Safety of expedited-surgery protocols in anticoagulant-treated patients with hip fracture: a systematic review and meta-analysis.

BACKGROUND: Perioperative management of patients with hip fracture patients receiving oral anticoagulants requires navigating the risks associated with surgical delay and perioperative hemostasis. The aim of this systematic review and meta-analysis was to evaluate the effect of expedited-surgery protocols on time to surgery and perioperative outcomes in anticoagulant-treated patients with hip fracture. METHODS: We searched MEDLINE, Embase and CENTRAL from inception to May 5, 2020, to identify English-language studies reporting outcomes after expedited hip fracture surgery in patients receiving vitamin K antagonists (VKAs) or direct oral anticoagulants (DOACs) before hospital admission. We performed a meta-analysis using Mantel-Haenszel weighting for dichotomous variables and inverse variance weighting for continuous variables. RESULTS: Among the 4253 citations identified, 14 studies were included. In the 6 studies eligible for meta-analysis, compared to hip fracture surgery before implementation of a VKA-reversal protocol, surgery after implementation of such a protocol was associated with a significant reduction in time to surgery (mean difference 45.31 h, 95% confidence interval [CI] 15.81 h to 74.80 h). Expedited surgery (within 48 h) in patients who received DOACs preoperatively was not associated with increased surgical duration (mean difference -7.29 min, 95% CI -22.5 min to 7.95 min) or 30-day mortality (odds ratio [OR] 1.30, 95% CI 0.49 to 3.89) compared to patients who did not receive anticoagulants (control patients). However, expedited surgery in DOAC-treated patients was associated with an increased blood transfusion risk compared to control patients (OR 0.58, 95% CI 0.36 to 0.96). CONCLUSION: Implementing a VKA-reversal protocol for patients with hip fracture is effective in decreasing time to surgery, without an increased bleeding risk. Performing hip fracture surgery within 48 hours in DOAC-treated patients is also safe, with a small increase in blood transfusion risk.

Restoration of Stiffness During Fracture Healing at the Distal Radius, Using HR-pQCT and Finite Element Methods.

Finite element analysis (FE) coupled with high-resolution peripheral quantitative computed tomography (HR-pQCT) allows for noninvasive in vivo assessment of fracture stiffness at peripheral locations including the distal radius. Previous studies have reported the ability of FE analysis to capture significant longitudinal changes in fracture stiffness. We hypothesized that continuum-based FE methods are necessary to capture significant changes in FE-estimated stiffness in men and women, with closed reductions and casting, over the course of their fracture healing process. The primary aim of the study was to evaluate the performance of 3 micro-FE (µFE) methods, 2 density-based (continuum) methods, and a homogeneous method. A total of 30 participants with stable distal radius fractures completed follow-ups at 2, 4, 6, 8, 12, and 26 weeks postfracture. Participants had their fractured wrist scanned using HR-pQCT at each follow-up; the contralateral wrist was also scanned at the initial assessment to represent baseline conditions. Images were used to generate continuum and homogeneous µFE models. Uniaxial compression and torsional tests were completed, with apparent stiffness determined as the primary outcome measure. Stiffness of the fractured wrist was compared to stiffness of the uninjured contralateral wrist to quantify the change in stiffness. Days since fracture significantly predicted change in stiffness for continuum and homogeneous µFE methods (p < 0.05). Continuum µFE methods appeared to account for partially mineralized tissues, resulting in a graduated recovery of stiffness (1% per week). Homogeneous µFE methods were more sensitive to stages of healing progression, resulting in a faster recovery of stiffness (3% per week). Our findings demonstrate the capability of µFE to capture the restoration of stiffness at the fractured side to prefracture stiffness in men and women, up to 6 months postfracture.

Downhill skiing following total knee arthroplasty: a survey of Alberta orthopedic surgeons.

