Purpose: Failure to adequately recruit patients in orthopaedic trials has often led to early stopping and publication of research findings from smaller sample sizes than originally planned. The purpose of this study is to demonstrate the effect of sample size in a large, clinical trial by using SPRINT trial data to evaluate the results that would have been reported if the trial were stopped at various enrollments. Method: The SPRINT trial evaluated reamed vs. unreamed nailing in 1226 tibia fractures. We analyzed the re-operation rates after various increments in sample size and compared the early results that would have been reported at smaller enrollments with those seen in the final, adequately powered study. Results: In the final analysis of 1226 patients, there was a significant reduction in the risk of re-operation with
In order to define the operative indications, we compared the post-operative complications, time of consolidation, incidence of compartment syndrome, and fat embolism in centro medullary nails made from two different metals. This study includes approximately 234 centro medullary nails (TARGON System) used for treatment of diaphysal fractures of the leg or femur after a skiing injury. Steel nails were used before 1998 and titanium nails after 1998. The time of consolidation was the same for steel nails and titanium
Aims: Neutrophil (PMN) dysfunction is implicated in both acute respiratory distress syndrome (ARDS) and sepsis. We aimed to determine the PMN response following isolated long-bone/pelvic fracture by investigating temporal changes in PMN migration and surface receptor expression (CXCR1, PECAM- 1, &
CD18/ CD11b) following injury. Methods: Of the 20 patients consented to enter the study, 14 underwent
Introduction: Road side accidents resulting in polytrauma with an associated fracture of femur is a common pattern of injury in asian countries. We hypothesised that the use of unreamed nailing in the management of such fractures has better outcome than
Background. RHF nail is an important tool for simultaneous ankle and subtalar joint stabilisation +/− fusion. Straight and curved RHF nails are available to use, but both seem to endanger plantar structures, especially the lateral plantar artery and nerve and Baxter's nerve. There is a paucity of literature on the structures at risk with a straight RHF nail inserted along a line bisecting the heel pad and the second toe (after Stephenson et al). In this study, plantar structures ‘at risk’ were studied in relation to a straight nail inserted as above. Methods. Re-creating real-life conditions and strictly following the recommended surgical technique with regards to the incision and guide-wire placement, we inserted an Orthosolutions Oxbridge nail into the tibia across the ankle and subtalar joints in 6 cadaveric specimens. Tissue flaps were then raised to expose the heel plantar structures and studied their relation to the inserted nail. Results. The medial plantar artery and nerve were always more than 10mm away from the medial edge of the nail, while the Baxter nerve was a mean 14mm behind. The lateral plantar nerve was a mean 7mm medial to the nail, while the artery was a mean 2.3mm away with macroscopic injury in one specimen. The other structures ‘at risk’ were the plantar fascia and small foot muscles. Conclusion. Lateral plantar artery and nerve are the most vulnerable structures during straight RHF nailing. The risk to heel plantar structures could be mitigated by making incisions longer, blunt dissection down to bone, meticulous retraction of soft tissues and placement of the protection sleeve down to bone to prevent the entrapment of plantar structures during guide-wire placement,
Winner of ISFR Best Paper Award. Introduction: Surgeons agree on the benefits of intramedullary nailing of tibial shaft fractures. We assessed the impact of reamed versus unreamed intramedullary nailing on re-operation rates. Methods: The Study to Prospectively Evaluate Reamed Intamedullary Nails in Tibial Fractures (SPRINT) was a multi-center, randomized trial including 29 clinical sites. 1339 patients with tibial shaft fractures were randomized to either reamed or unreamed intramedullary nail insertion. Re-operations before 6 months were not permitted unless there was critical bone loss. The primary outcome was re-operation to promote healing, treat infection, or preserve the limb. We planned a priori to conduct a subgroup analysis of outcomes in patients with open and closed fractures. Results: Of 1339 enrolled patients, 1226 patients were followed to 1 year. Across treatment groups, patients did not differ in age, gender, and fracture types. The overall event rate was 17.8% (13.7% closed, 27%, open fractures). In 826 patients with closed fractures, patients with a
Purpose: Accurate prediction of re-operation following tibial nailing may facilitate optimal patient care. We recently completed the SPRINT trial, a large, multi-centre trial of reamed versus non-reamed intramedullary nails in 1226 patients with tibial shaft fractures. Using the SPRINT data, we conducted an investigation of baseline and surgical patient characteristics to determine if they are associated with increased risk of re-operation within one year. Method: Using multivariable logistic regression analysis, we investigated 15 characteristics for association with increased risk of re-operations. Because the primary SPRINT analysis found that
Aims: To present the experience of our department in the treatment of the closed shaft tibial fractures using the unreamed nail of Orthoþx. Material- Method: Between 1991–2001 we treated 180 closed fractures. There were162 men and 18 women. The preferred method of stabilization is unreamed nailing. Results: The average follow-up was 38 months. 165 of the fractures that were treated with uiin, healed in the proper time (3–6 months). The rest of them did not have callus signs and we revised the
