Objective To summarize the surgical experience and clinical results of the first 89 fractures of the proximal tibia treated with the Less Invasive Stabilization System (LISS; Synthes, Paoli, PA). Design Retrospective analysis of prospectively enrolled patients into a database. Setting Academic level I trauma center. Subjects/participants Eighty-seven consecutive patients with 89 proximal tibia fractures (AO/OTA type 41 and proximal type 42 fractures) treated by 2 surgeons. Seventy-five patients with 77 fractures were followed until union. The mean follow-up was 14 months (range: 3-35 months). There were 55 closed fractures and 22 open fractures. Intervention Surgical reduction and fixation of fractures, followed by rehabilitation. Main outcome measurements Perioperative and postoperative complications, postoperative alignment, loss of fixation, time to full weight bearing, radiographic union, and range of motion. Results Seventy of 77 fractures healed without major complications (91%). There were 2 early losses of proximal fixation, 2 nonunions, 2 deep delayed infections, and 1 deep peroneal nerve palsy. Other complications included a superficial wound infection and 3 seromas. Postoperative malalignment occurred in 7 patients with 6 degrees to 10 degrees of angular deformity (6 flexion/extension and 1 varus/valgus malalignments), and an eighth patient had a 15 degrees flexion deformity. In 4 patients, the hardware was removed at an average of 13 months because of irritation (5%). The mean time for allowance of full weight bearing was 12.6 weeks (range: 6-21 weeks), and the mean range of final knee motion was 1 degrees to 122 degrees . Conclusions The LISS provides stable fixation (97%), a high rate of union (97%), and a low (4%) rate of infection for proximal tibial fractures. The technique requires the successful use of new and unfamiliar surgical principles to effect an accurate reduction and acceptable rate of malalignment.

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Treatment of proximal tibia fractures using the less invasive stabilization system: surgical experience and early clinical results in 77 fractures

Information illustrating the benefits of fracture stabilization after multiple trauma has been gathering for almost a century. At the turn of the last century, the introduction of the Thomas splint clearly demonstrated the importance of skeletal stabilization in the management of these patients. The introduction of standardized surgical treatment for fractures in the early 1950s is considered today as the turning point in the care of the polytraumatized patient. With the knowledge acquired, the application of early operative fixation of fractures in severely injured patients in the 1980s has yielded to the concept of early total care of all fractures. Yet, in distinct patient subgroups with severe thoracic injuries and very high injury severity scores, this concept has been associated with adverse outcomes. Therefore, in a further era that began in the 1990s, a different approach has been favored for these subgroups. It recommends early (initial) temporary stabilization followed by secondary definitive osteosynthesis of major fractures in patients at high risk of developing systemic complications. In the last decade, attempts have been made to determine which patients benefit from early total care and which ones should undergo a secondary definitive approach. This manuscript provides a historical overview on the changing treatment of fractures and summarizes the evolution of "damage control orthopedic surgery."

The timing of fracture treatment in polytrauma patients: relevance of damage control orthopedic surgery.

Background: The care of the patient with the fractured femur entails a multiple surgical team approach. Healing of the fracture and expediency in the operating room are both important. We sought to determine the results of the treatment of fractures of the femoral shaft with interlocking femoral nails inserted with closed techniques, and to compare the outcomes of fractures nailed by using a fracture table with those stabilized with the leg draped free on a radiolucent table. Methods: Eight hundred eighty-two consecutive patients with fractures of the femoral shaft treated with a first-generation intramedullary nail at the authors' institution during the years 1986 to 1996 were identified. Five hundred fifty-one fractures in 515 patients met the inclusion criteria. Results: Treatment with an intramedullary nail led to a union rate of 98.9%. There were six infections, all occurring in closed fractures. Thirty-eight percent of the fractures had hardware removed, most commonly because of pain. One nail and 13 locking bolts broke. Four hundred eighteen fractures had adequate radiographs available to assess fracture alignment. No fracture healed with more than 10 degrees of angulation in either plane. Forty-four fractures healed with more than 5 degrees of angulation. A distal third fracture was found to be associated with an increased incidence of malalignment. There were no differences in outcomes between fractures stabilized with or without a fracture table. Conclusion: Reamed intramedullary nailing of femoral shaft fractures results in a low rate of nonunion, malunion, infection, and hardware failure. There is no difference in the outcomes of fractures treated with and without the use of a fracture table. This is particularly useful in the patient with multiple injuries for whom transfer to a fracture table may not be time effective.

Reamed intramedullary nailing of the femur : 551 cases

Objectives:
The timing of definitive fixation for major fractures in patients with multiple injuries is controversial. To address this gap, we randomized patients with blunt multiple injuries to either initial definitive stabilization of the femur shaft with an intramedullary nail or an external fixateur with later conversion to an intermedullary nail and documented the postoperative clinical condition.

