Safety and Performance of Bone-Anchored Prostheses in Persons with a Transfemoral Amputation: A 5-Year Follow-up Study.

BACKGROUND: For almost 30 years, bone-anchored prostheses have offered an alternative solution to prosthetic sockets by attaching the artificial limb directly to the femoral residuum by means of an osseointegration implant. Osseointegration implant surgery was introduced in our center in 2009. The aim of the present study is to report on safety, prosthesis-wearing time, and health-related quality-of-life (HRQoL) for patients with femoral bone-anchored prostheses during a 5-year follow-up period. METHODS: All patients who underwent implantation of a press-fit osseointegration implant between May 2009 and November 2013 were eligible for the present study. Implantation was performed in 2 stages. Adverse events included infectious complications (grade 1 to 4), aseptic loosening, breakage, stoma-redundant tissue, and stoma hypergranulation. Prosthesis-wearing time and HRQoL were measured with the Questionnaire for Persons with a Transfemoral Amputation (Q-TFA) prosthetic use score and global score, respectively. RESULTS: Thirty-nine of 42 eligible patients were included. Thirty patients (77%) presented with some kind of infection (156 events in total), with 148 (95%) events being classified as grade 1 or 2 and 8 events (5%) being classified as grade 3; the latter 8 events occurred in 4 patients. There were no instances of septic loosening. The intramedullary stem of the osseointegration implant broke in 2 patients. In total, soft-tissue refashioning had to be done 30 times in 14 patients. The Q-TFA median prosthetic use and global scores improved significantly from 71 to 100 and from 33 to 75, respectively (p < 0.001). CONCLUSIONS: Despite the adverse events, patient prosthetic use and HRQoL improved significantly. Grade-1 and 2 infections were frequent but could mostly be treated with nonoperative measures. Most infections seemed to occur in the first 2 years and did not lead to deep infections. Two broken intramedullary stems were revised successfully. Current developments focus on reduction of infectious complications and prevention of osseointegration implant breakage. LEVEL OF EVIDENCE: Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.

Osseointegrated prosthesis for patients with an amputation : Multidisciplinary team approach in the Netherlands.

This article reviews the development of multidisciplinary osseointegration treatment in the Netherlands since its start in 2009. People experiencing limitations due to their socket prosthesis after a leg amputation present to the Radboud University Nijmegen Medical Centre for an osseointegration implant or "bone-anchored" prosthesis. In this article we share our experience with the first 100 patients regarding referral pattern, selection criteria, available osseointegration systems, preoperative planning, surgical treatment, the rehabilitation protocol, outcome measurement, revision surgery, and future developments.

Treatment of displaced intra-articular calcaneal fractures with closed reduction and percutaneous screw fixation.

BACKGROUND: Surgical treatment of displaced intra-articular fractures of the calcaneus is a standard procedure in many institutions. To avoid soft-tissue complications, several minimally invasive procedures have recently been introduced. The aim of this study was to assess the percutaneous treatment of displaced intra-articular calcaneal fractures with use of one of these techniques. METHODS: All patients who underwent percutaneous screw fixation according to the method of Forgon and Zadravecz between 1998 and 2006 were selected. Postoperative infections were recorded. During follow-up, pain, functional outcome, range of motion, and change in footwear were evaluated with the use of the American Orthopaedic Foot & Ankle Society (AOFAS) score and the Maryland Foot Score (MFS). All patients also completed a general health status form (Short Form-36 [SF-36]) and a visual analog scale (VAS) for patient satisfaction. Subsequent subtalar arthrodesis and the removal of irritating screws were performed when indicated. RESULTS: We reviewed the cases of thirty-seven patients who had a combined total of thirty-nine displaced intra-articular calcaneal fractures and a follow-up period of at least twenty-four months. Five wound infections occurred, two of which were superficial and three of which were deep. At a mean follow-up time of sixty-six months, the mean AOFAS and MFS scores were 84 and 86 points, respectively, of 100 possible points. The mean score on the SF-36 was 76 points, and the mean score on the visual analog scale for patient satisfaction was 7.9 points of 10 possible points. Twenty-nine patients (78%) were able to wear normal shoes. At the time of follow-up, subtalar arthrodesis had been performed in two patients and seventeen patients (46%) had undergone an uncomplicated removal of painful screws. No substantial correlation was found between the severity of the fracture (Sanders classification) or the quality of the reduction when correlated with functional outcome parameters. CONCLUSIONS: We consider the technique of Forgon and Zadravecz to be an excellent option for the treatment of displaced intra-articular calcaneal fractures in selected patients despite the frequent need for screw removal following fracture-healing.