Purpose: Surgeons agree on the benefits of intramedullary nailing of tibial shaft fractures. The SPRINT primary objective aimed to assess the impact of reamed versus unreamed intramedullary nailing on rates of re-operation in patients with tibial shaft fractures. Method: The Study to Prospectively Evaluate Reamed Intramedullary Nails in Tibial Fractures (SPRINT) was a multi-centre, randomized trial including 29 clinical sites. SPRINT enrolled 1319 patients with open or closed tibial shaft fractures. Patients, outcome assessors, and data analysts were blinded to treatment allocation. Peri-operative care was standardized, and re-operations before 6 months were not permitted unless there was critical bone loss. Patients received a statically locked intramedullary nail with either reamed or unreamed insertion. The primary outcome was re-operation to promote healing, treat infection, or preserve the limb. We planned a priori to conduct a subgroup analysis of outcomes in patients with open and closed fractures. Our sample size calculations required 1200 patients followed for 1 year. Results: Of 1319 enrolled patients, 1226 patients were followed to 1 year. Across treatment groups, patients did not differ in age, gender and closed and open fracture types (I-IIIB). The overall event rate was 17.8% (13.7% closed, 26.5%, open fractures). A significant subgroup interaction effect in patients with open versus closed fractures (p=0.01) mandated a separate analysis for each subgroup. In 826 patients with closed fractures, patients with a
Aim. Post traumatic distal tibia osteomyelitis (DTOM) with an upper ankle joint involvement is a serious complication after primary osteosynthesis and can be a nightmare for the patient and the surgeon as well. Our aim was to identify mayor complications during treatment and to find the way to prevent or treat them. Method. It is a retrospective analysis of eight patients with DTOM and an upper ankle joint involvement treated in our institution from 2012 to 2018. The average size of a bone defect after a debridement was 9 centimeters (4–15). Patients were treated in two stages. First stage was segmental bone resection, external fixation and soft tissue envelope reconstruction if necessary. At second stage a distraction frame was applied and proximal corticotomy performed. In all but one case a circular frame was used. Results. We have had one major intra-operative complication, an injury of arteria tibialis posterior during the corticotomy procedure. Except in one patient we did not observe major problems with pin-track infections. Despite bone-grafting in all patients, we observed three nonunions of docking site. We treated them by external fixator in two and retrograde intramedullar nail in one case. In two patient the distraction callus was weak. We had to bone graft and secure the callus with a plate in one and use a retrograde
Background. In a systematic review of 1125 distal tibia fractures treated with an intramedullary nail, the reported incidence of malalignment was 14%. The purpose of our study is to assess whether the addition of blocking screws during intramedullary nailing of a distal tibia fracture improved radiological outcomes. As a secondary outcome, the time to radiographic union was compared to see if a more rigid bone-implant construct had an effect on healing. Methods. We searched computerised records at a UK level 1 major trauma centre. The joint alignment was measured on the immediate post-operative radiograph and compared to the most recent radiograph. We used a difference of 2 degrees to indicate a progressive deformity and a RUST score greater or equal to 10, to indicate radiographic fracture union. Results. Twenty-seven patients were included. Nineteen patients had no blocking screw and 8 patients had a blocking screw. Five patients had a difference in their coronal plane alignment of 2 degrees or more (3/5 had no blocking screw). The results were analysed and found to be not statistically significant (p=0.88). The addition of a blocking screw has also been shown not to have an effect on the time to union. Conclusion. We have changed our surgical practice. We use a 2.5mm blocking wire to aid in fracture reduction prior to
Purpose. There is no clear definition of a critical sized defect of the tibia. We defined it as a fracture gap at least one centimeter in length and involving over 50% of the cortical diameter. We explored if the presence of a critical-sized defect predicted reoperation, and which other factors predict reoperation in patients with the critical defect. The patient based outcomes of these patients were compared to patients without a critical defect. Method. Patients enrolled in the SPRINT trial with a critical sized defect were evaluated for secondary interventions to gain union. Other factors predicting the need for reoperation were studied. We also compared the patients with critical sized defects to the larger cohort of patients without a defect with respect to demographics, injury mechanism, fracture characteristics, and patient-based outcome. Results. Tibial diaphyseal defects of greater than or equal to one centimeter and >50% cortical circumference healed without additional surgery in 47% of cases. Fewer reoperations were required in patients treated with a
Unreamed, small diameter nails with interlocking capability have become the preferred treatment for most unstable tibial fractures, but have been shown to have a high rate of hardware breakage and frequently require secondary procedures to obtain union. Reamed nailing may offer advantages for fracture healing due to the use of larger implants and increased stability, but may cause higher rates of infection and compartment syndrome. In order to determine if there is a difference in healing or complications in open and closed tibial fractures treated with reamed or unreamed intramedullary nailing, we performed a prospective, surgeon-randomized comparative study. Ninety-four closed and open, unstable tibial shaft fractures (excluding Gustilo Types IIIB and C) treated with intramedullary nailing were studied. Our findings support the use of
