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Objective To investigate whether surgery by open reduction and internal fixation provides benefit compared with non-operative treatment for displaced, intra-articular calcaneal fractures.Design Pragmatic, multicentre, two arm, parallel group, assessor blinded randomised controlled trial (UK Heel Fracture Trial).Setting 22 tertiary referral hospitals, United Kingdom.Participants 151 patients with acute displaced intra-articular calcaneal fractures randomly allocated to operative (n=73) or non-operative (n=78) treatment.Main outcome measures The primary outcome measure was patient reported Kerr-Atkins score for pain and function (scale 0-100, 100 being the best possible score) at two years after injury. Secondary outcomes were complications; hindfoot pain and function (American Orthopaedic Foot and Ankle Society score); general health (SF-36); quality of life (EQ-5D); clinical examination; walking speed; and gait symmetry. Analysis was by intention to treat.Results 95% follow-up was achieved for the primary outcome (69 in operative group and 74 in non-operative group), and a complete set of secondary outcomes were available for 75% of participants. There was no significant difference in the primary outcome (mean Kerr-Atkins score 69.8 in operative group v 65.7 in non-operative group; adjusted 95% confidence interval of difference −7.1 to 7.0) or in any of the secondary outcomes between treatment groups. Complications and reoperations were more common in those who received operative care (estimated odds ratio 7.5, 95% confidence interval 2.0 to 41.8).Conclusions Operative treatment compared with non-operative care showed no symptomatic or functional advantage after two years in patients with typical displaced intra-articular fractures of the calcaneus, and the risk of complications was higher after surgery. Based on these findings, operative treatment by open reduction and internal fixation is not recommended for these fractures.Trial registration Current Controlled Trials ISRCTN37188541.

Background Studies comparing plate with intramedullary nail fixation of displaced midshaft clavicle fractures show faster recovery in the plate group and implant-related complications in both groups after short-term followup (6 or 12 months). Knowledge of disability, complications, and removal rates beyond the first postoperative year will help surgeons in making a decision regarding optimal implant choice. However, comparative studies with followup beyond the first year or two are scarce. Questions/purposes We asked: (1) Does plate fixation or intramedullary nail fixation for displaced midshaft clavicle fractures result in less disability? (2) Which type of fixation, plate or intramedullary, is more frequently associated with implant-related irritation and implant removal? (3) Is plate or intramedullary fixation associated with postoperative complications beyond the first postoperative year? Methods Between January 2011 and August 2012, patients with displaced midshaft clavicle fractures were enrolled and randomized to plate or intramedullary nail fixation. A total of 58 patients with plate and 62 patients with intramedullary nails initially were enrolled. Minimum followup was 30 months (mean, 39 months; range, 30–51 months). Two patients (3%) with plate fixation and two patients (3%) with intramedullary nails were lost to followup. The QuickDASH was obtained at final followup and compared between patients who had plate fixation and those who had intramedullary nail fixation. Postoperative complications measured include infection, implant-related irritation, implant failure, nonunion, and refracture after implant removal. Indications for implant removal included implant-related irritation, implant failure, nonunion, patient’s wish, or surgeon’s preference. Results Between patients with plate versus intramedullary nail fixation, there were no differences in QuickDASH scores (plate, 1.8 ± 3.6; intramedullary nail, 1.8 ± 7.2; mean difference, −0.7; 95% CI, −2.2 to 2.04; p = 0.95). The proportion of patients having implant-related irritation was not different (39 of 56 [70%] versus 41 of 62 [66%]; relative risk, 1.05; 95% CI, 0.82–1.35; p = 0.683). Intramedullary fixation was associated with a higher likelihood of implant removal (51 of 62 [82%] versus 28 of 56 [50%]; relative risk, 1.65; 95% CI, 1.24–2.19; p < 0.001). Among the removed implants more plates than intramedullary nails were removed after the 1-year followup (12 of 28 [43%] versus six of 51 [12%]; p = 0.002). There were no infections, implant breakage, nonunions, or refractures between the 1-year and final followup in either group. Conclusions After a mean followup of 39 months, disability scores were excellent. Major complications did not occur after the 1-year followup. A frequent and bothersome problem after both surgical treatments is implant-related irritation, resulting in high rates of implant removal, after 1 year. Future research could focus on analyzing risk factors for implant irritation or removal. Level of Evidence Level II, therapeutic study.

