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814 result(s) for "Open Fracture Reduction"
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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.
Open versus minimally invasive percutaneous surgery for surgical treatment of thoracolumbar spine fractures- a multicenter randomized controlled trial: study protocol
Background Thoracolumbar fractures are most frequent along the spine, and surgical treatment is indicated for unstable fractures. Percutaneous minimally invasive surgery was introduced to reduce the pain associated with the open posterior approach and reduce the morbidity of the procedure by avoiding damage and dissection of the paravertebral muscles. The goal of this study is to compare the surgical treatment of fractures of the thoracolumbar spine treated by the conventional open approach and the percutaneous minimally invasive approach using similar types of pedicle spine fixation systems. Methods/designs This study is designed as a multi-center, randomized controlled trial of patients aged 18–65 years who are scheduled to undergo surgical posterior fixation. Treatment by the conventional open approach or percutaneous minimally invasive approach will be randomly assigned. The primary outcome measure is postoperative pain, which will be measured using the visual analogue scale (VAS). The secondary outcome parameters are intraoperative bleeding, postoperative drainage, surgery time, length of hospital stay, SF-36, EQ-5D-5 l, HADS, pain medication, deambulation after surgery, intraoperative fluoroscopy time, vertebral segment kyphosis, fracture vertebral body height, compression of the vertebral canal, accuracy of the pedicle screws, and breakage or release of the implants. Patient will be followed up for 1, 2, 3, 6, 12 and 24 months postoperatively and evaluated according to the outcomes using clinical and radiological examinations, plain radiographs and computed tomografy (CT). Discussion Surgical treatment of thoracolumbar fractures by the open or percutaneous minimally invasive approach will be compared in a multicenter randomized study using similar types of fixation systems, and the results will be evaluated according to clinical and radiological parameters at 1, 2, 3, 6, 12 and 24 months of follow-up. Trial registration ClinicalTrial.gov approval number: 1.933.631, code: NCT03316703 in may 2017.
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.
Open reduction internal fixation vs non-operative management in proximal humerus fractures: a prospective, randomized controlled trial protocol
Background Proximal humerus fractures are the third most common fracture in the elderly population and are expected to increase due to the aging population. Surgical fixation with locking plate technology has increased over the last decade despite a lack of proven superiority in the literature. Three previous randomized controlled trials have not shown a difference in patient-centered outcomes when comparing non-operative treatment with open reduction and internal fixation. Low patient enrollment and other methodological concerns however limit the generalizability of these conclusions and as a result, management of these fractures remains a controversy. By comparing the functional outcomes of locked plate surgical fixation versus non-operative treatment of displaced three and four-part proximal humerus fractures in the elderly population with a large scale, prospective, multi-centered randomized controlled trial, the optimal management strategy for this common injury may be determined. Methods We will conduct a prospective, single blind randomized controlled parallel arm trial to compare non-operative management of proximal humerus fractures with open reduction and internal fixation using locked plating technology. One-hundred and sixty patients > age 60 with acute 3- or 4- part proximal humerus fractures will be randomized to either open reduction and internal fixation with locked plating technology or non-operative management treatment arms. The primary outcome measure is the Constant Score at 24 months post-operative. Secondary outcome measures include the American Shoulder and Elbow Surgeon’s Score (ASES), EuroQol EQ-5D-5 L Health Questionnaire Score, short form PROMIS upper extremity score and IPAQ for the elderly score. Further outcome measures include assessment of the initial classification, displacement and angulation and the quality of surgical reduction via a standard computed tomography (CT) scan; rates of non-union, malunion, arthrosis, osteopenia or other complications including infection, nerve injury, intra-articular screw penetration, reoperation rates and hospital re-admission rates. Discussion The results of this trial will provide Level 1 evidence to guide decision-making in the treatment of proximal humerus fractures in the elderly population. Trial registration ClinicalTrials.gov NCT02362100 . Registered 5 Feb 2015.
