Surgical versus conservative interventions for treating ankle fractures in adults

Donken, C.C.M.A.; Al-Khateeb, Hesham; Verhofstad, Michael H J; Laarhoven, Cornelis J. H. M. van

doi:10.1002/14651858.cd008470.pub2

Cited by 94 publications

(104 citation statements)

References 31 publications

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“…The OMAS is one of the most commonly used outcome measures in ankle fracture research, 23,110 but has been criticised for methodological shortcomings in its development. 111 We found no published minimal clinically important differences for the OMAS and, therefore, had to develop the sample size drawing on wider literature and in consultation with clinical experts.…”

Section: Internal Validity and Methodologymentioning

confidence: 99%

“…These findings are supported by a Cochrane review that compared surgical and conservative management of ankle fractures with follow-up from 20 weeks to, on average, 7 years. 23 A randomised trial in elderly patients with a mean follow-up of 27 months also found negligible incidence beyond 3 months. 29 As published evidence of the long-term complications shows low incidence and no difference between operative and non-operative management, we did not plan to model any long-term differences in complications between ORIF and CCC.…”

Section: Lifetime Extrapolationmentioning

confidence: 98%

“…23 Only one previously published randomised controlled trial has studied older adults. Makwana et al 29 randomised 43 participants aged 66 years to ORIF or a moulded below-knee plaster cast.…”

Section: Current Management Of Ankle Fractures In Older Adultsmentioning

confidence: 99%

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The Ankle Injury Management (AIM) trial: a pragmatic, multicentre, equivalence randomised controlled trial and economic evaluation comparing close contact casting with open surgical reduction and internal fixation in the treatment of unstable ankle fractures in patients aged over 60 years

Keene

Mistry

Nam

et al. 2016

Health Technol Assess

126

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BackgroundClose contact casting (CCC) may offer an alternative to open reduction and internal fixation (ORIF) surgery for unstable ankle fractures in older adults.ObjectivesWe aimed to (1) determine if CCC for unstable ankle fractures in adults aged over 60 years resulted in equivalent clinical outcome compared with ORIF, (2) estimate cost-effectiveness to the NHS and society and (3) explore participant experiences.DesignA pragmatic, multicentre, equivalence randomised controlled trial incorporating health economic evaluation and qualitative study.SettingTrauma and orthopaedic departments of 24 NHS hospitals.ParticipantsAdults aged over 60 years with unstable ankle fracture. Those with serious limb or concomitant disease or substantial cognitive impairment were excluded.InterventionsCCC was conducted under anaesthetic in theatre by surgeons who attended training. ORIF was as per local practice. Participants were randomised in 1 : 1 allocation via remote telephone randomisation. Sequence generation was by random block size, with stratification by centre and fracture pattern.Main outcome measuresFollow-up was conducted at 6 weeks and, by blinded outcome assessors, at 6 months after randomisation. The primary outcome was the Olerud–Molander Ankle Score (OMAS), a patient-reported assessment of ankle function, at 6 months. Secondary outcomes were quality of life (as measured by the European Quality of Life 5-Dimensions, Short Form questionnaire-12 items), pain, ankle range of motion and mobility (as measured by the timed up and go test), patient satisfaction and radiological measures. In accordance with equivalence trial US Food and Drug Administration guidance, primary analysis was per protocol.ResultsWe recruited 620 participants, 95 from the pilot and 525 from the multicentre phase, between June 2010 and November 2013. The majority of participants, 579 out of 620 (93%), received the allocated treatment; 52 out of 275 (19%) who received CCC later converted to ORIF because of loss of fracture reduction. CCC resulted in equivalent ankle function compared with ORIF at 6 months {OMAS 64.5 points [standard deviation (SD) 22.4 points] vs. OMAS 66.0 points (SD 21.1 points); mean difference –0.65 points, 95% confidence interval (CI) –3.98 to 2.68 points; standardised effect size –0.04, 95% CI –0.23 to 0.15}. There were no differences in quality of life, ankle motion, pain, mobility and patient satisfaction. Infection and/or wound problems were more common with ORIF [29/298 (10%) vs. 4/275 (1%)], as were additional operating theatre procedures [17/298 (6%) vs. 3/275 (1%)]. Malunion was more common with CCC [38/249 (15%) vs. 8/274 (3%);p < 0.001]. Malleolar non-union was lower in the ORIF group [lateral: 0/274 (0%) vs. 8/248 (3%);p = 0.002; medial: 3/274 (1%) vs. 18/248 (7%);p < 0.001]. During the trial, CCC showed modest mean cost savings [NHS mean difference –£644 (95% CI –£1390 to £76); society mean difference –£683 (95% CI –£1851 to £536)]. Estimates showed some imprecision. Incremental quality-adjusted life-years following CCC were no different from ORIF. Over common willingness-to-pay thresholds, the probability that CCC was cost-effective was very high (> 95% from NHS perspective and 85% from societal perspective). Experiences of treatments were similar; both groups endured the impact of fracture, uncertainty regarding future function and the need for further interventions.LimitationsAssessors at 6 weeks were necessarily not blinded. The learning-effect analysis was inconclusive because of limited CCC applications per surgeon.ConclusionsCCC provides a clinically equivalent outcome to ORIF at reduced cost to the NHS and to society at 6 months.Future workLonger-term follow-up of trial participants is under way to address concerns over potential later complications or additional procedures and their potential to impact on ankle function. Further study of the patient factors, radiological fracture patterns and outcomes, treatment responses and prognosis would also contribute to understanding the treatment pathway.Trial registrationCurrent Controlled Trials ISRCTN04180738.FundingThe National Institute for Health Research Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 20, No. 75. See the NIHR Journals Library website for further project information. This report was developed in association with the National Institute for Health Research Oxford Biomedical Research Unit funding scheme. The pilot phase was funded by the AO Research Foundation.

