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5,368 result(s) for "Fracture Fixation, Internal - methods"
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Fracture fixation in the operative management of hip fractures (FAITH): an international, multicentre, randomised controlled trial
Reoperation rates are high after surgery for hip fractures. We investigated the effect of a sliding hip screw versus cancellous screws on the risk of reoperation and other key outcomes. For this international, multicentre, allocation concealed randomised controlled trial, we enrolled patients aged 50 years or older with a low-energy hip fracture requiring fracture fixation from 81 clinical centres in eight countries. Patients were assigned by minimisation with a centralised computer system to receive a single large-diameter screw with a side-plate (sliding hip screw) or the present standard of care, multiple small-diameter cancellous screws. Surgeons and patients were not blinded but the data analyst, while doing the analyses, remained blinded to treatment groups. The primary outcome was hip reoperation within 24 months after initial surgery to promote fracture healing, relieve pain, treat infection, or improve function. Analyses followed the intention-to-treat principle. This study was registered with ClinicalTrials.gov, number NCT00761813. Between March 3, 2008, and March 31, 2014, we randomly assigned 1108 patients to receive a sliding hip screw (n=557) or cancellous screws (n=551). Reoperations within 24 months did not differ by type of surgical fixation in those included in the primary analysis: 107 (20%) of 542 patients in the sliding hip screw group versus 117 (22%) of 537 patients in the cancellous screws group (hazard ratio [HR] 0·83, 95% CI 0·63–1·09; p=0·18). Avascular necrosis was more common in the sliding hip screw group than in the cancellous screws group (50 patients [9%] vs 28 patients [5%]; HR 1·91, 1·06–3·44; p=0·0319). However, no significant difference was found between the number of medically related adverse events between groups (p=0·82; appendix); these events included pulmonary embolism (two patients [<1%] vs four [1%] patients; p=0·41) and sepsis (seven [1%] vs six [1%]; p=0·79). In terms of reoperation rates the sliding hip screw shows no advantage, but some groups of patients (smokers and those with displaced or base of neck fractures) might do better with a sliding hip screw than with cancellous screws. National Institutes of Health, Canadian Institutes of Health Research, Stichting NutsOhra, Netherlands Organisation for Health Research and Development, Physicians' Services Incorporated.
Accelerated surgery versus standard care in hip fracture (HIP ATTACK): an international, randomised, controlled trial
Observational studies have suggested that accelerated surgery is associated with improved outcomes in patients with a hip fracture. The HIP ATTACK trial assessed whether accelerated surgery could reduce mortality and major complications. HIP ATTACK was an international, randomised, controlled trial done at 69 hospitals in 17 countries. Patients with a hip fracture that required surgery and were aged 45 years or older were eligible. Research personnel randomly assigned patients (1:1) through a central computerised randomisation system using randomly varying block sizes to either accelerated surgery (goal of surgery within 6 h of diagnosis) or standard care. The coprimary outcomes were mortality and a composite of major complications (ie, mortality and non-fatal myocardial infarction, stroke, venous thromboembolism, sepsis, pneumonia, life-threatening bleeding, and major bleeding) at 90 days after randomisation. Patients, health-care providers, and study staff were aware of treatment assignment, but outcome adjudicators were masked to treatment allocation. Patients were analysed according to the intention-to-treat principle. This study is registered at ClinicalTrials.gov (NCT02027896). Between March 14, 2014, and May 24, 2019, 27 701 patients were screened, of whom 7780 were eligible. 2970 of these were enrolled and randomly assigned to receive accelerated surgery (n=1487) or standard care (n=1483). The median time from hip fracture diagnosis to surgery was 6 h (IQR 4–9) in the accelerated-surgery group and 24 h (10–42) in the standard-care group (p<0·0001). 140 (9%) patients assigned to accelerated surgery and 154 (10%) assigned to standard care died, with a hazard ratio (HR) of 0·91 (95% CI 0·72 to 1·14) and absolute risk reduction (ARR) of 1% (−1 to 3; p=0·40). Major complications occurred in 321 (22%) patients assigned to accelerated surgery and 331 (22%) assigned to standard care, with an HR of 0·97 (0·83 to 1·13) and an ARR of 1% (−2 to 4; p=0·71). Among patients with a hip fracture, accelerated surgery did not significantly lower the risk of mortality or a composite of major complications compared with standard care. Canadian Institutes of Health Research.