The value of arthroscopy in the treatment of complex ankle fractures – a protocol of a randomised controlled trial
Background An anatomical reconstruction of the ankle congruity is the important prerequisite in the operative treatment of acute ankle fractures. Despite anatomic restoration patients regularly suffer from residual symptoms after these fractures. There is growing evidence, that a poor outcome is related to the concomitant traumatic intra-articular pathology. By supplementary ankle arthroscopy anatomic reduction can be confirmed and associated intra-articular injuries can be treated. Nevertheless, the vast majority of complex ankle fractures are managed by open reduction and internal fixation (ORIF) only. Up to now, the effectiveness of arthroscopically assisted fracture treatment (AORIF) has not been conclusively determined. Therefore, a prospective randomised study is needed to sufficiently evaluate the effect of AORIF compared to ORIF in complex ankle fractures. Methods/design We perform a randomised controlled trial at Munich University Clinic enrolling patients (18–65 years) with an acute ankle fracture (AO 44 A2, A3, B2, B3, C1 - C3 according to AO classification system). Patients meeting the inclusion criteria are randomised to either intervention group (AORIF, n  = 37) or comparison group (ORIF, n  = 37). Exclusion criteria are fractures classified as AO type 44 A1 or B1, pilon or plafond-variant injury or open fractures. Primary outcome is the AOFAS Score (American Orthopaedic Foot and Ankle Society). Secondary outcome parameter are JSSF Score (Japanese Society of Surgery of the Foot), Olerud and Molander Score, Karlsson Score, Tegner Activity Scale, SF-12, radiographic analysis, arthroscopic findings of intra-articular lesions, functional assessments, time to return to work/sports and complications. This study protocol is accordant to the SPIRIT 2013 recommendation. Statistical analysis will be performed using SPSS 22.0 (IBM). Discussion The subjective and functional outcome of complex ankle fractures is regularly unsatisfying. As these injuries are very common it is essential to improve the postoperative results. Potentially, arthroscopically assisted fracture treatment can significantly improve the outcome by addressing the intra-articular pathologies. Given the absolute lack of studies comparing AORIF to ORIF in complex ankle fractures, this randomised controlled trail is urgently needed to evaluate the effectiveness of additional arthroscopy. Trial registration ClinicalTrials.gov reference: NCT02449096 (Trial registration date: April 7th, 2015).
Fulfillment of expectations and patient satisfaction following surgical treatment of complex proximal tibial fractures
Aim The aim of this study was to investigate on fulfillment of expectations and patient satisfaction after surgical treatment of complex proximal tibial fractures. Methods In this prospective study 114 patients who suffered a complex tibial fracture (AO/OTA-Type B and C) were enrolled. At follow-up, based on the Hospital For Special Surgery-Knee Surgery Expectations Survey (HFSS-KSES), an individualized questionnaire was used to evaluate whether the preoperative formulated expectations had been fulfilled. In addition, condition of the knee joint (rated 0–4), overall satisfaction (rated 0–4) with the outcome, the Knee injury and Osteoarthritis Outcome Score (KOOS), and SF-12 was used. Results Fulfillment of expectations for abilty to run, to knee, and regain an intact status of the knee joint performed worst in the HFSS-KSE. Highest fulfillment was reached for psychological well-being and to interact socially. No statistical difference was found between the two fracture groups (AO/OTA-Type B vs. C). In the study cohort n = 81 patients (83.5%) were satisfied or very satisfied with the outcome. Mean satisfaction in the study cohort was 3.5. Satisfaction correlated highly significant with all items of the HFSS-KSE survey. Results vary in the different fracture groups. Satisfaction also correlates highly significant with the condition of the knee joint as well as with all dimensions of the KOOS score and the PCS of the SF-12 survey. Conclusion In patients who suffered a complex proximal tibial fracture, fulfillment of preoperative expectations is only limited. Nevertheless, overall satisfaction with the outcome is high, and correlates to a high degree with fulfillment of joint functionality and current health status. The fracture type does not influence these results.
Double reverse traction repositor assisted closed reduction and internal fixation versus open reduction and internal fixation for treatment of lateral tibial plateau fractures among the elderly
Background In elderly tibial plateau fractures (TPFs), the lateral condyles are involved frequently. This study aimed to compare the outcomes of open reduction and internal fixation (ORIF) and double reverse traction repositor (DRTR) assisted closed reduction and internal fixation (CRIF) in elderly patients with lateral TPFs. Methods From January 2015 to July 2020, we retrospectively reviewed 68 patients treated surgically at our trauma center for lateral TPFs (Schatzker type I-III). 31 patients were eventually assigned to the DRTR assisted CRIF group, whereas 37 patients were assigned to the ORIF group. The primary outcomes included surgical details, radiological assessment, follow-up knee function, and complications. Results The DRTR assisted CRIF group experienced a 43.6 mL decrease in intraoperative blood loss (161.3 ml vs 204.9 ml, p  = 0.033), and the operation duration was 32.1 min shorter than the ORIF group (83.8 min vs 115.9 min, p  < 0.001). There was no statistically significant difference in terms of widening of the tibia plateau (WTP), depth of articular depression (DAD), medial proximal tibial angle (MPTA) and posterior tibial slope angle (PTSA) immediately after surgery and at the last follow-up. No differences in malreduction ( p  = 0.566) or reduction loss ( p  = 0.623) were observed between the groups, and Lysholm and HSS scores were similar between the two groups (83.6 ± 15.8 vs 83.4 ± 5.1, p  = 0.934; 89.3 ± 7.8 vs 86.9 ± 6.2, p = 0.172; respectively). However, ORIF was associated with a greater increase in postoperative complications than DRTR assisted CRIF (3.2% vs 27%, p  = 0.008). Conclusion Both types of internal fixation provide good radiological outcomes and knee function in the treatment of lateral TPFs in the elderly. However, DRTR assisted CRIF has the advantage of a shorter duration of surgery, less blood loss, and fewer postoperative complications, and appears to be a better treatment option for elderly patients with lateral TPFs.
