NIHR Signal New casting technique is an option for older people with ankle fracture

Published on 18 April 2017

A new casting technique called “close contact casting” is an alternative to surgery for older people with ankle fracture. Ankle function at six months was similar in people who had casting and those who had surgery but there are some disadvantages to both that patients and surgeons could consider.

This UK-based NIHR trial recruited 620 people aged over 60 years with an unstable ankle fracture that would usually be fixed with surgery.

People who had a cast were less likely to have infections or wound problems than those who had surgery. However, one in five people in the casting group had to undergo surgery later because their fracture was not healing in the right position.

Close contact casting was around £650 cheaper than surgery, and was very likely to be cost effective at current NHS thresholds.

Participants are being followed up for another year and a half to assess longer term outcomes such as arthritis and this will further help in balancing the benefits and harms of these options.

New casting technique is an option for older people with ankle fracture

Why was this study needed?

People who fracture their ankle are treated either conservatively by stabilising the joint with a plaster cast or surgically to align the broken bones and fix them in place with metal screws or plates. If the fracture is ‘unstable’ – that is, the broken ends of the bone are no longer aligned – surgery to fix the boned in place with a metal plate and screws is currently the preferred treatment.

In older people, this surgery is associated with an increased risk of complications such as infection and wound problems. But using a cast doesn’t guarantee that the bones will heal in the correct alignment and it may be linked to plaster sores. In addition, it is not clear whether surgery or close contact casting is better in the long term.

The new casting technique is performed under anaesthetic. It uses less lining and padding than traditional casting methods, so is thought to be better at stabilising the fracture and may be less likely to damage the skin. The research was designed to provide more certainty for patients and orthopaedic surgeons.

What did this study do?

The Ankle Injury Management (AIM) randomised controlled trial recruited adults aged over 60 years from 24 hospitals in the UK. Participants had an unstable ankle fracture and would normally be offered surgery.

The 311 people randomly assigned to the casting group underwent close contact casting in theatre by an orthopaedic surgeon who had been specially trained in the technique. If the fracture did not appear to be healing in the correct alignment during the first three weeks after treatment, the person would then undergo surgery.

The 309 people in the surgery group had open reduction and internal fixation surgery by an orthopaedic surgeon.

Outcomes were assessed at six months after treatment using a validated patient-reported assessment of ankle function: the Olerud-Molander Ankle Score (OMAS), a 0 to 100 scale where higher scores indicate better ankle function. However, the researchers say that six months may be too early for all complications to appear.

What did it find?

  • At six months, ankle function was similar in the casting group (64.5 points on OMAS) and the surgery group (66.0 points; mean difference −0.65 points, 95% confidence interval −3.98 to 2.68 points).
  • One in five people who had casting had to undergo surgery later because the fracture was not healing in the right position. In addition, X-rays at six months showed that misaligned healing was more common in the casting group than in the surgery group (38/249 [15%] vs 8/274 [3%]).
  • Infections or wound problems were more common in the surgery group than in the casting group (29/298 people [10%] vs 4/275 [1%]).
  • At six months, the mean cost to the NHS was £6050 for casting, compared with £6694 for surgery (mean difference −£644, 95% confidence interval −£1390 to £76). The mean cost to society was £7320 for casting, compared with £8003 for surgery (mean difference −£683, 95% confidence interval −£1851 to £536).
  • The probability that casting was cost effective at common willingness-to-pay thresholds was very high (>95% for NHS and 85% for society).

What does current guidance say on this issue?

The 2016 British Orthopaedic Association Standard for Trauma on management of ankle fractures recommends early surgery (on the day or day after injury) for the majority of people under 60 years who have unstable ankle fracture. Surgery should aim to realign and stabilise the ankle. It states that close contact casts are an option in people over 60 years, if bone alignment can be maintained.

The 2016 NICE guideline on non-complex fractures recommends surgery for ankle fractures. It does not make any recommendations on the use of close contact casting.

What are the implications?

This study suggests that many unstable ankle fractures in older people could be initially treated with close contact casting. This conservative approach does not compromise function compared with surgery and would be cheaper for the NHS. However, implementing the technique in UK hospitals would require some cost in terms of training healthcare staff and closer follow-up of patients after treatment.

The actual levels of ankle function were quite poor for both treatment groups, suggesting a considerable level of impairment irrespective of treatment in older people who fracture their ankle. More focus may be needed on recovery and rehabilitation of older people who fracture their ankle.