Surgery versus cast immobilisation for adults with a bicortical fracture of the scaphoid waist (SWIFFT): a pragmatic, multicentre, open-label, randomised superiority trial
Scaphoid fractures account for 90% of carpal fractures and occur predominantly in young men. The use of immediate surgical fixation to manage this type of fracture has increased, despite insufficient evidence of improved outcomes over non-surgical management. The SWIFFT trial compared the clinical effectiveness of surgical fixation with cast immobilisation and early fixation of fractures that fail to unite in adults with scaphoid waist fractures displaced by 2 mm or less. This pragmatic, parallel-group, multicentre, open-label, two-arm, randomised superiority trial included adults (aged 16 years or older) who presented to orthopaedic departments of 31 hospitals in England and Wales with a clear bicortical fracture of the scaphoid waist on radiographs. An independent remote randomisation service used a computer-generated allocation sequence with randomly varying block sizes to randomly assign participants (1:1) to receive either early surgical fixation (surgery group) or below-elbow cast immobilisation followed by immediate fixation if non-union of the fracture was confirmed (cast immobilisation group). Randomisation was stratified by whether or not there was displacement of either a step or a gap of 1–2 mm inclusive on any radiographic view. The primary outcome was the total patient-rated wrist evaluation (PRWE) score at 52 weeks after randomisation, and it was analysed on an available case intention-to-treat basis. This trial is registered with the ISRCTN registry, ISRCTN67901257, and is no longer recruiting, but long-term follow-up is ongoing. Between July 23, 2013, and July 26, 2016, 439 (42%) of 1047 assessed patients (mean age 33 years; 363 [83%] men) were randomly assigned to the surgery group (n=219) or to the cast immobilisation group (n=220). Of these, 408 (93%) participants were included in the primary analysis (203 participants in the surgery group and 205 participants in the cast immobilisation group). 16 participants in the surgery group and 15 participants in the cast immobilisation group were excluded because of either withdrawal, no response, or no follow-up data at 6, 12, 26, or 52 weeks. There was no significant difference in mean PRWE scores at 52 weeks between the surgery group (adjusted mean 11·9 [95% CI 9·2–14·5]) and the cast immobilisation group (14·0 [11·3 to 16·6]; adjusted mean difference −2·1 [95% CI −5·8 to 1·6], p=0·27). More participants in the surgery group (31 [14%] of 219 participants) had a potentially serious complication from surgery than in the cast immobilisation group (three [1%] of 220 participants), but fewer participants in the surgery group (five [2%]) had cast-related complications than in the cast immobilisation group (40 [18%]). The number of participants who had a medical complication was similar between the two groups (four [2%] in the surgery group and five [2%] in the cast immobilisation group). Adult patients with scaphoid waist fractures displaced by 2 mm or less should have initial cast immobilisation, and any suspected non-unions should be confirmed and immediately fixed with surgery. This treatment strategy will help to avoid the risks of surgery and mostly limit the use of surgery to fixing fractures that fail to unite. National Institute for Health Research Health Technology Assessment Programme.
Jumper’s fracture of the sacrum: a novel and reproducible way for successful reduction and fixation
PurposeSurgical treatment of jumper’s fractures is a highly demanding situation for the surgeon due to its rareness and frequent association with severe concomitant injuries. There is no current consensus regarding a standard treatment approach, thus reducing quality of care. Our objectives were to describe, apply and assess a novel surgical technic.MethodsThe presented research is an observational retrospective study of patients who underwent the described novel surgical intervention in a level 1 trauma center. We conducted analyses of the patient cohort using patient-related outcome measures at least 1 year after surgery, as well as investigating pain, quality of life and the clinical effectiveness of the procedure.ResultsA total of 24 patients (17 male and 7 female) with an average age 47 ± 16.3 years were included. ISS scores ranged from 9 to 66 with a mean ISS of 40 ± 15. Clinical scores exist of 15 out of 24 patients (62.5%). The mean VAS score was 53.7 ± 12.9. The mean EQ-5D index was 0.68 ± 0.22. Significant negative correlation existed between the ISS value and the EQ-5D index (r =  − 0.704; p < 0.005) and EQ-5D VAS (r =  − 0.809; p < 0.001). Anatomical reduction was achieved in all patients (n = 24). Radiological follow-up was performed in 58%.ConclusionWe present one of the largest studies with operatively treated jumper’s fractures of the sacrum. The technique is capable of reproducibly restoring the physiological anatomy of the patient and allows pain-adapted mobilization.