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Section: Internal Validity and Methodologymentioning

confidence: 99%

Section: Lifetime Extrapolationmentioning

confidence: 98%

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The Ankle Injury Management (AIM) trial: a pragmatic, multicentre, equivalence randomised controlled trial and economic evaluation comparing close contact casting with open surgical reduction and internal fixation in the treatment of unstable ankle fractures in patients aged over 60 years

Keene

Mistry

Nam

et al. 2016

Health Technol Assess

126

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“…Ankle fractures with a posterior malleolar fragment are known to have a worse prognosis than malleolar fractures without posterior fragment [1,3]. Posterior malleolar fractures are often caused by pronation or supination external rotation trauma, also causing fracture of the lateral and medial malleolus, as described by the Lauge-Hansen classification [4].…”

Section: Introductionmentioning

confidence: 99%

Longterm outcome of 886 posterior malleolar fractures: A systematic review of the literature

Veltman¹,

Halma

Gast

2016

Foot and Ankle Surgery

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“…Em relação ao grupamento muscular do tríceps sural (TS), esta abordagem tem sido bem empregada tendo em vista sua importância funcional nas atividades de vida diária e nos desempenhos esportivos [3][4][5] , assim como na incidência de traumas acometidos a região do tornozelo [6][7] . Dentre outros fatores, o TS contribui na manutenção da postura ereta, nas várias fases da marcha 8 , na propulsão em movimentos explosivos como o salto e a corrida 4,[8][9] .…”

Section: Introductionunclassified

Influência de posições do joelho no torque e atividade mioelétrica do tríceps sural na flexão plantar isométrica máxima

Baptista

Nascimento

Nardes

et al. 2014

Rev. bras. educ. fís. esporte

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Surgical versus conservative interventions for treating ankle fractures in adults

Cited by 94 publications

References 31 publications

The Ankle Injury Management (AIM) trial: a pragmatic, multicentre, equivalence randomised controlled trial and economic evaluation comparing close contact casting with open surgical reduction and internal fixation in the treatment of unstable ankle fractures in patients aged over 60 years

The Ankle Injury Management (AIM) trial: a pragmatic, multicentre, equivalence randomised controlled trial and economic evaluation comparing close contact casting with open surgical reduction and internal fixation in the treatment of unstable ankle fractures in patients aged over 60 years

Longterm outcome of 886 posterior malleolar fractures: A systematic review of the literature

Influência de posições do joelho no torque e atividade mioelétrica do tríceps sural na flexão plantar isométrica máxima

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