1. Use of OP1: present situation 1.1 Tibial pseudoarthrosis. The work by Friedlander can be considered golden standard about the clinical application. It is a prospective, randomized clinical trial comparing OP-1 with fresh bone autograft. Results of the two techniques are similar under the clinical and radiographical point of view( 1.2 Australian study of 163 patients with amputation risk was done an attempt with OP1 application, before of his commercialisation. In these cases the drug demonstrated to be very efficacious( 1.3 Concerning the fresh fractures, experience is limited to prospective, randomised, multicenter clinical trial. The conclusions are a reduction of consolidation delay and the number of reoperation in the OP1 treated group versus the not treated one( 2. In the I Orthopaedic Clinic of Turin University (UOSD Muscle-Skeletal Traumatology and External Fixation) guide lines for OP1 application are: 2.1 Delayed union of the docking point in pseudoar-throsis of long bones treated with the Ilizarov technique. OP1 is also used if traditional techniques are not suitable for application 2.2 Traditional techniques failure 2.3 First treatment in very difficult cases of limb reconstruction and bone nonunion 3. From 30/09/2002 till 27/09/2004, 19 patients have been treated with OP1. Middle age is 38 years (range 22–65). Before last intervention, middle number of operation is 6,5 (range 3–26) with middle time treatment of 4 years (range 1–31). 12 healed, 5 are under treatment and 2 are failure (osteomyelitis relapse). 10 tibias, 7 femurs, 1 humerus and 1 forearm were treated. The middle time of healing was 4 months (range 2–6). Healing has been evaluated by clinical and radiographical point of view (handly evaluation of stability, function recuperation and image of bone consolidation). Radiographic images of bone consolidation are not strictly correlated with clinical stability and function recovery. 4. Conclusion: 4.1 The series is strictly observational. However results are satisfying, given the complexity of treated cases. More prospective randomised double blind clinical studies, and drug cost decrease are necessary to extend the indications for OP1 application.
Commercial aviation has recognized since long time that the so called “human factor” is the main responsible for the majority of accidents or near-accidents, which are always reported in aviation but almost never in medicine. Therefore I strongly support the idea that we could much learn from aviation in order to cope with the major cause of our accidents. Like airmen, pilots, air traffic controllers and so on, we also make errors. The first step to reduce the burden of our errors is to be able to admit them in order to analyse their causes, which up to now we are unable to do. Only one medical journal, the Lancet, has started to publish our errors. But beware not to make confusion between, complication, negative outcome and medical error. The “human factor” must not be understood as human error; on the contrary the human factor is related to the majority of accidents, where the human error is only a minor and final cause. To understand how “human factors” can play a role in determining the “accident”, we must first distinguish between active and latent failures. Active failures are unsafe acts committed by those at the sharp end of the system: the pilot, air traffic controller, anaesthetist, surgeon. Latent failures arise from fallible decisions, usually taken within the higher levels of the organization or within society at large. A clear example is the crash of the SAS aircraft in Milano Linate with a small aircraft of the general aviation on the same runaway. No ground radar was available and the fog made the rest. But only the “sharp end” of the system, i.e. the traffic controllers paid for their error, not those responsible for not buying the ground radar. We must develop a new culture of error but this will remain difficult until our legal systems do not change their approach towards negative outcomes. This vicious circle needs to be cut for the benefit of all, patients and doctors.
The SEM analyses indicated that the PEs surface which was directly in contact with bone shows an anomalous degradation. The surface looks as it has been corroded or “bitten” and its morphology is significantly different from that of surfaces abraded either in vivo or in vitro.
Negative outcomes, accidents and complications are unavoidable. In surgery as in aviation a major role is played by human factors contributing to 30 to 90 per cent of accidents. However in aviation accidents and near-accidents are investigated and all errors are reported. Surgical errors and near-accidents are never reported nor investigated and no lesson can be learned.
The choice of treatment for open fractures is conditioned by the care of bone and soft tissue. Grade I open fractures can be treated as closed fractures, according to the centre’s protocol. In Grade II open fractures skin wounds must be left open, and the suture should be delayed for at least a week. Most authors perform fixation by means of intramedullary nails. In our opinion, external fixation is the best choice in these cases. The skin cannot be closed in Grade III open fractures, and the basic point of treatment is adequate surgical debridement. The fixation must be done by external fixation. To achieve the treatment in an emergency situation, the device to be used must be quick and simple like a monolateral device that can be changed into a more complex one, such as an Ilizarov. The Ilizarov technique uses distractional osteogenesis that can fill bone and soft tissue loss without further bone or soft tissue grafting. Following these general guidelines, each district has its own particular approach to treating open fractures. Internal fixation by DCP plates is always indicated for forearm fractures. For a humerus fracture, simple direct shortening and external fixation can fill bone loss. Patients with fractures of the femur usually have multiple injuries. The problem is to provide a quick fixation in order to allow for easier intensive care. External fixation is the most indicated technique.
The choice of treatment for open fractures is conditioned by the care of bone and soft tissue. Grade I open fractures can be treated as closed fractures, according to the centre’s protocol. In Grade II open fractures skin wounds must be left open, and the suture should be delayed for at least a week. Most authors perform fixation by means of intramedullary nails. In our opinion, external fixation is the best choice in these cases. The skin cannot be closed in Grade III open fractures, and the basic point of treatment is adequate surgical debridement. The fixation must be done by external fixation. To achieve the treatment in an emergency situation, the device to be used must be quick and simple like a monolateral device that can be changed into a more complex one, such as an Ilizarov. The Ilizarov technique uses distractional osteogenesis that can fill bone and soft tissue loss without further bone or soft tissue grafting. Following these general guidelines, each district has its own particular approach to treating open fractures. Internal fixation by DCP plates is always indicated for forearm fractures. For a humerus fracture, simple direct shortening and external fixation can fill bone loss. Patients with fractures of the femur usually have multiple injuries. The problem is to provide a quick fixation in order to allow for easier intensive care. External fixation is the most indicated technique.