Operative versus non-operative treatment for closed, displaced, intra-articular fractures of the calcaneus: randomised controlled trial
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.
Effect of melatonin on incidence of delirium among patients with hip fracture: a multicentre, double-blind randomized controlled trial
Disturbance of the sleep–wake cycle is a characteristic of delirium. In addition, changes in melatonin rhythm influence the circadian rhythm and are associated with delirium. We compared the effect of melatonin and placebo on the incidence and duration of delirium. We performed this multicentre, double-blind, randomized controlled trial between November 2008 and May 2012 in 1 academic and 2 nonacademic hospitals. Patients aged 65 years or older who were scheduled for acute hip surgery were eligible for inclusion. Patients received melatonin 3 mg or placebo in the evening for 5 consecutive days, starting within 24 hours after admission. The primary outcome was incidence of delirium within 8 days of admission. We also monitored the duration of delirium. A total of 452 patients were randomly assigned to the 2 study groups. We subsequently excluded 74 patients for whom the primary end point could not be measured or who had delirium before the second day of the study. After these postrandomization exclusions, data for 378 patients were included in the main analysis. The overall mean age was 84 years, 238 (63.0%) of the patients lived at home before admission, and 210 (55.6%) had cognitive impairment. We observed no effect of melatonin on the incidence of delirium: 55/186 (29.6%) in the melatonin group v. 49/192 (25.5%) in the placebo group; difference 4.1 (95% confidence interval −0.05 to 13.1) percentage points. There were no between-group differences in mortality or in cognitive or functional outcomes at 3-month follow-up. In this older population with hip fracture, treatment with melatonin did not reduce the incidence of delirium. Trial registration: Netherlands Trial Registry, NTR1576: MAPLE (Melatonin Against PLacebo in Elderly patients) study; www.trialregister.nl/trialreg/admin/rctview.asp?TC=1576
Nonoperative treatment versus volar locking plating for distal radius fracture in patients aged 65 years or older (DRIFT trial): A randomized controlled trial
The optimal management of distal radius fractures (DRFs) in older patients remains debatable. A knowledge gap exists concerning how to manage fractures with early malalignment during nonoperative treatment. We conducted a prospective, multicenter, and randomized controlled trial to compare nonoperative treatment to operative treatment with volar locking plating (VLP) in the management of primarily malaligned DRFs and DRFs that exhibit early malalignment during nonoperative treatment. The DRIFT trial was conducted at five trauma centers in Finland, Sweden, and Denmark. Patients aged 65 years or older with a dorsally displaced AO-type A or C DRF were included in the trial. Patients with DRF who did not maintain alignment after closed reduction (CR) were randomized in 1:1 ratio to nonoperative treatment or VLP. Patients with acceptable alignment after CR visited the outpatient clinic 5-10 days after CR. If the alignment was lost, the patients were randomized in 1:1 ratio to either continue nonoperative treatment or to VLP. The primary outcome measure was Patient Rated Wrist Evaluation (PRWE) at 12 months. The primary analysis method for PRWE was a linear mixed model. In the linear mixed model, patient was a random factor and age and intra/extra articularity of the fracture were fixed. Participants and orthopedic investigators were not blinded. The statisticians and investigators responsible for the analysis remained blinded to the treatment groups during data analysis and the drawing of conclusions. Between March 15, 2018 and June 6, 2023, 291 patients aged 65 years or older (mean age 73 years (standard deviation (SD) 5.8), 258 women, 33 men) who had sustained a DRF were included in the trial. The 12-month follow-up was completed on June 11, 2024. One hundred twenty-four DRFs did not maintain acceptable fracture alignment after CR; 66 were randomized to nonoperative treatment and 58 to VLP. These