Impact of the Method of Initial Stabilization for Femoral Shaft Fractures in Patients With Multiple Injuries at Risk for Complications (Borderline Patients)

Background: Damage control orthopedic surgery has recently been advocated for the management of femoral shaft fractures in severely injured patients because surgical procedures were found to represent a second-hit phenomenon regarding the operative burden. It has been attempted to determine the operative burden by means of proinflammatory cytokines. In this study in clinically stable patients with multiple injuries, the effects induced by different types of primary fracture stabilization on the systemic release of proinflammatory cytokines were evaluated. Methods: This was a prospective, randomized, multicenter intervention study. Inclusion criteria were long bone shaft fracture of the lower extremity; age 18 to 65 years; Injury Severity Score > 16 or more than three extremity injuries (Abbreviated Injury Scale [AIS] score of 2 or more) in association with another injury (AIS score of 2 or more); and thoracic AIS score < 4. After informed consent, randomization for the treatment of the femoral shaft fracture was performed at admission. Groups were as follows: group I°FN (primary, < 24 hours) intramedullary nailing, and group DCO (DCO, I°ex.fix.) damage control orthopedic surgery and external fixation. In DCO patients, measurements were also performed at the time of conversion to the intramedullary procedure (DCO II°FN). Parameters included clinical parameters and complications (acute respiratory distress syndrome, multiple organ failure, sepsis). From serially sampled central venous blood, the perioperative concentrations of interleukin IL-1, IL-6, and IL-8 were determined. Results: Thirty-five patients were included (I°FN, n = 17; DCO, n = 18). In I°FN-patients, a perioperative increase of IL-6 levels was measured (preoperatively, 55 ± 33 pg/dL; 24 hours postoperatively, +254 ± 55 pg/dL; p = 0.03), which was not found in subgroup DCO I°Ex.fix.; preoperatively, 71 ± 42 pg/dL; 24 hours postoperatively, 68 ± 34 pg/dL; not significant [NS] or in group DCO II°FN: preoperatively, 36 ± 21 pg/dL; 24 hours postoperatively, +39 ± 25 pg/dL; NS. Likewise, in I°FN patients, a perioperative increase of IL-8 levels was measured only at the 7-hour time point (preoperatively, 35 ± 29 pg/dL; 7 hours postoperatively, 95 ± 23 pg/dL; p < 0.05), which was not found in group DCO I°Ex.fix.: preoperatively, 43 ± 38 pg/dL; 24 hours postoperatively, 69 ± 39 pg/dL; NS or in group DCO II°FN: preoperatively, 25 ± 20 pg/dL; 24 hours postoperatively, 36 ± 29 pg/dL; NS. There were no differences in the complication rate in terms of acute respiratory distress syndrome, sepsis, or multiple organ failure. Conclusion: In this prospective, randomized, multicenter study, a sustained inflammatory response was measured after primary (<24 hours) intramedullary femoral instrumentation, but not after initial external fixation or after secondary conversion to an intramedullary implant. These findings may become clinically relevant in patients at high risk of developing complications. It confirms previous studies in that damage control orthopedic surgery appears to minimize the additional surgical impact induced by acute stabilization of the femur.

Impact of intramedullary instrumentation versus damage control for femoral fractures on immunoinflammatory parameters: prospective randomized analysis by the EPOFF Study Group.

Background: The optimal treatment of major fractures in patients with blunt multiple injuries continues to be discussed. The aim of this study is to investigate the clinical course of polytrauma patients treated at a Level I trauma center within the last two decades regarding the effect of changes in the management of their femoral shaft fracture. Methods: In a retrospective cohort study performed at a Level I trauma center, the patient injuries and clinical outcomes were studied. Adult blunt polytrauma patients were included if a femoral shaft fracture eligible for intramedullary stabilization was stabilized (including external fixation) primarily < 8 hours after primary admission. Patients were separated according to the management strategies for the femur fracture (I° intramedullary nailing [I°IMN]; I° external fixation [I°EF]; I° plate osteosynthesis [I°plate]) followed during a certain time period: (1) early total care (ETC) (January 1, 1981-December 31, 1989) and early (< 24 hours) definitive stabilization; (2) intermediate (INT) (January 1, 1990-December 31, 1992) change in the protocol; or (3) damage control orthopedic surgery (DCO) (January 1, 1993-December 31, 2000), early (< 24 hours) temporary stabilization, and secondary conversion to intramedullary nailing in patients at risk of organ failure. Results: The patient groups were comparable regarding age, gender distribution, and the mechanism of injury. Primary external fixation was performed significantly more frequent in the INT (23.9%) and DCO (35.6%) groups compared with the ETC group (16.6%) (p = 0.02 ETC vs. DCO). Plating of the femur was almost abolished in the 1990s (DCO, 6.8%; ETC, 23.4%). In the subgroups categorized to I°EF (ETC, 41.1 points; INT, 37.1 points; DCO, 39.1 points), the general injury severity was higher in comparison with the I°IMN group (ETC, 38.3%; INT, 36.1%; DCO, 35.8%). Thoracic or abdominal injuries accounted for significantly higher numbers of patients submitted to I°EF in the INT (13.6%, p = 0.03) and DCO (17.3%, p = 0.01) groups, compared with the ETC (8.1%) group. A higher incidence of reamed nailing was present in the ETC group compared with the other groups (ETC, 96.1%; INT, 73.7%; DCO, 13.5%). No significant differences in the incidence of local complications were found. The incidence of multiple organ failure decreased significantly from the ETC to the DCO period regardless of the type of treatment of the femoral fracture. Moreover, there was a significantly higher incidence of acute respiratory distress syndrome (ARDS) when I°IMN (15.1%) and I°EF (9.1%) in the DCO subgroup were compared. Conclusion: A significant reduction in the incidence of general systemic complications regardless of the type of femur fixation used was found when comparing the time periods of 1981 to 1989 (ETC), 1990 to 1992 (INT), and 1993 to 2000 (DCO). The change in treatment protocols to external fixation and from reamed to unreamed nailing was not associated with an increased rate of local complications (pin-track infections, delayed unions, nonunions). Among other causes for the improved general outcome during the most recent time period (DCO), an increase in the frequency of air rescue, a change from reamed to unreamed nailing, and an increased awareness toward thoracic and abdominal injuries may have played a role. Even during the DCO era, IMN was associated with a higher rate of ARDS than I°EF.

