymer Fixator versus a Volar Plate for Surgical Treatment of Distal Radius Fractures

“…Thus, research continues for alternative surgical modalities to volar plating, such as the notional one (injectable bioresorbable polymer fixator) presented in the present work. It is pointed out that although there are balloon fracture reduction systems in current clinical use [5] [19], the present fixator differs from these systems in two ways. First, some of the current systems are not specifically designed for fixation of DRFs; thus, for example, they have been used in fixation of calcaneal fractures [19].…”

“…First, some of the current systems are not specifically designed for fixation of DRFs; thus, for example, they have been used in fixation of calcaneal fractures [19]. Second, and, more importantly, in many cases, reduction of the fracture by these current systems is followed by injection of a bone cement (usually, calcium phosphate cement) or an adjunctive hardware [5], whereas, in contrast, as envisaged, the present fixator will not require any such support. Both the type and location of the simulated fracture pattern we used in the study (extra-articular metaphyseal fracture of the distal radius, with a planar gap of 4 mm, positioned 25 mm below the distal surface) is clinically relevant because there are reports of patients presenting with this fracture pattern in emergency rooms, trauma centers, and hospitals [20].…”

“…There is a very large and diverse assortment of treatment/management modalities for these fractures. Examples are cast immobilization only; closed reduction and fixation with percutaneous Kirschner wires only; and open reduction and internal fixation with a volar locking plate, dorsal locking plate, percutaneous Kirschner wires in combination with a non-bridging cross-pin fixator, a system comprising an expandable intramedullary cage and fragment-specific screw fixation, intramedullary nailing, or a photodynamic system (comprising a light-curable polymer contained in an inflatable balloon catheter) [3] [4] [5]. For a given fracture type, there is lack of consensus on the optimal treatment modality [4] [6] [7] [8] [9].…”