Background This study was performed to compare the operative clinical outcomes of helical plating, intramedullary nailing (IMN), and long straight lateral plating in the treatment of humeral shaft fractures extending into the proximal humerus, as well as to identify the optimal fixation strategy for managing such injuries. Methods In total, 81 patients with humeral shaft fractures extending into the proximal humerus were divided into three groups based on treatment strategy: helical plating (Group A, n  = 16), IMN (Group B, n  = 12), and long straight lateral plating (Group C, n  = 53). Preoperative demographic data and imaging were collected from the medical records. Operative time, blood transfusion, bone reduction quality, bone healing rate, and incidence of complications were recorded. Clinical evaluation included the Constant–Murley score for shoulder function, the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire for upper limb function, the visual analogue scale (VAS) for pain, and assessments of shoulder stiffness or instability and patient satisfaction. Results Compared with Groups A and C, patients in Group B had a longer operative time and lower blood transfusion requirements. More than 80% of patients in each group achieved bone reduction quality rated as “better than good.” There were no significant differences among the three groups in operative time, blood transfusion, or shaft angulation. Bone healing rates were 100%, 91.7%, and 94.3% in Groups A, B, and C, respectively. Mean shoulder flexion was 155.0°, 130.0°, and 150.0°, respectively. Functional outcomes, including the Constant–Murley score, DASH score, VAS score, and patient satisfaction, were significantly better in Group A than in Groups B and C. No complications occurred in Group A. One patient in Group B developed nonunion. In Group C, complications were observed in five patients (9.4%). Conclusion In the treatment of humeral shaft fractures extending into the proximal humerus, helical plating was associated with a higher bone union rate, better functional outcomes, and a lower postoperative complication rate compared with IMN or long straight lateral locking plates. Outcomes after nailing and long straight lateral plating were similar.

Purpose The primary goal of this randomised controlled trial was to investigate whether there are differences in the outcome between the Gamma3 nail and a sliding hip screw (SHS) regarding quality of life 1 year after surgery. Methods In a controlled randomised trial, we compared the Gamma3 nail (Stryker) and a SHS (Omega, Stryker) in the treatment of 193 patients with pertrochanteric fractures. The follow-up period was 12 months. The outcomes included the surgical duration, health-related quality of life measured with the EQ-5D Index and a Visual Analogue Scale (VAS), the living situation and use of walking aid before trauma and 52 weeks after surgery; the Parker Mobility Score; the Harris Hip Score; and the revision, complication and mortality rates. Results The Gamma3 group had a significantly shorter surgical duration than the SHS group ( p  < 0.0001). Implant-related complications were significantly lower in the Gamma3 group ( p  > 0.05). The revision rate was significantly lower in the Gamma3 group based on intention-to-treat (p = 0.0336) as well as as-treated (p = 0.0302) analyses. Otherwise, we did not find significant difference between the two groups regarding the EQ-5D Index and VAS scores, the Parker Mobility Score, the Harris Hip Score, the mortality rate, the use of walking aids and the living situation. Conclusion There were no detectable differences between the groups in terms of quality of life and clinical scores 12 months after surgery. The surgical duration and revision rate were superior for the Gamma3 group.