Changes in the management of femoral shaft fractures in polytrauma patients: from early total care to damage control orthopedic surgery.

major fractures in patients with blunt multiple injuries continues to be discussed. The aim of this study is to investigate the clinical course of poly- trauma patients treated at a Level I trauma cen- ter within the last two decades regarding the ef- fect of changes in the management of their femoral shaft fracture. Methods: In a retrospective cohort study performed at a Level I trauma center, the pa- tient's injuries and clinical outcomes were stud- ied. Adult blunt polytrauma patients were in- cluded if a femoral shaft fracture eligible for intramedullary stabilization was stabilized (in- cluding external fixation) primarily < 8 hours after primary admission. Patients were separated according to the management strategies for the Results: The patient groups were com- parable regarding age, gender distribution, and the mechanism of injury. Primary external fixa- tion was performed significantly more frequent in the INT (23.9%) and DCO (35.6%) groups com- pared with the ETC group (16.6%) (p 0.02 ETC vs. DCO). Plating of the femur was almost abolished in the 1990s (DCO, 6.8%; ETC, 23.4%). In the subgroups categorized to I°EF (ETC, 41.1 points; INT, 37.1 points; DCO, 39.1 points), the general injury severity was higher in comparison with the I°IMN group (ETC, 38.3%; INT, 36.1%; DCO, 35.8%). Thoracic or abdom- inal injuries accounted for significantly higher numbers of patients submitted to I°EF in the INT (13.6%, p 0.03) and DCO (17.3%, p 0.01) groups, compared with the ETC (8.1%) group. A higher incidence of reamed nailing was present in the ETC group compared with the other groups (ETC, 96.1%; INT, 73.7%; DCO, 13.5%). No significant differences in the incidence of local complications were found. The incidence of mul- tiple organ failure decreased significantly from the ETC to the DCO period regardless of the type of treatment of the femoral fracture. Moreover, there was a significantly higher incidence of acute respiratory distress syndrome (ARDS) when I°IMN (15.1%) and I°EF (9.1%) in the DCO subgroup were compared. Conclusion: A significant reduction in the incidence of general systemic complications regardless of the type of femur fixation used was found when comparing the time periods of 1981 to 1989 (ETC), 1990 to 1992 (INT), and 1993 to 2000 (DCO). The change in treatment protocols to external fixation and from reamed to unreamed nailing was not associated with an increased rate of local complications (pin-track infections, delayed unions, nonunions). Among other causes for the improved general outcome during the most recent time period (DCO), an increase in the frequency of air rescue, a change from reamed to unreamed nailing, and an in- creased awareness toward thoracic and abdom- inal injuries may have played a role. Even dur- ing the DCO era, IMN was associated with a higher rate of ARDS than I°EF. In view of a lower complication rate despite higher injury severity compared with the ETC period, the introduction of DCO appears to be an adequate alternative for patients at high risk of develop- ing posttraumatic systemic complications such as ARDS and multiple organ failure.

Changes in the Management of Femoral Shaft Fractures in Polytrauma Patients : From Early Total Care to Damage Control Orthopedic Surgery

Following the development of the Less Invasive Sabilization System for Distal Femur a similar system for proximal tibia fractures (LISS PLT) was designed. Anatomical studies were carried out to define the shape of the plate and the position and orientation of the screws. Standard mechanical tests were performed to ensure that the LISS PLT fixation provides similar fatigue resistance to that of conventional plates. Finally, cadaver tibia pairs were used to compare the biomechanical performance of the new device to that of bilateral plating. An unstable intra-articular proximal tibia fracture model was used. The medial condyle of the tibias were submitted to loading cycles with increasing load levels and the vertical subsidence of the medial condyle during the loading cycles was monitored. Comparable stability against secondary loss of reduction was observed for the LISS PLT and the bilateral plating constructs.

Rayeed Garapati

Papers

Changes in the management of femoral shaft fractures in polytrauma patients: from early total care to damage control orthopedic surgery.

Changes in the Management of Femoral Shaft Fractures in Polytrauma Patients : From Early Total Care to Damage Control Orthopedic Surgery

LISS PLT: design, mechanical and biomechanical characteristics.