Exsanguination in trauma: A review of diagnostics and treatment options.

Trauma patients with haemorrhagic shock who only transiently respond or do not respond to fluid therapy and/or the administration of blood products have exsanguinating injuries. Recognising shock due to (exsanguinating) haemorrhage in trauma is about constructing a synthesis of trauma mechanism, injuries, vital signs and the therapeutic response of the patient. The aim of prehospital care of bleeding trauma patients is to deliver the patient to a facility for definitive care within the shortest amount of time by rapid transport and minimise therapy to what is necessary to maintain adequate vital signs. Rapid decisions have to be made using regional trauma triage protocols that have incorporated patient condition, transport times and the level of care than can be performed by the prehospital care providers and the receiving hospitals. The treatment of bleeding patients is aimed at two major goals: stopping the bleeding and restoration of the blood volume. Fluid resuscitation should allow for preservation of vital functions without increasing the risk for further (re)bleeding. To prevent further deterioration and subsequent exsanguinations 'permissive hypotension' may be the goal to achieve. Within the hospital, a sound trauma team activation system, including the logistic procedure as well as activation criteria, is essential for a fast and adequate response. After determination of haemorrhagic shock, all efforts have to be directed to stop the bleeding in order to prevent exsanguinations. A simultaneous effort is made to restore blood volume and correct coagulation. Reversal of coagulopathy with pharmacotherapeutic interventions may be a promising concept to limit blood loss after trauma. Abdominal ultrasound has replaced diagnostic peritoneal lavage for detection of haemoperitoneum. With the development of sliding-gantry based computer tomography diagnostic systems, rapid evaluation by CT-scanning of the trauma patient is possible during resuscitation. The concept of damage control surgery, the staged approach in treatment of severe trauma, has proven to be of vital importance in the treatment of exsanguinating trauma patients and is adopted worldwide. When performing 'blind' transfusion or 'damage control resuscitation', a predetermined fixed ratio of blood components may result in the administration of higher plasma and platelets doses and may improve outcome. The role of thromboelastography and thromboelastometry as point-of-care tests for coagulation in massive blood loss is emerging, providing information about actual clot formation and clot stability, shortly (10min) after the blood sample is taken. Thus, therapy guided by the test results will allow for administration of specific coagulation factors that will be depleted despite administration with fresh frozen plasma during massive transfusion of blood components.

[Wrist pain following radial head fracture caused by a tear in the interosseous membrane (Essex-Lopresti lesion)]. / Pijn aan de pols na een radiuskopfractuur door bijkomende scheuring van de membrana interossea (laesie van Essex-Lopresti).

A 44-year-old multiple injured patient presented with several fractures including a dislocated, comminuted radial head fracture after a 4 meter fall from a ladder. He was treated with radial head resection. However, at routine follow-up he indicated pain and loss of function of his wrist due to a distal radio-ulnar dislocation with a high position of the ulna, causing loss of pronation and supination. This is also known as the Essex-Lopresti lesion. Operative treatment included reduction and fixation of the distal radio-ulnar joint after resection osteotomy of the distal ulnar shaft according to Sauvé and Kapandji.

'Blind' transfusion of blood products in exsanguinating trauma patients.

BACKGROUND: In trauma, as interventions are carried out to stop bleeding, ongoing resuscitation with blood products is of vital importance. As transfusion policy in exsanguinating patients cannot be based on laboratory tests, transfusion of blood products is performed empirically or 'blindly'. The aim of this study was to delineate 'blind' transfusion practice in the hectic clinical situation of exsanguination. METHODS: Seventeen trauma patients were selected who died due to uncontrolled bleeding despite haemostatic interventions within 24h after admission and who received more than 12 U of RBC. Transfusion data were compared with a theoretically optimal transfusion model with a fixed ratio between units of RBC, FFP, and platelets. The difference between the observed and expected amounts of blood products was calculated. RESULTS: The patients (82%) received insufficient amounts of FFP and platelets when compared to the calculated amounts. The total numbers of transfused FFP and platelets were on average 50% lower than the calculated amounts. Regression models showed an increase of FFP and platelets with increasing amounts of RBC but not in sufficient quantities. CONCLUSION: Exsanguinating trauma patients receiving massive transfusions are subject to 'blind' transfusion. This is associated with insufficient transfusion of both FFP and platelets, which may aggravate bleeding. A 'blind' transfusion strategy consisting of a validated guideline with a predefined ratio of the different blood products, timing of laboratory tests as well as a sound logistic protocol facilitating this procedure, involving the blood bank and treating physicians, is needed urgently.