Background: In older adults facing knee arthroplasty, the ability to resume downhill skiing postoperatively is unclear. This study aimed to determine the perspectives of Alberta orthopedic surgeons and senior residents regarding downhill skiing after total knee arthroplasty (TKA) or unicompartmental knee arthroplasty (UKA). Methods: In May 2019, a Web-based survey was sent through the Alberta Orthopaedic Society to poll orthopedic surgeons performing arthroplasty and senior orthopedic residents (postgraduate year 4 or 5) in Alberta regarding the permissibility of downhill skiing after TKA or UKA. The survey also elicited information regarding under which conditions or restrictions, if any, surgeons would allow patients to return to downhill skiing, whether these recommendations were evidence based, and whether surgeons had seen complications from downhill skiing in their patients who had undergone knee arthroplasty. Results: Of the 41 respondents, 21 (51%) were full-time fellowship-trained orthopedic surgeons, 15 (37%) were specialists with some arthroplasty in their practice, and 5 (12%) were orthopedic residents. Ten of 40 respondents (25%) would allow unrestricted downhill skiing after TKA, and 1 (2%) would not allow any skiing at all. The remaining 29 (72%) indicated that they might allow downhill skiing under specific conditions, with the top 3 being limitations on speed and intensity (29 [71%]), return of full range of motion and strength in the operative knee (26 [63%]), and years of downhill ski experience (23 [56%]). Fourteen respondents (34%) would allow unrestricted downhill skiing after UKA, and 27 (66%) would allow skiing with the same top 3 conditions as for TKA. Thirty-two respondents (78%) reported that their decisions were not evidence based, and 35 (85%) had never seen complications from downhill skiing after TKA or UKA. Conclusion: Alberta orthopedic surgeons and senior residents are cautious regarding skiing after knee arthroplasty. The majority reported that their restrictions were not evidence based, which indicates the need for further investigation to develop an approach for surgeons to consistently and safely address return to downhill skiing after TKA or UKA.

Contexte: Chez les adultes âgés qui doivent subir une arthroplastie du genou, la capacité de reprendre la pratique du ski alpin n'a pas été clairement évaluée. Cette étude visait à clarifier le point de vue des chirurgiens et résidents séniors en orthopédie de l'Alberta au sujet de la pratique du ski alpin après une intervention pour prothèse totale du genou (PTG) ou prothèse partielle du genou (PPG). Méthodes: En mai 2019, un sondage en ligne a été envoyé par l'entremise de l'Alberta Orthopaedic Society afin d'interroger les chirurgiens et résidents séniors (résidents 4 ou 5) en orthopédie pratiquant des arthroplasties en Alberta au sujet de l'autorisation à recommencer le ski alpin après une PTG ou une PPG. Le sondage portait aussi sur les conditions ou les restrictions, le cas échéant, imposées aux patients par leurs chirurgiens pour leur permettre de recommencer à skier, si ces recommandations étaient fondées sur des données probantes, et si les chirurgiens avaient observé des complications chez leurs patients ayant repris le ski après une PTG ou une PPG. Résultats: Sur les 41 répondants, 21 (51 %) étaient des médecins spécialistes en chirurgie orthopédique à temps complet, 15 (37 %) étaient des spécialistes ayant déjà effectué des arthroplasties dans le cadre de leur pratique et 5 (12 %) étaient des résidents en orthopédie. Dix répondants sur 40 (25 %) disaient qu'ils permettraient la pratique du ski alpin sans restrictions après la PTG et 1 (2 %) ne la permettrait pas du tout. Les 29 autres (72 %) ont indiqué qu'ils autoriseraient la pratique du ski alpin à certaines conditions, les 3 principales étant le contrôle de la vitesse et de l'intensité (29 [71 %]), le retour de la pleine amplitude de mouvement et de la force au genou opéré (26 [63 %]) et le nombre d'années d'expérience en ski alpin (23 [56 %]). Quatorze répondants (34 %) permettraient la reprise du ski alpin sans restrictions après la PPG et 27 (66 %) l'autoriseraient en appliquant les 3 mêmes conditions que pour la PTG. Trente-deux répondants (78 %) ont indiqué que leur décision ne reposait pas sur des données probantes et 35 (85 %) n'avaient observé aucune complication après la reprise de la pratique du skin suite à une PTG ou une PPG. Conclusion: Les chirurgiens et les résidents séniors en orthopédie de l'Alberta émettent des réserves relativement à la reprise de la pratique du skin après une arthroplastie du genou. Chez la majorité, les restrictions préconisées ne reposent pas sur des données probantes, ce qui indique que la recherche à ce sujet mérite d'être approfondie afin qu'on puisse élaborer une approche cohérente et sécuritaire en orthopédie pour la reprise de la pratique du ski alpin après une PTG ou une PPG.

