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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.

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.

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

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.

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.

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).

Background In the past several years, an increase in open reduction and internal fixation (ORIF) for intra-articular distal radius fractures has been observed. This technique leads to a quicker recovery of function compared to non-operative treatment. However, some patients continue to have a painful and stiff wrist postoperatively. Arthroscopically assisted removal of intra-articular fracture haematoma and debris may improve the functional outcomes following operative treatment of intra-articular distal radius fractures. The purpose of this randomised controlled trial is to determine the difference in functional outcome, assessed with the Patient-Rated Wrist Evaluation (PRWE) score, after ORIF with and without an additional wrist arthroscopy in adult patients with displaced complete articular distal radius fractures. Methods In this multicentre trial, adult patients with a displaced complete articular distal radius fracture are randomised between ORIF with an additional wrist arthroscopy to remove fracture haematoma and debris (intervention group) and conventional fluoroscopic-assisted ORIF (control group). The primary outcome is functional outcome assessed with the PRWE score after three months. Secondary outcomes are wrist function assessed with the Disability of the Arm, Shoulder and Hand (DASH) score, postoperative pain, range of motion, grip strength, complications and cost-effectiveness. Additionally, in the intervention group, the quality of reduction, associated ligamentous injuries and cartilage damage will be assessed. A total of 50 patients will be included in this study. Discussion Although ORIF of intra-articular distal radius fractures leads to a quicker resume of function compared to non-operative treatment, some patients continue to have a painful and stiff wrist postoperatively. We hypothesise that, due to the removal of fracture haematoma and debris by an additional arthroscopy, functional outcomes will be better compared to the non-arthroscopically treated group. Trial registration ClinicalTrials.gov, NCT02660515 . Registered on 13 January 2016.

Background Although Lisfranc injuries are uncommon, representing approximately 0.2% of all fractures, they are complex and can result in persistent pain, degenerative arthritis, and loss of function. Both open reduction and internal fixation (ORIF) and primary fusion have been proposed as treatment options for these injuries, but debate remains as to which approach is better. Questions/purposes We asked whether ORIF or primary fusion led to (1) fewer reoperations for hardware removal; (2) less frequent revision surgery; (3) higher patient outcome scores; and (4) more frequent anatomic reduction. Methods A systematic review was performed using the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines. Three trials met the criteria for inclusion within the meta-analysis. Qualifying articles for the meta-analysis had data extracted independently by two authors (NS, AF). The quality of each study was assessed using the Center for Evidence Based Medicine’s evaluation strategy; data were extracted from articles rated as good and fair: two and one article, respectively. Results The risk ratio for hardware removal was 0.23 (95% confidence interval [CI], 0.11–0.45; p < 0.001) indicating more hardware removal for ORIF than fusion. For other revision surgery, the risk ratio for ORIF was 0.36 (95% CI, 0.08–1.59; p = 0.18) favoring neither. Similarly, neither was favored using patient-reported outcomes; the standard mean difference was calculated to be 0.50 (95% CI, −2.13 to 3.12; p = 0.71). When considering the risk of nonanatomic alignment, neither was favored (risk ratio, 1.48; 95% CI, 0.34–6.38; p = 0.60). Conclusions The surgeon should consider the increased risk of hardware removal along with its associated morbidity and discuss this with the patient preoperatively when considering ORIF of Lisfranc injuries. Because no new trials have been performed since 2012, further randomized controlled trials will be needed improve our understanding of these interventions. Level of Evidence Level I, therapeutic study.

Background Minimally Invasive Plate Osteosynthesis (MIPO) has emerged as an option for the treatment of fractures; however, there is limited literature regarding its application in radius shaft fractures. The purpose of this study was to introduce a MIPO technique for treating radius shaft fractures and to compare its clinical and radiologic outcomes with those of open reduction and internal fixation using a plate (ORIF). Methods A retrospective analysis was conducted on 49 cases of diaphyseal radius fractures between March 2018 and November 2021. The MIPO group (20 patients) and ORIF group (29 patients) were treated by a single surgeon. Clinical outcomes were evaluated based on union rates, range of motion (ROM), and complications. Radiological assessments included fracture healing, ulnar variance, and alignment. Results Union was achieved in all cases in both groups. The union time was similar, with 13.1 weeks for the MIPO group and 12.6 weeks for the ORIF group. Forearm rotation was comparable between the two groups (MIPO: supination 87.3°, pronation 79.5°; ORIF: supination 87.4°, pronation 80.2°). Clinical outcomes were excellent in 92.3% of MIPO patients and 96.5% of ORIF patients. Ulnar variance was similar in both groups, indicating good alignment and preservation of length. No complications, such as infection or neurovascular injury, were observed in either group. Conclusion In our study, the MIPO technique for radius shaft fractures demonstrated clinically favorable outcomes without major complications. However, further research with larger sample sizes and longer follow-up periods is needed to fully evaluate the utility and long-term outcomes of the MIPO technique for radius shaft fractures. Clinical trial number Not applicable.

Background The optimal surgical technique for treating tibial plateau fractures remains controversial. This study aimed to compare the outcomes of arthroscopy-assisted reduction and internal fixation (ARIF) to those of open reduction and internal fixation (ORIF) in treating tibial plateau fractures. Methods This systematic review and meta-analysis were conducted to compare surgical outcomes between ARIF versus ORIF for patients with tibial plateau fractures. Relevant studies, comprising randomized controlled trials (RCTs) and non-RCTs, were identified through searches in Cochrane CENTRAL, PubMed, and Embase databases. Risk of bias assessments were conducted using the revised Cochrane risk-of-bias tool for RCTs (RoB 2.0), Newcastle Ottawa scales for non-RCTs, and Joanna Briggs Institute Critical Appraisal Checklist for case series studies. Data synthesis utilized a random-effects model meta-analysis. The primary outcome assessed was functional outcomes, with complications considered as secondary outcomes. Results There were fifteen studies (one RCT and fourteen non-RCTs) included in this study, comprising a total of 969 participants (548 in the ARIF group and 421 in the ORIF group). Although patients in the ARIF group showed a trend towards better functional outcomes compared to the ORIF group, the difference was not statistically significant (Hospital for special surgery score, mean difference (MD) = 5.13, 95% confidence interval (CI)=-1.67 to 11.92, I²=83%; Knee society score, MD = 5.84, 95% CI=-1.18 to 12.86, I²=74%). No significant differences were noted in infection, stiffness, DVT, and overall complications between two groups. The ARIF group included ten case series studies with a total of 302 patients. The pooled mean Rasmussen Radiological Score was 16.59 (95% CI, 15.72 to 17.50), and the pooled mean Rasmussen Clinical Score was 27.38 (95% CI, 26.45 to 28.33). Conclusion The findings of this study reveal no significant difference in clinical outcomes and complication rates between ARIF and ORIF. Additionally, this study found that the complication rate for patients undergoing ARIF falls within previously reported ranges. This suggests that ARIF is a reliable and effective surgical option for treating tibial plateau fractures, even in cases involving high-energy trauma.