Three week versus six week immobilisation for stable Weber B type ankle fractures: randomised, multicentre, non-inferiority clinical trial.
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PROVIDER: S-EPMC6880924 | biostudies-literature | 2019 Feb
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Three week versus six week immobilisation for stable Weber B type ankle fractures: randomised, multicentre, non-inferiority clinical trial.
BMJ (Clinical research ed.) 20190219
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Project description:ObjectiveTo determine whether treatment of isolated stable Weber B type ankle fractures with a cast or a simple orthotic device for three weeks produces non-inferior outcomes compared with conventional immobilisation in a cast for six weeks.DesignRandomised, pragmatic, non-inferiority, clinical trial with blinded outcome assessment.SettingTwo major trauma centres in Finland, 22 December 2012 to 6 June 2016.Participants247 skeletally mature patients aged 16 years or older with an isolated Weber B type fibula fracture and congruent ankle mortise in static ankle radiographs.InterventionsParticipants were randomly allocated to conventional six week cast immobilisation (n=84) or three week treatment either in a cast (n=83) or in a simple orthosis (n=80).Main outcome measuresThe primary, non-inferiority, intention-to-treat outcome was the Olerud-Molander Ankle Score at 12 months (OMAS; range 0-100; higher scores indicate better outcomes and fewer symptoms). The predefined non-inferiority margin for the primary outcome was -8.8 points. Secondary outcomes were ankle function, pain, quality of life, ankle motion, and radiographic outcome. Follow-up assessments were performed at 6, 12, and 52 weeks.Results212 of 247 randomised participants (86%) completed the study. At 52 weeks, the mean OMAS was 87.6 (SD 18.3) in the six week cast group, 91.7 (SD 12.9) in the three week cast group, and 89.8 (SD 18.4) in the three week orthosis group. The between group difference at 52 weeks for the three week cast versus six week cast was 3.6 points (95% confidence interval -1.9 to 9.1, P=0.20), and for the three week orthosis versus six week cast was 1.7 points (-4.0 to 7.3, P=0.56). In both comparisons, the confidence intervals did not include the predefined inferiority margin of -8.8 points. The only statistically significant between group differences observed in the secondary outcomes and harms in the two primary comparisons were slight improvement in ankle plantar flexion and incidence of deep vein thrombosis, both in the three week orthosis group versus six week cast group.ConclusionImmobilisation for three weeks with a cast or orthosis was non-inferior to conventional cast immobilisation for six weeks in the treatment of an isolated stable Weber B type fracture.Trial registrationClinicalTrials.gov NCT01758835.
| S-EPMC6342249 | biostudies-literature
Project description:AimsTreatment of Weber B ankle fractures that are stable on weightbearing radiographs but unstable on concomitant stress tests (classified SER4a) is controversial. Recent studies indicate that these fractures should be treated nonoperatively, but no studies have compared alternative nonoperative options. This study aims to evaluate patient-reported outcomes and the safety of fracture treatment using functional orthosis versus cast immobilization.MethodsA total of 110 patients with Weber B/SER4a ankle fractures will be randomized (1:1 ratio) to receive six weeks of functional orthosis treatment or cast immobilization with a two-year follow-up. The primary outcome is patient-reported ankle function and symptoms measured by the Manchester-Oxford Foot and Ankle Questionnaire (MOxFQ); secondary outcomes include Olerud-Molander Ankle Score, radiological evaluation of ankle congruence in weightbearing and gravity stress tests, and rates of treatment-related adverse events. The Regional Committee for Medical and Health Research (approval number 277693) has granted ethical approval, and the study is funded by South-Eastern Norway Regional Health Authority (grant number 2023014).DiscussionRandomized controlled trials are needed to evaluate alternative nonoperative treatment options for Weber B/SER4a ankle fractures, as current clinical guidelines are based on biomechanical reasoning. The findings will be shared through publication in peer-reviewed journals and presentations at conferences.