Identification of hypercoagulability with thrombelastography in patients with hip fracture receiving thromboprophylaxis.

Background: Venous thromboembolism (VTE) is the second most common complication after hip fracture surgery. We used thrombelastography (TEG), a whole-blood, point-of-care test that can provide an overview of the clotting process, to determine the duration of hypercoagulability after hip fracture surgery. Methods: In this prospective study, consecutive patients aged 51 years or more with hip fractures (trochanteric region or neck) amenable to surgical treatment who presented to the emergency department were eligible for enrolment. Thrombelastography, including calculation of the coagulation index (CI) (combination of 4 TEG parameters for an overall assessment of coagulation) was performed daily from admission until 5 days postoperatively, and at 2 and 6 weeks postoperatively. All patients received 28 days of thromboprophylaxis. We used single-sample t tests to compare mean maximal amplitude (MA) values (a measure of clot strength) to the hypercoagulable threshold of greater than 65 mm, a predictor of in-hospital VTE. Results: Of the 35 patients enrolled, 11 (31%) were hypercoagulable on admission based on an MA value greater than 65 mm, and 29 (83%) were hypercoagulable based on a CI value greater than 3.0; the corresponding values at 6 weeks were 23 (66%) and 34 (97%). All patients had an MA value greater than 65 mm at 2 weeks. Patients demonstrated normal coagulation on admission (mean MA value 62.2 mm [standard deviation (SD) 6.3 mm], p = 0.01) but became significantly hypercoagulable at 2 weeks (mean 71.6 mm [SD 2.6 mm], p < 0.001). There was a trend toward persistent hypercoagulability at 6 weeks (mean MA value 66.2 mm [SD 3.8 mm], p = 0.06). Conclusion: More than 50% of patients remained hypercoagulable 6 weeks after fracture despite thromboprophylaxis. Thrombelastography MA thresholds or a change in MA over time may help predict VTE risk; however, further study is needed.

