Operative Versus Nonoperative Treatment of Unstable Lateral Malleolar Fractures

Sanders, David; Tieszer, Christina; Corbett, Bradley A.

doi:10.1097/bot.0b013e3182460837

Cited by 133 publications

(126 citation statements)

References 22 publications

(25 reference statements)

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“…78 This is, however, just one domain of health-related quality of life. Utility at each time point was not reported and thus it is not possible to explain the nature of the (imprecise) QALY difference in the Slobogean et al analysis.…”

Section: Health Economic Evaluationmentioning

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: Health Economic Evaluationmentioning

confidence: 99%

“…78 The study included 81 participants who had an isolated, undisplaced, unstable, type B fracture of the distal fibula. Participants were younger than those in the AIM trial, aged, on average, 41 years.…”

mentioning

confidence: 99%

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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“…19 Sanders et al in 2012 conducted a randomized multicenter trial to compare clinical and functional outcomes after operative and non-operative treatment of undisplaced, unstable, isolated fibula fractures and concluded that patients managed operatively had equivalent functional outcomes compared with non-operative treatment; however, the risk of displacement and problems with union was substantially lower in patients managed with surgery. 20 Berkes et al in 2013 examined the impact of articular surface congruity on the functional outcomes of operative treatment of supination external rotation IV ankle fractures. Post-operative CT scans were used to assess ankle joint congruity.…”

Section: Inferencementioning

confidence: 99%

Functional Outcome Following Operative Treatment of Ankle Fractures

D'Almeida¹,

Thomas²,

Devasia³

et al. 2015

jemds

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“…Conservative care of non-displaced fractures usually results in satisfactory outcomes for patients, and has lower risk profiles than operative treatment [6]. However, non-unions do occur and several ways have been documented on how to treat them [3].…”

Section: Discussionmentioning

confidence: 99%

“…When a fibula is fractured, 75-85% of the time it occurs concomitantly with a tibia fracture, often due to a rotational injury [2][3][4][5]. Stability of the fracture is assessed and when it is stable and non-displaced, conservative treatment is recommended, with satisfactory results [2,6]. This includes 6-8 weeks of protected or non-weight bearing in an immobilizing boot or below knee cast.…”

Section: Introductionmentioning

confidence: 99%

Danis-Weber a Non-Union in a Teenager: A Case Report and Review of Literature

Sundling¹

2017

MOJOR

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Case: This case focuses on the occurrence and treatment of a non-union of a Danis-Weber A fracture in a teenage girl. After 5 months of protected weight bearing and the diagnosis of a non-union, a bone stimulator was added to the treatment plan. Two months later without noted healing, the patient was taken to the operating room for open reduction internal fixation with both allograft and autograft.

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Operative Versus Nonoperative Treatment of Unstable Lateral Malleolar Fractures

Abstract: Patients managed operatively had equivalent functional outcomes compared with nonoperative treatment; however, the risk of displacement and problems with union was substantially lower in patients managed with surgery.

Cited by 133 publications

References 22 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

Functional Outcome Following Operative Treatment of Ankle Fractures

Danis-Weber a Non-Union in a Teenager: A Case Report and Review of Literature

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