| S-EPMC10508240 | biostudies-literature
Project description:ObjectivesTo assess function, quality of life, resource use, and complications in adults treated with plaster cast immobilisation versus a removable brace for ankle fracture.DesignMulticentre randomised controlled trial.Setting20 trauma units in the UK National Health Service.Participants669 adults aged 18 years and older with an acute ankle fracture suitable for cast immobilisation: 334 were randomised to a plaster cast and 335 to a removable brace.InterventionsA below the knee cast was applied and ankle range of movement exercises started on cast removal. The removable brace was fitted, and ankle range of movement exercises were started immediately.Main outcome measuresPrimary outcome was the Olerud Molander ankle score at 16 weeks, analysed by intention to treat. Secondary outcomes were Manchester-Oxford foot questionnaire, disability rating index, quality of life, and complications at 6, 10, and 16 weeks.ResultsThe mean age of participants was 46 years (SD 17 years) and 381 (57%) were women. 502 (75%) participants completed the study. No statistically significant difference was found in the Olerud Molander ankle score between the cast and removable brace groups at 16 weeks (favours brace: 1.8, 95% confidence interval -2.0 to 5.6). No clinically significant differences were found in the Olerud Molander ankle scores at other time points, in the secondary unadjusted, imputed, or per protocol analyses.ConclusionsTraditional plaster casting was not found to be superior to functional bracing in adults with an ankle fracture. No statistically difference was found in the Olerud Molander ankle score between the trial arms at 16 weeks.Trial registrationISRCTN registry ISRCTN15537280.
| S-EPMC8256800 | biostudies-literature
Project description:BackgroundCurrently, non- or minimally displaced distal radius fractures are treated by 3 to 5 weeks of cast immobilisation. Many patients with a distal radius fracture suffer from long-term functional restrictions, which might be related to stiffness due to cast immobilisation. Current literature indicates that 1 week of immobilisation might be safe; however, no level 1 evidence is available. This trial aims to compare 1 week of brace immobilisation with 3 weeks of cast immobilisation in patients with distal radius fractures that do not need reduction.MethodsThe aim of this trial is to evaluate the non-inferiority of 1 week of brace immobilisation in patients with non- or minimally displaced distal radius fractures. A two-armed single blinded multicentre randomised clinical trial will be conducted in three hospitals. Adult patients, between 18 and 50 years old, independent for activities of daily living, with a non- or minimally displaced distal radius fracture can be included in this study. The intervention group is treated with 1 week of brace immobilisation, and the control group with 3 weeks of cast immobilisation. Primary outcome is the patient-reported outcome measured by the Patient-Related Wrist Evaluation score (PRWE) at 6 months. Secondary outcomes are patient-reported outcome measured by the Quick Disabilities of the Arm, Shoulder and Hand score at 6 weeks and 6 months, PRWE at 6 weeks, range of motion, patient-reported pain score measured by VAS score, radiological outcome (dorsal/volar tilt, radial height, ulnar variance, presence of intra-articular step off), complications and cost-effectiveness measured by the EuroQol 5 Dimension questionnaire, Medical Consumption Questionnaire and Productivity Cost Questionnaire.DiscussionThis study will provide evidence on the optimal period of immobilisation in non-operatively treated displaced and reduced distal radius fractures. Both treatment options are accepted treatment protocols and both treatment options have a low risk of complications. Follow-up will be according to the current treatment protocol. This study will provide level 1 evidence on the optimal period and way of immobilisation for non- or minimally displaced distal radius fractures in adult patients.Trial registrationABR 81638 | NL81638.029.22 | www.toetsingonline.nl . 18th of October 2023.
| S-EPMC11571880 | biostudies-literature
Project description:BackgroundLateral talar subluxation (LTS) was introduced as a measurement tool for evaluating isolated Weber B ankle fractures, with LTS >4 mm on gravity stress (GS) radiographs possibly indicating need for surgery. This study reviews LTS measurements in nonoperatively managed isolated Weber B fibula fractures to further investigate the validity of this previously stated cutoff.MethodsThe senior authors previously reported outcomes of a novel algorithm for nonoperative management of isolated Weber B ankle fractures. Outcome scores reported include American Orthopaedic Foot & Ankle Society (AOFAS) hindfoot, Olerud-Molander (OMA), Foot and Ankle Ability Measure for activities of daily living (FAAM/ADL), and visual analog scale (VAS) scores. All patients achieved union of their fracture. LTS was measured on GS radiographs of both injured and contralateral uninjured extremities.ResultsForty-two patients were included with minimum 1-year follow-up. Average age was 49 years (range 19-72). Mean measurements on injury GS radiographs were as follows: medial clear space (MCS) 4.45 mm (SD = 0.93), superior clear space (SCS) 3.46 mm (SD = 0.70), and LTS 2.33 mm (SD = 1.57, range 0-4.7 mm), with 35 (83.3%) patients having injury LTS ≤4 mm. Mean measurements on contralateral (uninjured) GS radiographs were as follows: MCS 3.39 mm (SD = 0.63), SCS 3.15 mm (SD = 0.50), and LTS 1.30 mm (SD = 1.28, range 0-4.8 mm). There was no statistically significant difference in all outcome measures based on amount of LTS (<2 mm, 2-4 mm, >4 mm).ConclusionMost patients had injury LTS ≤4 mm, although those with LTS >4 mm had excellent outcome scores. LTS measurements on normal ankles reveal a large range. LTS may be a useful adjunct in evaluating isolated Weber B ankle fractures but the 4-mm cutoff may not be entirely reliable. Further studies are required to validate LTS as a decision-making tool.Level of evidenceLevel IV, case series.