Contexte: La thromboembolie veineuse (TEV) est la deuxième complication la plus courante après une chirurgie pour fracture de la hanche. Nous avons eu recours à la thromboélastographie, un test de sang total effectué au point d'intervention et donnant une idée du processus de coagulation, pour évaluer la durée de l'hypercoagulabilité à la suite d'une chirurgie pour fracture de la hanche. Méthodes: Cette étude prospective a été menée auprès de patients consécutifs admissibles de 51 ans et plus qui se sont présentés à l'urgence pour une fracture de la hanche (région trochantérienne ou col du fémur) pouvant faire l'objet d'un traitement chirurgical. Une thromboélastographie (TEG), qui comprenait le calcul de l'indice de coagulation (IC) [combinaison de 4 paramètres du TEG permettant une évaluation globale de la coagulation], a été réalisée chaque jour, de l'admission au cinquième jour postopératoire, de même qu'à 2 et à 6 semaines postopératoires. Tous les patients ont suivi une thromboprophylaxie de 28 jours. Nous avons réalisé des tests t pour échantillon unique afin de comparer l'amplitude maximale (AM) moyenne (une mesure de la résistance d'un caillot) au seuil d'hypercoagulabilité de plus de 65 mm, un prédicteur de TEV à l'hôpital. Résultats: Des 35 patients recrutés, 11 (31 %) présentaient une hypercoagulabilité à l'admission selon une AM supérieure à 65 mm, et 29 (83 %) présentaient une hypercoagulabilité selon un IC supérieur à 3,0; les valeurs correspondantes à 6 semaines étaient de 23 (66 %) et de 34 (97 %), respectivement. Tous les patients avaient une AM de plus de 65 mm à 2 semaines. Dans l'ensemble, les patients avaient une coagulation normale à l'admission (AM moyenne 62,2 mm [écart type (E.T.) 6,3 mm], p = 0,01), mais présentaient une hypercoagulabilité importante à 2 semaines (moyenne 71,6 mm [E.T. 2,6 mm], p < 0,001). L'hypercoagulabilité avait tendance à persister à 6 semaines (AM moyenne 66,2 mm [E.T. 3,8 mm], p = 0,06). Conclusion: Malgré la thromboprophylaxie, plus de 50 % des patients présentaient toujours une hypercoagulabilité 6 semaines après leur fracture. Les seuils d'AM à la thromboélastographie et les changements de l'AM au fil du temps pourraient aider à prédire le risque de TEV, mais d'autres études sur le sujet sont nécessaires.

A sub-meniscal arthrotomy improves the medium-term patient outcome of tibial plateau fractures.

PURPOSE: This trial was conducted to determine the medium-term functional outcome of displaced tibial plateau fracture patients treated with closed fluoroscopic assisted reduction and internal fixation (CRIF) versus patients treated with standard open reduction with sub-meniscal arthrotomy and internal fixation (ORIF). METHODS: A prospective trial was conducted in adult patients with displaced AO/OTA 41 B and 41 C tibial plateau fractures. Patients were assigned to treatment based upon the standard treatment of the surgeon involved following the call schedule for the day, either CRIF or ORIF. Postoperative radiographs and CT were performed on all patients and patients were followed for a minimum of 2 years. Primary outcome measures were the KOOS, SMFA and SF-36. RESULTS: Seventy patients were recruited with 2 year follow-up on 35 patients in the CRIF group and 27 patients in the ORIF group. Postoperative CT scans showed that reductions were better with the ORIF group especially in the posterolateral quadrant as compared to the CRIF group. The frequency of mal-reductions was higher in the CRIF group. The KOOS, at two years, showed that the CRIF had significantly less good outcomes in the subcategories of SPORT (p = 0.03) and QOL (p = 0.01) measurements. CONCLUSIONS: ORIF with a sub-meniscal arthrotomy provides better quality reductions and better medium-term results as compared to CRIF for tibial plateau fractures. This may provide more long-term benefit from osteoarthritic symptoms in this patient group. LEVEL OF EVIDENCE: Therapeutic, Level 2.

The effect of three-dimensional computed tomography reconstructions on preoperative planning of tibial plateau fractures: a case-control series.

BACKGROUND: Tibial plateau fractures are a common intra-articular injury for which computed tomography (CT) scans are routinely used for preoperative planning. Three-dimensional reconstructions of CT scans have been increasingly investigated in recent years, however their role has yet to be defined. We wish to investigate the role of three-dimensional computed tomography reconstructions (3D-CT) in the preoperative planning of tibial plateau fractures. METHODS: Twelve cases of tibial plateau fractures including plain film radiographs and conventional CT scans were distributed to 21 observers (orthopaedic residents and consultants). The observers filled out a preoperative plan checklist created for this study. Three months later the same cases were distributed, in random order, this time including 3D-CT reconstructions. The same preoperative checklists were completed, and compared to the previous checklists. RESULTS: The preoperative plan checklist was able to detect differences between cases and between observers. No significant differences were detected between the total plan scores when comparing conventional CT to 3D-CT. Sub-analysis of plan specifics (incisions, hardware, adjuncts) was also not significantly different. The level of training of the observer or the fracture complexity did not affect these results. CONCLUSIONS: No significant changes were made to observer's preoperative plans with the addition of 3D-CT. 3D-CT reconstructions come at a cost to the system, and therefore their usefulness should be investigated prior to widespread use. Our study demonstrates that the addition of 3D-CT reconstructions to the preoperative workup of tibial plateau fractures did not change management plans when compared to plans made using traditional CT-scans.