patients are referred to as primarily malaligned DRFs. Eighty-six patients lost fracture alignment during the first 5-10 days of follow-up; 44 patients were randomized to continue nonoperative treatment, and 42 patients to VLP. These patients are referred to as early malaligned DRFs. In primarily malaligned DRFs, the estimated mean effect for PRWE at 12 months was -9.6 points (95% confidence interval (CI) [-17.4, -1.7]; p = 0.0178) in favor of VLP, which is smaller than the predefined minimal clinically important difference (MCID) of the PRWE (11 points). In early malaligned DRFs, the mean effect for PRWE at 12 months was -6.2 points (95% CI [-15.4, 3.0]; p = 0.1816). At 12-month follow-up, we found 25 treatment-related adverse events (AE) (10/66, 15% in primarily malaligned DRFs nonoperative; 5/58, 8.6% in primarily malaligned DRFs operative; 2/44, 4.5% in early malaligned DRFs nonoperative; 3/42, 7.1% in early malaligned DRFs operative; 5/63, 7.9% in well-aligned DRFs) and 11 other AE. The trial recruitment period was longer than expected due to the restrictions caused by the global COVID-19 pandemic. Due to the decreased inclusion rate, we had to cease the recruitment of patients with early malaligned DRF before reaching the predefined 57 patients per Arm, which was the main limitation of the trial. Operative treatment of primarily malaligned DRF with VLP may slightly improve wrist function at 12 months. The estimated mean difference between the groups was, however, smaller than the predefined MCID of the PRWE (11 points). In DRFs with early loss of alignment, operative treatment does not appear to provide benefit. Our results suggest that the choice of treatment modality should be made following primary fracture reduction because subsequent monitoring of fracture alignment does not offer any additional benefit in terms of expected wrist function. This questions the need for early radiographic follow-up during the nonoperative treatment. The trial was registered at ClinicalTrials.gov (Identifier: NCT02879656, registration date 08/17/2016).
Arthroscopic reduction and internal fixation (ARIF) versus open reduction internal fixation (ORIF) to elucidate the difference for tibial side PCL avulsion fixation: a randomized controlled trial (RCT)
Purpose To compare the clinical, radiological outcomes, economic and technical differences for ORIF by cancellous screw fixation versus ARIF by double-tunnel suture fixation for displaced tibial-side PCL avulsion fractures. Methods Forty patients with displaced tibial-sided PCL avulsions were operated upon after randomizing them into two groups (20 patients each in the open and arthroscopic group) and followed up prospectively. Assessment included duration of surgery, cost involved, pre- and post-operative functional scores, radiological assessment of union, and posterior laxity using stress radiography and complications. Results The mean follow-up period was 33 months (27–42) (open group) and 30 months (26–44) (arthroscopic group). The duration of surgery was significantly larger in the arthroscopic group (47.8 ± 17.9 min) as compared to the open group (33.4 ± 10.1 min). The costs involved were significantly higher in the arthroscopic group ( p − 0.01). At final follow-up, knee function in the form of IKDC (International Knee Documentation Committee) evaluation (89.9 ± 4.8-open and 89.3 ± 5.9-arthroscopic) and Lysholm scores (94.2 ± 4.1-open and 94.6 ± 4.1-arthroscopic) had improved significantly with the difference (n.s.) between the two groups. The mean posterior tibial displacement was 5.7 ± 1.8 mm in the open group and 6.3 ± 3.1 mm in the arthroscopic group which was (n.s.). There were two non-unions and one popliteal artery injury in the arthroscopic group. Conclusion Both ARIF and ORIF for PCL avulsion fractures yield good clinical and radiological outcomes. However, ORIF was better than ARIF in terms of cost, duration of surgery, and complications like non-union and iatrogenic vascular injury. Level of evidence II.
Helical plating yields better outcomes than intramedullary nailing or long straight lateral plating for humeral shaft fractures extending to the proximal humerus
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.