Analgesic effect of premixed nitrous oxide in postoperative rehabilitation for ankle fractures: study protocol for a randomized controlled trial
Background The prevalence of ankle fractures is increasing globally. Postoperative rehabilitation exercises constitutes an essential component of the surgical procedure. However, the severe pain in postoperative rehabilitation exercises remains a clinical problem. The objective of this study is to ascertain whether the administration of premixed nitrous oxide provides effective pain relief during the postoperative rehabilitation phase following the treatment of ankle fractures. Methods This study employed a single-center, randomized, double-blind controlled trial design. This study will enroll 100 patients. Patients undergoing rehabilitation exercises with acute pain (VAS ≥ 4) at least 1 month after ankle open reduction and internal fixation will be eligible for inclusion. Patients will be assigned in a 1:1 ratio through a randomization process to an intervention group receiving a pre-prepared nitrous oxide/oxygen mixture or a control group receiving oxygen. Rehabilitation therapy will perform by a professional rehabilitation therapist. The primary outcome is pain score, and the secondary outcomes include anxiety score, physiological indicators, side events, satisfaction from patients and medical staffs, acceptance, and residual pain after rehabilitation. Discussion The study is an in-depth examination of the analgesic effect of nitrous oxide applied to postoperative rehabilitation exercises of ankle fracture. If this method proves to be successful, it could be widely applied to patients in postoperative rehabilitation exercises for ankle fracture, providing a new idea for pain management in the field of postoperative rehabilitation. Trial registration Chinese Clinical Trial Register ChiCTR2400089379. Registered on September 9, 2024. https://www.chictr.org.cn/showproj.html?proj=236994
Trends in Surgical Management and Costs for Operative Treatment of Proximal Humerus Fractures in the Elderly
Proximal humerus fractures in the elderly are increasing in frequency as the population ages. The purpose of this study was to investigate surgical and cost trends in the Medicare population. The PearlDiver database was queried using diagnosis codes to identify Medicare recipients with proximal humerus fractures from 2005 to 2012. Surgical trends, demographics, and charge/reimbursement data were analyzed. There were 750,426 proximal humerus fractures in Medicare recipients during the 8-year period. Eighty-five percent of the fractures were treated nonoperatively; however, the percentage of operative vs nonoperative management increased significantly over time for all fractures, isolated fractures, and fracture dislocations. Open reduction and internal fixation (ORIF) was the most common surgical treatment and remained constant. Reverse total shoulder arthroplasty (RTSA) increased by 406% and hemiarthroplasty (HEMI) decreased by 47%. Compared with younger patients, older patients were more likely to undergo HEMI or RTSA than to undergo ORIF for isolated fractures and fracture dislocations. Charges and reimbursements from Medicare increased over time. The charge to reimbursement gap increased from 87% in 2005 to 104% in 2012. Charges were higher for RTSA than for ORIF or HEMI. Nonoperative management was the treatment of choice for 85% of proximal humerus fractures in the elderly; however, there was a trend toward higher rates of surgery. The RTSA rate increased and the HEMI rate decreased, while ORIF remained constant. There was an increasing charge to reimbursement ratio for all procedure types. [ Orthopedics. 2017; 40(4):e641–e647.]
The effect of topical TRanexamic Acid versus placebo on acute postoperative pain following Distal Radius fracture fixation: protocol for a randomised controlled trial at a quaternary care hand surgery centre – The TRADR study
IntroductionPostoperative pain management is a major concern for patients undergoing distal radius open reduction internal fixation (ORIF). Inadequate pain control negatively impacts patient’s satisfaction and may increase opioid use. Topical tranexamic acid (TXA) has been demonstrated as an effective intervention that reduced acute postoperative pain in total knee arthroplasty. There is no study evaluating the effects of TXA on acute postoperative pain for distal radius ORIF. This study aims to evaluate the effect of topical TXA administration during isolated distal radius ORIF on early postoperative pain.Methods and analysisThe effect of topical TRanexamic Acid versus placebo on acute postoperative pain following Distal Radius fracture fixation (TRADR) study is a randomised controlled double-blinded trial that will enrol 90 patients, 18 years of age or older, undergoing volar open reduction internal fixation. Patients will be randomly assigned to topical TXA versus topical saline (placebo) in a 1:1 ratio. The surgeon at the time of surgical closure after standard distal radius fixation will apply either 1 g of topical TXA (100 mg/mL; treatment group) or 10 mL of saline (control group) to the wound and let it sit for 5 min. Surgeons, patients, and outcome assessors will be blinded to the treatment group. The primary outcome is acute postsurgical pain as measured by the visual analogue scale (VAS). Pain outcomes will be between postoperative days 0 to 7, and at 2 and 6 weeks postsurgery. The secondary outcomes include opioid usage, unscheduled emergency visits, wrist swelling and adverse events.Ethics and disseminationThis study was approved by the University Health Network Research Ethics Board (REB 23–5708). The results of this trial will be disseminated through peer-reviewed journals and presented at related conferences. The principal investigator will communicate the results with patients who have indicated an interest in knowing the results.Trial registration numberClinicaltrials.gov NCT06384456, April 26, 2024; Pre-enrolment.Protocol versionVersion 2.0: August 26, 2024.