Ankle Injury Management (AIM): design of a pragmatic multi-centre equivalence randomised controlled trial comparing Close Contact Casting (CCC) to Open surgical Reduction and Internal Fixation (ORIF) in the treatment of unstable ankle fractures in patients over 60 years

Willett, Keith; Keene, David; Morgan, Lesley; Gray, Bridget; Handley, Robert; Chesser, Tim; Pallister, Ian; Tutton, Elizabeth; Knox, Christopher; Lall, Ranjit; Briggs, Andrew; Lamb, Sarah E

doi:10.1186/1471-2474-15-79

Cited by 14 publications

(7 citation statements)

References 44 publications

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“…There are a number of studies published on functional recovery following ankle fracture fixation. 2,8,10,11,19,24 However, there is minimal evidence of the long-term outcomes. Our study has identified that there will be a permanent significant reduction in the functional outcome following ankle fracture fixation over time.…”

Section: Discussionmentioning

confidence: 99%

“…In the Ankle Injury Management (AIM) trial, the authors reported a reduction in OMAS at 6 weeks and 6 months for patients aged >65 sustaining ankle fracture. 24 Nilsson et al 16 showed that patients aged >65 years with ankle fracture required at least 1 year to achieve similar functionality to the control group without a fracture. Egol et al 8 reported a significantly better outcome in patients aged <40 years in comparison with patients aged >40 years at the 1-year follow-up, but this was not shown by Lash et al 11 (2 years) or Belcher et al 2 (8-24 months).…”

Section: Discussionmentioning

confidence: 99%

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Patient Outcomes Following Ankle Fracture Fixation

et al. 2021

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Background: Several studies have reported on potential negative predictive factors of functional outcomes after ankle fracture fixation. However, there is minimal patient-reported data on long-term outcomes. This study aimed to evaluate potential risk factors leading to a poor patient-reported functional outcome at 2 and 5 years following ankle fracture fixation. Methods: We conducted a prospective cohort study over a 5-year period on patients undergoing open reduction and internal fixation for unstable ankle fractures. Patient demographics, medical comorbidities, fracture pattern, and fixation quality were recorded and analyzed. Patients were followed up at 2 and 5 years. Data collected include the Olerud-Molander Ankle Score (OMAS), Lower Extremity Functional Scale (LEFS), ongoing issues, and the need for further intervention. A P value <.05 was considered statistically significant. Results: Out of 180 patients, follow-up data were available for 82 (46%) patients at 2 years and 94 (52%) patients at 5 years. At 2 years, age ≥60 years was a predictor of worse LEFS, while a body mass index ≥30 was a predictor of worse OMAS. Severely deformed ankle at presentation showed worse OMAS and LEFS score. However, these predictive factors were not significant at 5 years. An anatomically reduced ankle fracture fixation was more likely to have a better functional outcome at the 2- and 5-year follow-ups. A reduction in OMAS at 2 years was predictive of possible ongoing issues following surgery, which in turn increased the odds of worsening OMAS at 5 years. Conclusion: Achieving adequate fracture reduction during fixation is crucial for better ankle functional recovery postinjury. In this cohort, we found that patients who undergo ankle fracture fixation will have an ongoing negative impact on their functional and physical capacity at both 2 and 5 years postoperatively. Appropriate patient counseling is necessary to prepare them for the expected functional outcomes. Level of Evidence: Level II, prognostic.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Patient Outcomes Following Ankle Fracture Fixation

et al. 2021

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“…As a result, the cast must be replaced or adjusted and the condition of soft tissue must be observed regularly 11 . When facing severely unstable ankle fractures, especially those with talus dislocation or subluxation, even a good cast can hardly guarantee the maintenance of reduction 12 .…”

Section: Discussionmentioning

confidence: 99%

Temporarily double-pin external fixator fixation following unstable ankle fracture