| S-EPMC10363887 | biostudies-literature
Project description:Current treatment strategy for managing Weber B ankle fractures is mainly governed by mortise congruency, malleolar alignment, deltoid ligament competence and fracture stability. While nonoperative treatment has yielded good functional outcomes in satisfactorily aligned stable injuries, a biomechanical rationale is not firmly established. Furthermore, current radiographic analysis is obscured by observer inaccuracy and beam rotation. This study aimed to utilize weightbearing CT and computational biomechanics to analyse 3D mortise displacement and contact mechanics in Weber-B ankle fractures and compare them with the uninjured contralateral side. 32 patients were included who sustained a Weber-B ankle fracture and underwent bilateral weightbearing CT imaging at injury. Segmentation into 3D models of bone was performed semi-automatically, and individualized cartilage layers were modeled based on a previously validated methodology. The 3D mortise congruency was evaluated by use of following parameters: alpha angle, fibular length, talocrural angle, medial gutter- and tibiofibular clear space- distance mapping. Contact mechanics were evaluated by the mean and maximum contact stress of the tibiotalar articulation. Statistical analysis revealed that there were no significant differences for all anatomical parameters. There was also no significant difference between the mean contact stress of the injured (2.10 ± 0.42 MPa) and uninjured side (2.10 ± 0.41 MPa), nor the maximum contact stress of the injured (7.67 ± 1.55 MPa) and uninjured (7.47 ± 1.67), respectively. Contact mechanics were unaffected in congruent Weber-B fractures. These findings support consideration of nonoperative management in such cases, given their presumably low risk for posttraumatic arthritic development in the long term. Level of Evidence: Level III; retrospective case-control study.
| S-EPMC11538441 | biostudies-literature
Project description:BackgroundEarly detection of post-traumatic cartilage damage in the ankle joint in magnetic resonance images can be difficult due to disturbances to structures usually appearing over time.PurposeTo study the articular cartilage of unilateral Weber type-B/SER-type ankle fractures shortly post-trauma using T2 relaxation time.Material and methodsFifty one fractured ankles were gathered from consecutively screened patients, compiled initially for RCT studies, and treated at Oulu University Hospital and classified as stable (n = 28) and unstable fractures (n = 23) based on external-rotation stress test: medial clear space of ≥5 mm was interpreted as unstable. A control group of healthy young individuals (n = 19) was also gathered. All ankles were imaged on average 9 (range: 1 to 25) days after injury on a 3.0T MRI unit for T2 relaxation time assessment, and the cartilage was divided into sub-regions for comparison.ResultsControl group displayed significantly higher T2 values in tibial cartilage compared to stable (six out of nine regions, p-values = .003-.043) and unstable (six out of nine regions, p-values = .001-.037) ankle fractures. No differences were detected in talar cartilage. Also, no differences were observed between stable and unstable fractures in tibial or talar cartilage.ConclusionsLower T2 relaxation times of tibial cartilage in fractured ankles suggest intact extra cellular matrix (ECM) of the cartilage. Severity of the ankle fracture, measured by ankle stability, does not seem to increase ECM degradation immediately after trauma.
| S-EPMC10540593 | biostudies-literature
Project description:BackgroundAcute ankle sprains are common and activity limiting injuries, and topical diclofenac gel has proven efficacy in alleviating pain and restoring function. This trial aimed to compare a topical natural agent, Traumeel with topical diclofenac gel (1%) in the management of acute ankle sprain.MethodsThis prospective, multicentre, randomised, blinded, active-control and non-inferiority study involved 449 physically active adults sustaining unilateral grade 1 or 2 ankle sprain within the past 24 h. Participants were randomised to receive 2 g of Traumeel ointment (T-O) (n = 152) or Traumeel gel (T-G) (n = 150) or diclofenac gel (D-G) (n = 147), administered topically to the ankle three times a day for 14 days, with 6-weeks follow up.ResultsDay 7 median percentage reductions in Visual Analogue Scale pain score were 60.6%, 71.1% and 68.9% for the T-O, T-G and D-G groups, respectively. Total pain relief was reported by 12 (8.5%), 7 (5.0%) and 8 (5.9%) participants in each group, respectively. Median improvements in Foot and Ankle Ability Measure Activities of Daily Living subscale score were 26.2, 26.2 and 25.0 points for T-O, T-G and D-G groups, respectively. Mann-Whitney effect sizes and lower bound confidence intervals demonstrated non-inferiority of Traumeel vs. diclofenac for reducing pain and functional improvement. At 6 weeks, participants reported total pain relief and normal functioning. Adverse events (n = 43) were reported by 31/447 participants (6.9%). Treatments were equally well tolerated.ConclusionsT-O and T-G decreased pain and improved joint function to the same extent as D-G in acute ankle sprain, and were well tolerated.