Biomechanical Evaluation of Different Plate Configurations for Midshaft Clavicle Fracture Fixation: Single Plating Compared with Dual Mini-Fragment Plating.

Background: Dual-plate constructs have become an increasingly common fixation technique for midshaft clavicle fractures and typically involve the use of mini-fragment plates. The goal of this technique is to reduce plate prominence and implant irritation. However, limited biomechanical data exist for these lower-profile constructs. The study aim was to compare dual mini-fragment orthogonal plating with small-fragment clavicle plates for biomechanical noninferiority and to determine if an optimal plate configuration could be identified using a cadaveric model. Methods: Twenty-four cadaveric clavicles were randomized to 1 of 6 groups, stratified by computed tomography-based bone mineral content (BMC): precontoured superior or anterior fixation using a single 3.5-mm Locking Compression Plate (LCP), and 4 different dual-plating constructs utilizing 2.4-mm and 2.7-mm Adaptation plates or LCPs. An inferior butterfly fracture was created. Axial, torsional, and bending (anterior and superior surface loading) stiffnesses were determined through nondestructive cyclic testing, followed by a load-to-failure test in 3-point superior surface bending. Results: For axial stiffness, the 2 dual-plate constructs with a superior 2.4-mm and anterior 2.7-mm plate (either Adaptation or LCP) were significantly stiffer than the other 4 constructs (p = 0.021 and p = 0.034). For both superior and anterior bending, the superior 2.4-mm and anterior 2.7-mm plate constructs were significantly stiffer when compared with the 3.5-mm superior plate (p = 0.043). No significant differences were found in torsional stiffness or load to failure between the different constructs. Conclusions: Dual plating using mini-fragment plates is biomechanically superior for the fixation of midshaft clavicle fractures when compared with a single, superior, 3.5-mm plate and has biomechanical properties similar to those of a 3.5-mm plate placed anteriorly. With the exception of axial stiffness, no significant differences were found when different dual-plating constructs were compared with each other. Clinical Relevance: This study validates the use of dual plating for midshaft clavicle fractures.

Improvements in radiographic and clinical assessment of distal radius fracture healing by FE-estimated bone stiffness.

Bone strength determined from finite element (FE) modelling provides an estimate of fracture healing progression following a distal radius fracture (DRF), but how these measures relate to patient-reported outcomes and functional outcomes remains unknown. We hypothesized that changes in bone stiffness and bone mineral density measured using high-resolution peripheral quantitative computed tomography (HR-pQCT) are associated with clinically available measures of functional and patient-reported outcomes. We also aimed to identify which clinical outcome measures best predict fracture stiffness and could therefore be used to inform cast removal. Participants (n = 30) with stable distal radius fractures were followed for two week intervals from the time of fracture until two months post-fracture, then at three months and six months post-fracture. At each follow-up, participants underwent clinical, radiographic, and functional assessments, as well as had their fractured wrist scanned using HR-pQCT. Recovery of bone stiffness during fracture healing was determined from micro-FE (µFE) models generated from HR-pQCT image data. During the DRF healing process, significant longitudinal changes were found in µFE-estimated stiffness, patient-reported outcomes, grip strength, range of motion (ROM), tenderness, number of cortices healed based on radiographs, and fracture line visibility (p < 0.05); however, no significant change was detected in HR-pQCT based total bone mineral density. Patient-reported outcomes, such as the Patient-Rated Wrist Evaluation (PRWE) and the Quick Disability of the Arm, Shoulder and Hand (QuickDASH) questionnaire, correlated strongly with µFE-estimated stiffness (0.61 ≥ rm ≥ 0.66). Based on µFE-estimated stiffness, PRWE and QuickDASH are the best predictors of stiffness recovery (p < 0.05) and may be used to guide duration of cast immobilization in the clinical setting.