Yuan¹,

Lü²,

Kou³

et al. 2021

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This study designed a new type of double-pin external fixator for temporary fixation of unstable ankle fractures, and the safety and effectiveness of this fixation method were explored. Cases were included in patients with ankle fractures treated in the Department of Traumatology and Orthopedics at Peking University People's Hospital from February 2016 to February 2020. Two groups of cases were obtained (cast group, n=19; double-pin external fixator group, n=21). All cases received the same postoperative care, and the VAS score before and after temporary fixation, the maintenance of fracture reduction, the complications of temporary fixation and the interval time were recorded. All patients completed follow-ups. There were 4 cases and 0 cases of complications in the cast and double-pin external fixator groups respectively. 6 cases and 1 case each had a loss of reduction in the cast and double-pin external fixator groups respectively. There was no difference in interval time for final open reduction with internal fixation between the two groups. The post-fixation VAS score of the double-pin external fixator group was significantly lower than that of the cast group. This technique is a simple, safe, and effective treatment for the temporary reduction of unstable ankle fractures with double-pin external fixator which can relieve patients' pain, effectively maintain the length of the lateral malleolus, and create good soft tissue conditions for elective surgery under the state of grasping the indications strictly.

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“…In developed countries, unstable ankle fractures typically undergo internal fixation surgery to restore normal anatomy 10. Below-knee casts are also used in older adults as they have greater risks from surgery than younger people 11. The AIM trial showed surgery and close contact casting for managing unstable ankle fractures in older adults had equivalence in functional outcomes 9.…”

Section: Introductionmentioning

confidence: 99%

Progressive functional exercise versus best practice advice for adults aged 50 years or over after ankle fracture: protocol for a pilot randomised controlled trial in the UK - the Ankle Fracture Treatment: Enhancing Rehabilitation (AFTER) study

et al. 2019

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IntroductionAnkle fractures result in significant morbidity in adults, with prognosis worsening with increasing age. Previous trials have not found evidence supporting supervised physiotherapy sessions, but these studies have not focused on older adults or tailored the exercise interventions to the complex needs of this patient group. The Ankle Fracture Treatment: Enhancing Rehabilitation study is a pilot randomised controlled trial to assess feasibility of a later definitive trial comparing best-practice advice with progressive functional exercise for adults aged 50 years and over after ankle fracture.The main objectives are to assess: (i) patient engagement with the trial, measured by the participation rate of those eligible; (ii) establish whether the interventions are acceptable to participants and therapists, assessed by intervention adherence levels, participant interviews and a therapist focus group; (iii) participant retention in the trial, measured by the proportion of participants providing outcome data at 6 months; (iv) acceptability of measuring outcomes at 3 and 6 month follow-up.Methods and analysisA multicentre pilot randomised controlled trial with an embedded qualitative study. At least 48 patients aged 50 years and over with an ankle fracture requiring surgical management, or non-operative management by immobilisation for at least 4 weeks, will be recruited from a minimum of three National Health Service hospitals in the UK. Participants will be allocated 1:1 via a central web-based randomisation system to: (i) best-practice advice (one session of face-to-face self-management advice delivered by a physiotherapist and up to two optional additional sessions) or (ii) progressive functional exercise (up to six sessions of individual face-to-face physiotherapy). An embedded qualitative study will include one-to-one interviews with up to 20 participants and a therapist focus group.Ethics and disseminationHampshire B Research Ethics Committee (18/SC/0281) gave approval on 2nd July 2018.Trial registration number ISRCTN16612336

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Ankle Injury Management (AIM): design of a pragmatic multi-centre equivalence randomised controlled trial comparing Close Contact Casting (CCC) to Open surgical Reduction and Internal Fixation (ORIF) in the treatment of unstable ankle fractures in patients over 60 years

Cited by 14 publications

References 44 publications

Patient Outcomes Following Ankle Fracture Fixation

Patient Outcomes Following Ankle Fracture Fixation

Temporarily double-pin external fixator fixation following unstable ankle fracture

Progressive functional exercise versus best practice advice for adults aged 50 years or over after ankle fracture: protocol for a pilot randomised controlled trial in the UK - the Ankle Fracture Treatment: Enhancing Rehabilitation (AFTER) study

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