Citation and Funding

Keene DJ, Mistry D, Nam J, et al. 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. Health Technol Assess. 2016;20(75):1-158.

This project was funded by the National Institute for Health Research Health Technology Assessment Programme (project number 07/37/61).

Bibliography

British Orthopaedic Association Standards for Trauma. Management of ankle fractures. BOAST 12. London: British Orthopaedic Association Standards for Trauma; 2016.

Donken CC, Al-Khateeb H, Verhofstad MH, et al. Surgical versus conservative interventions for treating ankle fractures in adults. Cochrane Database Syst Rev. 2012;(8):CD008470.

NHS Choices. Broken ankle. London: Department of Health; 2015.

NICE. Fractures (non-complex): assessment and management. NG38. London: National Institute for Health and Care Excellence; 2016.

NIHR Dissemination Centre. Alternatives to open surgery. London: National Institute for Health Research Dissemination Centre; 2016.

Sanders DW. Close contact casting vs surgery for unstable ankle fractures. JAMA. 2016;316(14):1451-52.

Willett K, Keene DJ, Mistry D, et al. Close contact casting vs surgery for initial treatment of unstable ankle fractures in older adults: a randomized clinical trial. JAMA. 2016;316(14):1455-63.

Why was this study needed?

People who fracture their ankle are treated either conservatively by stabilising the joint with a plaster cast or surgically to align the broken bones and fix them in place with metal screws or plates. If the fracture is ‘unstable’ – that is, the broken ends of the bone are no longer aligned – surgery to fix the boned in place with a metal plate and screws is currently the preferred treatment.

In older people, this surgery is associated with an increased risk of complications such as infection and wound problems. But using a cast doesn’t guarantee that the bones will heal in the correct alignment and it may be linked to plaster sores. In addition, it is not clear whether surgery or close contact casting is better in the long term.

The new casting technique is performed under anaesthetic. It uses less lining and padding than traditional casting methods, so is thought to be better at stabilising the fracture and may be less likely to damage the skin. The research was designed to provide more certainty for patients and orthopaedic surgeons.

What did this study do?

The Ankle Injury Management (AIM) randomised controlled trial recruited adults aged over 60 years from 24 hospitals in the UK. Participants had an unstable ankle fracture and would normally be offered surgery.

The 311 people randomly assigned to the casting group underwent close contact casting in theatre by an orthopaedic surgeon who had been specially trained in the technique. If the fracture did not appear to be healing in the correct alignment during the first three weeks after treatment, the person would then undergo surgery.

The 309 people in the surgery group had open reduction and internal fixation surgery by an orthopaedic surgeon.

Outcomes were assessed at six months after treatment using a validated patient-reported assessment of ankle function: the Olerud-Molander Ankle Score (OMAS), a 0 to 100 scale where higher scores indicate better ankle function. However, the researchers say that six months may be too early for all complications to appear.

What did it find?

  • At six months, ankle function was similar in the casting group (64.5 points on OMAS) and the surgery group (66.0 points; mean difference −0.65 points, 95% confidence interval −3.98 to 2.68 points).
  • One in five people who had casting had to undergo surgery later because the fracture was not healing in the right position. In addition, X-rays at six months showed that misaligned healing was more common in the casting group than in the surgery group (38/249 [15%] vs 8/274 [3%]).
  • Infections or wound problems were more common in the surgery group than in the casting group (29/298 people [10%] vs 4/275 [1%]).
  • At six months, the mean cost to the NHS was £6050 for casting, compared with £6694 for surgery (mean difference −£644, 95% confidence interval −£1390 to £76). The mean cost to society was £7320 for casting, compared with £8003 for surgery (mean difference −£683, 95% confidence interval −£1851 to £536).
  • The probability that casting was cost effective at common willingness-to-pay thresholds was very high (>95% for NHS and 85% for society).

What does current guidance say on this issue?

The 2016 British Orthopaedic Association Standard for Trauma on management of ankle fractures recommends early surgery (on the day or day after injury) for the majority of people under 60 years who have unstable ankle fracture. Surgery should aim to realign and stabilise the ankle. It states that close contact casts are an option in people over 60 years, if bone alignment can be maintained.

The 2016 NICE guideline on non-complex fractures recommends surgery for ankle fractures. It does not make any recommendations on the use of close contact casting.

What are the implications?

This study suggests that many unstable ankle fractures in older people could be initially treated with close contact casting. This conservative approach does not compromise function compared with surgery and would be cheaper for the NHS. However, implementing the technique in UK hospitals would require some cost in terms of training healthcare staff and closer follow-up of patients after treatment.