Effect of oral anticoagulant use on surgical delay and mortality in hip fracture.

AIMS: Current guidelines recommend surgery within 48 hours among patients presenting with hip fractures; however, optimal surgical timing for patients on oral anticoagulants (OACs) remains unclear. Individual studies are limited by small sample sizes and heterogeneous outcomes. The aim of this study was to conduct a systematic review and meta-analysis to summarize the effect of pre-injury OACs on time-to-surgery (TTS) and all-cause mortality among older adults with hip fracture treated surgically. METHODS: We searched MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials (CENTRAL) from inception to 14 October 2019 to identify studies directly comparing outcomes among hip fracture patients receiving direct oral anticoagulants (DOACs) or vitamin K antagonists (VKAs) prior to hospital admission to hip fracture patients not on OACs. Random effects meta-analyses were used to pool all outcomes (TTS, in-hospital mortality, and 30-day mortality). RESULTS: A total of 34 studies (involving 39,446 patients) were included in our systematic review. TTS was 13.7 hours longer (95% confidence interval (CI) 9.8 to 17.5; p < 0.001) among hip fracture patients on OACs compared to those not on OACs. This translated to a three-fold higher odds of having surgery beyond the recommended 48 hours from admission (odds ratio (OR) 3.0 (95% CI 2.1 to 4.3); p = 0.001). In-hospital mortality was higher (OR 1.4 (95% CI 1.0 to 1.8); p < 0.03) among anticoagulated patients. Among studies comparing anticoagulants, there was no statistically significant difference in time-to-surgery between patients taking a DOAC compared to a VKA. CONCLUSION: Patients presenting with a hip fracture who were taking OACs prior to injury experience a delay in time-to-surgery and higher mortality than non-anticoagulated patients. Patients on DOACs may be at risk of further delays. Evaluating expedited surgical protocols in hip fracture patients on OACs is an urgent priority, with the potential to decrease morbidity and mortality in this group of high-risk patients. Cite this article: Bone Joint J 2021;103-B(2):222-233.

Effect of oral anticoagulants on hemostatic and thromboembolic complications in hip fracture: A systematic review and meta-analysis.

BACKGROUND: Hip fracture patients on oral anticoagulants (OACs) experience increased time-to-surgery and higher mortality compared to non-anticoagulated patients. However, it is unclear whether pre-injury OAC status and its associated operative delay are associated with worsening of peri-operative hemostasis or an increased risk of postoperative thromboembolism. METHODS: We performed a systematic review to identify studies that directly compared hemostatic and thromboembolic outcomes among hip fracture patients on an OAC prior to admission with those not on anticoagulants. Random effects meta-analyses were used to pool all outcomes of interest (estimated blood loss, transfusion requirements, and postoperative thromboembolism). RESULTS: Twenty-one studies involving 21 417 patients were included. Estimated blood loss was higher among patients presenting with OACs compared to those not anticoagulated (mean difference 31.0 mL, 95% confidence interval [CI] 6.2-55.7). Anticoagulated patients also had a 1.3-fold higher risk of receiving red blood cell transfusions (odds ratio [OR] 1.34, 95% CI 1.20-1.51); however, rates of postoperative thromboembolism were similar regardless of anticoagulation status (OR 0.96, 95% CI 0.40-2.79 for venous thromboembolism; OR 0.58, 95% CI 0.25-1.36 for arterial thromboembolism). No subgroup effect was found based on anticoagulant type or degree of surgical delay. CONCLUSION: Hip fracture patients on OACs experience increased surgical blood loss and higher risk of red blood cell transfusions. However, the degree of surgical delay did not mitigate this risk, and there was no difference in postoperative thromboembolism. The impact of appropriate, timely OAC reversal on blood conservation and expedited surgery in anticoagulated hip fracture patients warrants urgent evaluation.