Complications affect treatment outcomes and quality of life in addition to increasing treatment costs. To evaluate complication rates after the treatment of a distal radius fracture, to determine whether the rate or complication type is associated with treatment method, and to determine predictors of complications. The multicenter Wrist and Radius Injury Surgical Trial (WRIST), a randomized clinical trial, enrolled participants from April 10, 2012, to December 31, 2016. The study included 304 adults 60 years or older with isolated unstable distal radius fractures; 187 were randomized and 117 opted for casting. The study was conducted at 24 health systems in the United States, Canada, and Singapore. Data for this secondary analysis were collected from April 24, 2012, to February 28, 2018. Participants opting for surgery were randomized to receive the volar locking plate system (n = 65), percutaneous pinning (n = 58), or bridging external fixation with or without supplemental pinning (n = 64). Patients who chose not to have surgery (n = 117) were not randomized and were enrolled for casting. Complication rate. The WRIST enrolled a total of 304 participants, of whom 8 casting group participants were later found to be ineligible and were excluded from the analysis, leaving 296 participants. Randomized participants' mean (SD) age was 68 (7.2) years, 163 (87%) were female, and 165 (88%) were white. Casting participants' mean (SD) age was 75.6 (9.6) years, 93 (84%) were female, and 85 (85%) were white. The most common type of complications varied by treatment. Twelve of 65 participants (18.5%) in the internal fixation group reported a median nerve compression, while 16 of 26 participants (25.8%) who received external fixation and 13 of 56 participants (23.2%) who received pinning sustained pin site infections. Compared with the internal fixation group, complication rate for any severity complication was higher in participants who initially received casting (adjusted rate ratio, 1.88; 95% CI, 1.22-2.88), whereas the rate for moderate complications was higher in the external fixation group (adjusted rate ratio, 2.52; 95% CI, 1.25-5.09). The distal radius fracture treatment decision-making process for older patients should incorporate a complication profile for each treatment type. For example, external fixation and pinning could be used for patients after apprising them of pin site infection risk. Internal fixation can be done in patients with high functional demands who are willing to receive surgery. Internal fixation use should be substantiated owing to the time and cost involved. ClinicalTrials.gov Identifier: NCT01589692.

Background Lateral compression type1 (LC-1) fragility fractures are a common, painful injury in older adults resulting in reduced mobility. The incidence of these fractures is increasing with the growing older adult population. The current standard of care is non-surgical management; however, patients with this injury are at risk of long-term immobility and related complications. INFIX is a pelvic fixation device used in younger patients with high-energy fractures. The device is fitted via a percutaneous technique with no external pin sites and has good purchase even in osteoporotic bone. It therefore has the potential to be well tolerated in patients with LC-1 fragility fractures. INFIX could improve patients’ ability to mobilise and reduce the risk of immobility-related complications. However, there is a risk of complications related to surgery, and robust evidence is required on patient outcomes. This study will investigate the clinical and cost-effectiveness of surgical fixation with INFIX compared to non-surgical management of LC-1 fragility fractures in older adults. Methods A multi-centre randomised controlled trial of 600 patients allocated 1:1 to non-surgical management or INFIX surgery. The study will have a 12-month internal pilot to assess recruitment and trial feasibility. The primary outcome will be the patient quality of life over 6 months, measured by the patient-reported EQ-5D-5L. The secondary outcomes will include physical function, mental health, pain, delirium, imaging assessment, resource use, and complications. Discussion The L1FE study aims to compare the clinical and cost-effectiveness of surgical and non-surgical management of people aged 60 years and older with LC-1 fragility fractures. The trial is sufficiently powered and rigorously designed to inform future clinical and patient decision-making and allocation of NHS resources. Trial registration International Standard Randomised Controlled Trial Number Registry ISRCTN16478561. Registered on 8 April 2019

This study compared the results of external fixation combined with limited open reduction and internal fixation (EF + LORIF), minimally invasive percutaneous plate osteosynthesis (MIPPO), and intramedullary nailing (IMN) for distal tibia fractures. A total of 84 patients with distal tibia shaft fractures were randomized to operative stabilization using EF + LORIF (28 cases), MIPPO (28 cases), or IMN (28 cases). The 3 groups were comparable with respect to patient demographics. Data were collected on operative time and radiation time, union time, complications, time of recovery to work, secondary operations, and measured joint function using the American Orthopaedic Foot and Ankle Society (AOFAS) score. There was no significant difference in time to union, incidence of union status, time of recovery to work, and AOFAS scores among the 3 groups ( P >.05). Mean operative time and radiation time in the MIPPO group were longer than those in the IMN or EF + LORIF groups ( P <.05). Wound complications after MIPPO were more common compared with IMN or EF + LORIF ( P <.05). Anterior knee pain occurred frequently after IMN (32.1%), and irritation symptoms were encountered more frequently after MIPPO (46.4%). Although EF + LORIF was associated with fewer secondary procedures vs MIPPO or IMN, it was related with more pin-tract infections (14.3%). Findings indicated that EF + LORIF, MIPPO, and IMN all achieved similar good functional results. However, EF + LORIF had some advantages over MIPPO and IMN in reducing operative and radiation times, postoperative complications, and reoperation rate. [ Orthopedics. 2016; 39(4):e627–e633.]

