Outcome after treatment of distal radius fractures in the elderly using the IlluminOss® System.

PURPOSE: Distal radius fractures are very common and account for approximately 17% of all fractures treated. Multiple treatment methods are available to treat these fractures, both operative and nonoperative. This study aimed at evaluating the functional and clinical outcomes after treatment of distal radius fractures with the IlluminOss® System in adult patients. METHODS: A retrospective case series was performed in a single-level two-trauma center. All consecutive adult patients with a distal radius fracture, treated with the IlluminOss® System between 01 August 2012 and 15 August 2015, were included in this study. Baseline patient characteristics and clinical data were retrospectively extracted from the medical records. Radial inclination, volar/dorsal tilt, ulnar variance, and radial length were measured on the latest available standard radiographs. In addition, patients were prospectively subjected to physical examination and were asked to complete the Disabilities of the Arm, Shoulder, and Hand, Patient-Rated Wrist Evaluation, and Short Form-36 questionnaires. RESULTS: Twenty-six patients with 31 distal radius fractures were included. The median age at time of trauma was 77 years and 96% were females. Five patients developed a total of seven complications. Due to persisting pain one reoperation was performed, removing a small prominent part of the implant. Both patient-reported outcome scores and radiographic results were good to excellent. CONCLUSIONS: The IlluminOss® System is a feasible option to treat distal radius fractures with seemingly good clinical and functional outcome. One out of seven complications required surgical intervention. These outcomes justify more detailed prospective research.

Epidemiology of injuries, treatment (costs) and outcome in burn patients admitted to a hospital with or without dedicated burn centre (Burn-Pro): protocol for a multicentre prospective observational study.

INTRODUCTION: The Emergency Management of Severe Burns (EMSB) referral criteria have been implemented for optimal triaging of burn patients. Admission to a burn centre is indicated for patients with severe burns or with specific characteristics like older age or comorbidities. Patients not meeting these criteria can also be treated in a hospital without burn centre. Limited information is available about the organisation of care and referral of these patients. The aims of this study are to determine the burn injury characteristics, treatment (costs), quality of life and scar quality of burn patients admitted to a hospital without dedicated burn centre. These data will subsequently be compared with data from patients with<10% total bodysurface area (TBSA) burned who are admitted (or secondarily referred) to a burn centre. If admissions were in agreement with the EMSB, referral criteria will also be determined. METHODS AND ANALYSIS: In this multicentre, prospective, observational study (cohort study), the following two groups of patients will be followed: 1) all patients (no age limit) admitted with burn-related injuries to a hospital without a dedicated burn centre in the Southwest Netherlands or Brabant Trauma Region and 2) all patients (no age limit) with<10% TBSA burned who are primarily admitted (or secondarily referred) to the burn centre of Maasstad Hospital. Data on the burn injury characteristics (primary outcome), EMSB compliance, treatment, treatment costs and outcome will be collected from the patients' medical files. At 3 weeks and at 3, 6 and 12 months after trauma, patients will be asked to complete the quality of life questionnaire (EuroQoL-5D), and the patient-reported part of the Patient and Observer Scar Assessment Scale (POSAS). At those time visits, the coordinating investigator or research assistant will complete the observer-reported part of the POSAS. ETHICS AND DISSEMINATION: This study has been exempted by the medical research ethics committee Erasmus MC (Rotterdam, The Netherlands). Each participant will provide written consent to participate and remain encoded during the study. The results of the study are planned to be published in an international, peer-reviewed journal. TRIAL REGISTRATION NUMBER: NTR6565.

Effective Management of Bone Fractures with the Illuminoss® Photodynamic Bone Stabilization System: Initial Clinical Experience from the European Union Registry.

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.

Functional recovery after treatment of extra-articular distal radius fractures in the elderly using the IlluminOss® System (IO-Wrist); a multicenter prospective observational study.

BACKGROUND: Approximately 17 % of all fractures involve the distal radius. Two-thirds require reduction due to displacement. High redislocation rates and functional disability remain a significant problem after non-operative treatment, with up to 30 % of patients suffering long-term functional restrictions. Whether operative correction is superior to non-operative treatment with respect to functional outcome has not unequivocally been confirmed. The IlluminOss® System was introduced in 2009 as a novel, patient-specific, and minimally invasive intramedullary fracture fixation. This minimally invasive technique has a much lower risk of iatrogenic soft tissue complications. Because IlluminOss® allows for early mobilization, it may theoretically lead to earlier functional recovery and ADL independence than non-operative immobilization. The main aim of this study is to examine outcome in elderly patients who sustained a unilateral, displaced, extra-articular distal radius fracture that was treated with IlluminOss®. METHODS/DESIGN: The design of the study will be a multicenter, prospective, observational study (case series). The study population comprises elderly (60 years or older; independent in activities of daily living) with a unilateral, displaced, extra-articular distal radius fracture (AO/OTA type 23-A2 and A3) that after successful closed reduction was fixed within 2 weeks after the injury with IlluminOss®. Critical elements of treatment will be registered, and outcome will be monitored until 1 year after surgery. The Disabilities of the Arm, Shoulder, and Hand score will serve as primary outcome measure. The Patient-Rated Wrist Evaluation score, level of pain, health-related quality of life (Short Form-36 and EuroQoL-5D), time to ADL independence, time to activities/work resumption, range of motion of the wrist, radiological outcome, and complications are secondary outcome measures. Health care consumption and lost productivity will be used for a cost analysis. The cost analysis will be performed from a societal perspective. Descriptive data will be reported. DISCUSSION: The results of this study will provide evidence on the effectiveness of operative treatment of patients who sustained an extra-articular distal radius fracture with the IlluminOss® System, using clinical, patient-reported, and societal outcomes. TRIAL REGISTRATION: The study is registered at the Netherlands Trial Register ( NTR5457 ; 29-sep-2015).

Displaced proximal humeral fractures: intramedullary nailing versus conservative treatment.

INTRODUCTION: A variety of different treatment options are available for displaced three- or four-part fractures. In a retrospective cohort study we evaluated the results of intramedullary nailing with the ACE nail and conservative treatment of displaced proximal humeral fractures. MATERIALS AND METHODS: Twenty-four patients suffered a neer 4, 5 or 6 proximal humeral fracture who were treated with intramedullary nailing. Sixteen patients received conservative treatment for their Neer 4, 5 or 6 fracture. RESULTS: Taking critical remarks in consideration, the results of intramedullary nailing are not very satisfactory compared to the conservative-treated group. However functional results of our operative group are comparable to those from other studies in literature. CONCLUSION: Displaced three- or four-part proximal humeral fractures can be treated by intramedullary nailing. Familiarity with the fracture deformity and experience with the surgical techniques are critical for successful operative treatment outcome. Most complications in the operative treatment group can be avoided; inadequate reduction can lead to wrong insertion place with secondary problems (dislocation and subacromial impingement). Also future improvements in osteosynthesis like angle stable screw fixation (osteoporosis) and minimally invasive device will probably decrease the complication rate.