Purpose. The aim of this study was to investigate whether growth factors essential for fracture healing are released in the immediate aftermath following fracture and whether reaming of IM cavity causes increased liberation of these autocoids. Methods. Consecutive adult patients with femoral shaft fractures forming two groups (a group who received unreamed nail (n=10) and a second group who received
Aims: The purpose of our study is to present pitfalls and complications of intramedullary nailing in the treatment of femoral fractures and to examine their effect in bone healing. Methods: 180 patiens, suffering a femoral fracture, underwent primary intramedullary nailing and were followed up from 1996 to 2000 in our clinic (mean 16 months). 163 were men and 17 were women with a mean age 28 years. Four types of implants were used including AO, R-T, GK
Aims: Outcome of the distal tibial fractures treated with interlocking nail. Method: We reviewed 108 patients with distal tibial fractures which were treated in our clinic between 1990 using interlocking intramedullary nailing. 94 patients (63 men and 31 women) were found in the recent follow up. AO fracture classiþcation system was used Seventy-eight patients had concomitant fractures of the lateral malleolar and 4 had medial malleolar fractures. Eight (8,5%) of the fractures were open grade I. All fractures were managed with closed
Purpose: The aim of this study was to investigate whether growth factors essential for fracture healing are released in the immediate aftermath following fracture and whether reaming of IM cavity causes increased liberation of these autocoids. Methods: Consecutive adult patients with femoral shaft fractures forming two groups (a group who received unreamed nail (n=10) and a second group who received
Objectives The objective of this study was to investigate accelerated bone healing in patients with femoral shaft fractures. Methods Data on patients with diaphyseal femoral fractures admitted to our trauma unit between 1997 and 2002 was collected and analysed. Patients were categorised into three groups by the presence or absence of head injury, and the reamed or undreamed nailing technique used. Severity of head injury was quantified using abbreviated injury score (AIS) and Glasgow Coma Scale (GCS). Time to bony union was assessed from serial of x-rays and clinical examination. Patients were followed to discharge in outpatient clinics until bony union. Results Group 1 ( Patients with head injury). In total 17 patients (14 male, 3 female). mean age 29.4(14–53). open fractures 2. Mean AIS 3.2 (2–5). Fracture treatment was
Aims: To investigate the effect of tibial reamed intramedullary nailing in treating tibial shaft aseptic nonunion. Method: Between 1990 to 2002, the intramedullary nailing was used in100 patients with aseptic tibial nonunion. Seventy-þve were men and 25 women with a mean age of 31 years (ranging from 18 to 76 years). Thirty-eight (38%) of the fractures were initially open (A:9, B:12, C:15) according to Gustilo-Anderson classiþcation. Sixty-seven (67%) cases were initially treated with external þxation, 13 (13%) with plate and screws, 6 (6%) with I.N., and 14 (14%)with plaster of Paris. The time that elapsed from injury to intramedullary nailing ranged from 6 months to 7 years (mean 15,6 months). Fibular osteotomy was performed in 76 cases through a separate incision. In 6 cases bone grafts from the iliac crest were used. Results: During a follow-up period of one to seven years (mean: 2 years), all of the cases achieved consolidation an average of 6 months after nailing. In 4 cases a late infection was observed which settled after nail removal. One patient developed impending compartment syndrome which was detected on the þrst post-operative day and was treated with a fasciotomy. Transient peroneal nerve palsy occurred in one patient and this recovered in 3 months. In nine patients a clinically acceptable deformity was noticed. Conclusions: Because of its high union rate and low complication rate, we believe that the
Aim: The aim of this study was to compare the treatment results of distal tibia shaft fractures treated with intramedullary nails with two different distal lockings and medial locking plates. Patients and Method: Sixty-four patients with distal tibia fractures (4 to 11 cm proximal to the plafond) were operated with either unreamed intramedullary nails with medio-lateral distal locking (group A) or unreamed intra-medullary nails with both medio-lateral and antero-posterior lockings (group B), or medial locking plates (group C). There were 22 patients in group A, 22 patients in group B and 20 patients in group C. Mean age was 48.53±17.07 years. Mean follow-up was 26.68±7.02 months. At latest follow-up groups were compared for union time, malunion (defined as more than 5 degrees of angulation in any planes and/or any rotation and/or more than 5 milimeters of shortening), and delayed (lack of healing within 3 months) or nonunion (lack of healing within 6 months). Uninon was defined as healing of at least three of four cortices on AP and lateral radiographs. Results: Mean union time was 17.45±4.22 weeks in group A, 16.71±4.90 weeks in group B and 15.73±3.26 weeks in group C. There was no significant difference between groups regarding union time. (p>
0.05) Malunion as defined was dedected in 4 patients in group A, in 4 patients in group B and in 1 patient in group C. There was no significant difference between groups regarding malunion rates. (p>
0.05). Delayed or non union was dedected in 6 patients in group A, in 5 patients in group B and in 1 patient in group C. There was no significant difference between groups regarding delayed or non-union. (p>
0.05). Two nonunions in group A and one nonunion in group B had to be treated with exchance