Purpose Operative treatment for middle-third clavicle fractures has been increasing as recent data has demonstrated growing patient dissatisfaction and functional deficits after non-operative management. A controlled biomechanical comparison of the characteristics of locked intramedullary (IM) fixation versus superior pre-contoured plating for fracture repair and hardware removal is warranted. Therefore, the purpose of the present study was to investigate potential differences between these devices in a biomechanical model. Methods Thirty fourth-generation composite clavicles were randomized to one of five groups with 6 specimens each and tested in a random order. The groups tested were intact, repair with plate, repair with IM device, plate removal, and IM device removal. The lateral end of the clavicles was loaded to failure at a rate of 60 mm/min in a cantilever bending setup. Failure mechanism, energy (J), and torque (Nm) at the site of failure were recorded. Results Failure torque of the intact clavicle (mean ± standard deviation) was 36.5 ± 7.3 Nm. Failure torques of the IM repair (21.5 ± 9.0 Nm) and plate repair (18.2 ± 1.6 Nm) were not significantly different (n.s.) but were significantly less than the intact group ( P  < 0.05). Failure torque following IM device removal (30.2 ± 6.5 Nm) was significantly greater than plate removal (12.9 ± 2.0 Nm) ( P  < 0.05). No significant differences were observed between the intact and IM device removal groups (n.s.). Conclusion The results of the current study demonstrate that IM and plate devices provide similar repair strength for middle-third clavicle fractures. However, testing of the hardware removal groups found the IM device removal group to be significantly stronger than the plate removal group.

Although increasingly used, the benefit of surgical treatment of displaced 2-part proximal humerus fractures has not been proven. This trial evaluates the clinical effectiveness of surgery with locking plate compared with non-operative treatment for these fractures. The NITEP group conducted a superiority, assessor-blinded, multicenter randomized trial in 6 hospitals in Finland, Estonia, Sweden, and Denmark. Eighty-eight patients aged 60 years or older with displaced (more than 1 cm or 45 degrees) 2-part surgical or anatomical neck proximal humerus fracture were randomly assigned in a 1:1 ratio to undergo either operative treatment with a locking plate or non-operative treatment. The mean age of patients was 72 years in the non-operative group and 73 years in the operative group, with a female sex distribution of 95% and 87%, respectively. Patients were recruited between February 2011 and April 2016. The primary outcome measure was Disabilities of Arm, Shoulder, and Hand (DASH) score at 2-year follow-up. Secondary outcomes included Constant-Murley score, the visual analogue scale for pain, the quality of life questionnaire 15D, EuroQol Group's 5-dimension self-reported questionnaire EQ-5D, the Oxford Shoulder Score, and complications. The mean DASH score (0 best, 100 worst) at 2 years was 18.5 points for the operative treatment group and 17.4 points for the non-operative group (mean difference 1.1 [95% CI -7.8 to 9.4], p = 0.81). At 2 years, there were no statistically or clinically significant between-group differences in any of the outcome measures. All 3 complications resulting in secondary surgery occurred in the operative group. The lack of blinding in patient-reported outcome assessment is a limitation of the study. Our assessor physiotherapists were, however, blinded. This trial found no significant difference in clinical outcomes at 2 years between surgery and non-operative treatment in patients 60 years of age or older with displaced 2-part fractures of the proximal humerus. These results suggest that the current practice of performing surgery on the majority of displaced proximal 2-part fractures of the humerus in older adults may not be beneficial. ClinicalTrials.gov NCT01246167.