Safety of computer-assisted surgery for cannulated hip screws.

Computer-assisted orthopaedic surgery has developed considerably during the past few years. Several manufacturers produce hardware and software for use in trauma surgery. Validation of these systems before clinical application is mandatory to be sure they work accurately and safely. The accuracy of surgical performance is highly correlated with the cut-out percentages of hip screws. In a standardized operative setting, three cannulated hip screws were inserted in each of 20 sawbones. The screws were positioned either by fluoroscopic navigation technique or by conventional operative technique depending on randomization. Our primary aim was to assess whether computer-navigated screw fixation is equally safe compared with conventional screw fixation using fluoroscopy. To determine safety, we investigated number of drilling attempts, screw position, and radiation time. Secondary to these safety parameters, we also compared the operating time between the two procedures to assess the efficiency of computer navigation. Statistical analysis showed no differences regarding accuracy of screw position. Computer-assisted surgery resulted in fewer drilling attempts and less radiation time, with a similar operation time. We believe the currently used navigation system is safe and accurate.

[Diagnostic image (230). A man with bilateral shoulder dislocation]. / Diagnose in beeld (230). Een man met bilaterale schouderluxatie.

A 28-year-old man suffered acute primary posterior dislocation of the left shoulder and anterior dislocation of the right one due to a motor accident.

The role of recombinant factor VIIa in the treatment of life-threatening haemorrhage in blunt trauma.

BACKGROUND: Recombinant factor VIIa (rFVIIa) is a novel haemostatic agent originally developed to treat bleeding in haemophiliacs. Several case reports suggest effectiveness of rFVIIa in the treatment of patients without pre-existing bleeding disorders. The aim of this study is to evaluate treatment with recombinant (rFVIIa) in blunt trauma patients with uncontrolled bleeding. PATIENTS AND METHODS: This study was designed as a retrospective case review. Consecutive patients with life-threatening uncontrolled bleeding due to blunt trauma who were treated with rFVIIa were selected. Data were obtained from medical records. RESULTS: A total of eight blunt trauma patients were treated with rFVIIa for uncontrolled bleeding. After treatment the need for transfusion of red blood cells (RBC) decreased significantly from 31.3 +/- 15.8 to 6.1 +/- 6.8 units (P = 0.003), fresh frozen plasma (FFP) from 13.3 +/- 6.6 to 5 +/- 6.3 units (P = 0.02), and platelets from 3.6 +/- 1.8 to 1.5 +/- 2.3 units (P = 0.01). Three patients died of non-bleeding complications. The other five fully recovered. CONCLUSION: Treatment with rFVIIa reduced or stopped bleeding in all patients. No adverse events were registered. Prospective studies are mandatory to elucidate the role of rFVIIa in blunt trauma.

[A 'blind' transfusion policy in patients with acute severe blood loss]. / 'Blind' transfusiebeleid bij patiënten met acuut ernstig bloedverlies.

Three patients presented with acute, excessive bleeding: a 54-year-old man following trauma to the pelvis, a 34-year-old woman with postpartum blood loss and a 62-year-old man with a duodenal ulcer. Treatment consisted of surgery, the administration of blood products and haemostatic agents, in varying strategies. The men recovered but the woman died as a result of cardiac rhythm disorders. It is unclear to what extent blood products should be used in patients with acute, excessive blood loss. Also, haemostatic agents have already found a place in the treatment of these patients, but it is unclear whether they should be administered early, as prophylaxis, or later when all other treatments have failed. While official registration of the haemostatic agent recombinant activated factor VII for this indication is pending, it is important that treatment with rFVIIa be embedded in a structured protocol to prevent overuse of blood products and administration of this medication to patients who do not need it. Controlled clinical trials for validation should be carried out prior to the implementation of such a protocol.

[Diagnostic and pharmaco-therapeutic options in acute severe blood loss]. / Diagnostische en farmacotherapeutische opties bij acuut ernstig bloedverlies.

In patients with excessive blood loss, coagulation is compromised by hypothermia, metabolic acidosis due to impaired tissue perfusion, loss of coagulation factors and platelets while their consumption is increased, and by massive infusion with plasma expanders. Currently available laboratory tests are insufficiently reliable and too time-consuming to enable the evaluation of the effect of pharmaco-therapeutic interventions during severe blood loss. Several haemostatic drugs appear to be effective in the treatment of blood loss after elective surgery, but have been insufficiently investigated in patients with severe bleeding. A rational transfusion policy entailing the use of sufficient amounts of plasma is necessary in the treatment of patients with severe bleeding.