Evaluating the Utility of the Lateral Elbow Radiograph in Central Articular Olecranon Reduction: An Anatomic and Radiographic Study.

OBJECTIVES: The surgical reduction of intra-articular olecranon fractures is judged primarily on the lateral elbow radiograph, as orthogonal imaging of the articular surface is not obtainable. We sought to determine surgeon accuracy in identifying intra-articular olecranon malreductions on the lateral elbow radiograph. METHODS: Six human fresh-frozen cadaveric elbow specimens were sagittally sectioned in 5-mm increments after olecranon dissection, preservation of soft tissue envelope, and rigid fixation of the elbow in an external fixator. Three patterns of central intra-articular olecranon malreduction were created in each elbow using a ruler and bone saw. Perfect lateral elbow radiographs were taken of each malreduction, and these images were randomized along with x-rays of normal cadaveric olecranons. The image series was presented to 4 masked trauma-trained surgeons to determine whether the olecranon was malreduced or anatomic. Surgeons interpreted the same image series on 2 separate occasions separated by 6 weeks. Percent correct was recorded, and the interobserver and intraobserver reliability was calculated. RESULTS: Orthopedic trauma surgeons correctly identified olecranon malreductions only 73% of the time on the lateral elbow radiograph. Interobserver agreement was moderate for the first review of images and fair for the second review, with respective Fleiss Kappa values of 0.43 and 0.28. Intrarater reliability revealed moderate agreement with Cohen's Kappa value ranging from 0.56 to 0.66. CONCLUSIONS: Intra-articular olecranon malreductions are inconsistently recognized by trauma surgeons on the lateral elbow radiograph. Therefore, articular incongruity may still be present after surgical fixation of comminuted olecranon fractures. We must further define the radiographic anatomic representation of the articular olecranon to improve surgical reduction and clinical outcomes.

Single-Screw Fixation Compared With Double Screw Fixation for Treatment of Medial Malleolar Fractures: A Prospective Randomized Trial.

OBJECTIVES: To determine whether single or double screw (DS) fixation of medial malleolar fractures results in better long-term health outcomes. DESIGN: Randomized clinical trial; sealed envelope technique. SETTING: Level 1 Trauma Hospital at University of Calgary, Canada. PATIENTS: One hundred forty patients were randomized to receive either 1 or 2 screws to reduce a medial malleolar fracture. Thirteen patients were excluded because of loss to follow-up (n = 127). INTERVENTION: Surgical fixation of the medial malleolar fracture was performed using 1 or 2 stainless steel screws. MAIN OUTCOME MEASUREMENTS: Primary outcome was comparison of physical functioning summary score on Short Form 36 questionnaires between patients in the 2 groups. Secondary objectives were to compare the Ankle Hindfoot Scale and operating room time. Clinical and radiographic assessment occurred at the time of injury and 2, 6 weeks, 3, 6, 12, and 24 months postoperatively. RESULTS: Fourteen patients crossed over from the DS group to the single screw (SS) group based on intraoperative decisions by the surgeon (fragment too small for 2 screws), leaving the SS (n = 75) and DS groups (n = 52). There was no difference in the operating room time, SF36, or Ankle Hindfoot Scale at all follow-up time points. CONCLUSIONS: SS medial malleolar fixation provides an equally safe and effective method of fracture care as compared to DS fixation. Twenty percent of patients receiving 2 screws can be expected to crossover to receive SS fixation as a safer alternative. LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.