| S-EPMC4231442 | biostudies-literature
Project description:IntroductionSurgery is widely recognised as the treatment of choice for suprasyndesmotic ankle fractures, because of the assumption that these injuries yield instability of the ankle joint. Stability assessment of ankle fractures using weightbearing radiographs is now used regularly to guide the treatment of transsyndesmotic and infrasyndesmotic ankle fractures. Patients with a congruent ankle joint on weightbearing radiographs can be treated non-operatively with excellent results. Weightbearing radiographs are, however, rarely performed on suprasyndesmotic fractures due to the assumed unstable nature of these fractures. If weightbearing radiographs can be used to identify suprasyndesmotic fractures suitable for non-operative treatment, we may save patients from the potential burdens of surgery.Our aim is to compare the efficacy of operative and non-operative treatment of patients with suprasyndesmotic ankle fractures that reduce on weightbearing radiographs.Methods and analysisA non-inferiority randomised controlled trial involving 120 patients will be conducted. A total of 120 patients with suprasyndesmotic ankle fractures with an initial radiographic medial clear space of <7 mm will be subjected to weightbearing radiographs. If the tibio-talar joint is completely reduced, we will randomise in a 1:1 ratio to either operative treatment including reduction and fixation of the syndesmosis or non-operative treatment with an orthosis. The primary study outcome is patient-reported ankle function and symptoms as measured by the Olerud-Molander Ankle Score at 2-year follow-up. Secondary outcomes include the Manchester-Oxford Foot Questionnaire, range of motion, radiographic results and rates of adverse events.Ethics and disseminationThe Regional Committee for Medical and Health Research South East, group A (permission number: 169307), has granted ethics approval. The results of this study will provide valuable insights for developing future diagnostic and treatment strategies for a common fracture type. The findings will be shared through publication in peer-reviewed journals and presentations at conferences.Trial registration numberNCT04615650.
| S-EPMC10806705 | biostudies-literature
Project description:BackgroundUnstable ankle fractures represent a substantial burden of disease, accounting for a mean hospital stay of nine days, a mean cost of £4,491 per patient and 20,000 operations per year. There is variation in UK practice around weight-bearing instructions after operatively managed ankle fracture. Early weight-bearing may reduce reliance on health services, time off work, and improve functional outcomes. However, concerns remain about the potential for complications such as implant failure. This is the protocol of a multicentre randomised non-inferiority clinical trial of weight-bearing following operatively treated ankle fracture.MethodsAdults aged 18 years and over who have been managed operatively for ankle fracture will be assessed for eligibility. Baseline function (Olerud and Molander Ankle Score [OMAS]), health-related quality of life (EQ-5D-5L), and complications will be collected after informed consent has been obtained. A randomisation sequence has been prepared by a trial statistician to allow for 1:1 allocation to receive either instruction to weight-bear as pain allows from the point of randomisation, two weeks after the time of surgery ('early weight-bearing' group) or to not weight-bear for a further four weeks ('delayed weight -bearing' group). All other treatment will be as per the guidance of the treating clinician. Participants will be asked about their weight-bearing status weekly until four weeks post-randomisation. At four weeks post-randomisation complications will be collected. At six weeks, four months, and 12 months post-randomisation, the OMAS, EQ-5D-5L, complications, physiotherapy input, and resource use will be collected. The primary outcome measure is ankle function (OMAS) at four months post-randomisation. A minimum of 436 participants will be recruited to obtain 80% power to detect a non-inferiority margin of -6 points on the OMAS 4 months post-randomisation. A within-trial health economic evaluation will be conducted to estimate the cost-effectiveness of the treatment options.DiscussionThe results of this study will inform national guidance with regards to the most clinically and cost-effective strategy for weight-bearing after surgery for unstable ankle fractures.Trial registrationISRCTN12883981 , Registered 02 December 2019.
| S-EPMC8353856 | biostudies-literature