The actual levels of ankle function were quite poor for both treatment groups, suggesting a considerable level of impairment irrespective of treatment in older people who fracture their ankle. More focus may be needed on recovery and rehabilitation of older people who fracture their ankle.

Citation and Funding

Keene DJ, Mistry D, Nam J, et al. 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. Health Technol Assess. 2016;20(75):1-158.

This project was funded by the National Institute for Health Research Health Technology Assessment Programme (project number 07/37/61).

Bibliography

British Orthopaedic Association Standards for Trauma. Management of ankle fractures. BOAST 12. London: British Orthopaedic Association Standards for Trauma; 2016.

Donken CC, Al-Khateeb H, Verhofstad MH, et al. Surgical versus conservative interventions for treating ankle fractures in adults. Cochrane Database Syst Rev. 2012;(8):CD008470.

NHS Choices. Broken ankle. London: Department of Health; 2015.

NICE. Fractures (non-complex): assessment and management. NG38. London: National Institute for Health and Care Excellence; 2016.

NIHR Dissemination Centre. Alternatives to open surgery. London: National Institute for Health Research Dissemination Centre; 2016.

Sanders DW. Close contact casting vs surgery for unstable ankle fractures. JAMA. 2016;316(14):1451-52.

Willett K, Keene DJ, Mistry D, et al. Close contact casting vs surgery for initial treatment of unstable ankle fractures in older adults: a randomized clinical trial. JAMA. 2016;316(14):1455-63.

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

Published on 1 October 2016

Keene DJ, Mistry D, Nam J, Tutton L, Handley R, Morgan L, Roberts E, Gray B, Briggs A, Lall R, Chesser TJS, Pallister I, Lamb SE, Willett K.

Health Technology Assessment Volume 20 Issue 75 , 2016

Background Close contact casting (CCC) may offer an alternative to open reduction and internal fixation (ORIF) surgery for unstable ankle fractures in older adults. Objectives We 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. Design A pragmatic, multicentre, equivalence randomised controlled trial incorporating health economic evaluation and qualitative study. Setting Trauma and orthopaedic departments of 24 NHS hospitals. Participants Adults aged over 60 years with unstable ankle fracture. Those with serious limb or concomitant disease or substantial cognitive impairment were excluded. Interventions CCC 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 measures Follow-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. Results We 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. Limitations Assessors at 6 weeks were necessarily not blinded. The learning-effect analysis was inconclusive because of limited CCC applications per surgeon. Conclusions CCC provides a clinically equivalent outcome to ORIF at reduced cost to the NHS and to society at 6 months. Future work Longer-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. Funding The National Institute for Health Research Health Technology Assessment programme and will be published in full in Health 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.

The main type of surgery used to treat unstable ankle fractures is open reduction and internal fixation. This technique involves opening the ankle to reposition the broken ends of bone (that is, reduce the deformity). The realigned bone fragments are then fixed in place with metal plates or screws, or both.

Close contact casting is a new technique for applying a plaster cast to a broken ankle. It uses less padding than traditional casting approaches. Pressure is applied during moulding of the cast to hold the joint tightly in place so that the bone heals in the correct alignment. The cast is applied in the operating theatre, with the patient under spinal or general anaesthetic.

Expert commentary

Conventional belief that some broken bones that are out of place should be re-aligned and fixed with surgery is being challenged in many areas. The ankle is one such area, where surgery carries risks, particularly in older people. In addition, metal-ware used for fixing ankle fractures can cause on-going irritation for some patients. This study has clearly shown that using a special plaster cast technique after re-aligning an ankle fracture yields as good a result as surgery, whilst avoiding the risks of surgery. It is time for surgeons to master this alternative skill of close contact casting!

Amar Rangan, Professor of Orthopaedic Surgery, Orthopaedic Research Lead, Royal College of Surgeons of England

Expert commentary

From a physiotherapy perspective, it will be important to be aware of these findings, and the casting technique used, to facilitate rehabilitation of older patients who have received this treatment. Regardless of the initial treatment used to hold the ankle in position, patients report worse ankle function at 6 months compared to before the injury. The need to optimise recovery for older people after ankle fracture forms the basis of our on-going research, which aims to develop and test new ways of delivering physiotherapy.

Dr David Keene, NIHR Postdoctoral Research Fellow, NDORMS Research Fellow in Trauma Rehabilitation

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  •   Musculo-skeletal disorders, Orthopaedics, Surgery