Comparison of close contact cast (CCC) technique to open surgical reduction and internal fixation (ORIF) in the treatment of unstable ankle fractures in patients over 60 years

Conditions

Displaced unstable fracture of the ankle Injury, Occupational Diseases, Poisoning Fracture of lower leg, including ankle

David J. Keene, Karan Vadher, Keith Willett, Dipesh Mistry, Matthew L. Costa et al. (7 authors)

BMJ Open2019-07-0112 citations

10.1136/bmjopen-2019-029813

Close Contact Casting vs Surgery for Initial Treatment of Unstable Ankle Fractures in Older Adults

Keith Willett, David J. Keene, Dipesh Mistry, Julian Nam, Elizabeth Tutton et al. (14 authors)

JAMA2016-10-11125 citations

10.1001/jama.2016.14719

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

2016-10-0174 citations

10.3310/hta20750

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 K, Keene DJ, Morgan L, Gray B, Handley R, Chesser T, Pallister I, Tutton E, Knox C, Lall R, Briggs A, Lamb SE.

2014-03-1212 citations

10.1186/1471-2474-15-79

Interventions

Participants will be randomised to receive ORIF or CCC. Standard care group - ORIF: Specific implant selection will not be fixed by the trial but surgeons must comply

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Men or women aged over 60 years 2. Isolated displaced unstable ankle fracture 3. Ambulatory prior to the injury - in any capacity 4. Capable of giving informed consent 5. Capable of adhering to post-operative instructions 6. Resident within the catchment area of a recruiting hospital - can attend for 6 month follow up

Exclusion criteria

Exclusion criteria: 1. Established critical limb ischaemia 2. Insulin dependent diabetes 3. Active leg ulceration 4. Open fractures 5. Serious contaminant disease - metastatic disease or terminal illness 6. Clinically substantial degenerative or inflammatory arthritis 7. Unfit for anaesthetic 8. Unable to give informed consent - cognitive impairment demonstrated by Mini-Mental State Exam (MMSE) of under 16/30 9. Patient unwilling to give informed consent

Design outcomes

Primary

Measure	Time frame
Patient reported functional outcome measure based on the Olerud and Molander Ankle Score. This scores 10 separate activities: Pain, stiffness, swelling, jumping, supports, activities of daily living, running, stair climbing and squatting with a range of 0 to 100. Some of the items may not be relevant or sensitive to change in the older patient, including running, squatting and jumping so it will be analysed at each individual item level. If there is evidence of a significant floor effect these items will be excluded from the final analysis and be summarised as a modified Olerud and Molander Score. All primary outcomes will be assessed at baseline, 6 weeks and 6 months.	—

Measure

Time frame

Patient reported functional outcome measure based on the Olerud and Molander Ankle Score. This scores 10 separate activities: Pain, stiffness, swelling, jumping, supports, activities of daily living, running, stair climbing and squatting with a range of 0 to 100. Some of the items may not be relevant or sensitive to change in the older patient, including running, squatting and jumping so it will be analysed at each individual item level. If there is evidence of a significant floor effect these items will be excluded from the final analysis and be summarised as a modified Olerud and Molander Score. All primary outcomes will be assessed at baseline, 6 weeks and 6 months.

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Secondary

Measure	Time frame
10 days post ORIF: 1. ASEPSIS wound score - to assess soft tissue complications including wound edge necrosis and infection with range of 0 to 70 (under 10 = normal healing) 6 weeks: 1. Iowa ankle score: ankle range of movement component - goniometer measurement in flexion, extension, inversion and eversion 2. Radiological measurements of fracture and ankle joint congruence 3. Euroqol EQ-5D and SF-12® Health Survey - Quality of life/utilities measure 4. Patient satisfaction measure - tailored questionnaire 5. Qualitative assessment by semi-structured interview of a 20 participant sample each group 6 months: 1. Iowa ankle score - ankle range of movement component: goniometer measurement in flexion, extension, inversion and eversion 2. Radiological measurements of fracture and ankle joint congruence 3. Euroqol EQ-5D and SF-12® Health Survey - Quality of life/utilities measure 4. Patient satisfaction measure - tailored questionnaire 5. Timed 'Get up and Go' test 6. Cost-effectiveness will be measured by an economic analysis conducted along side the trial and will include modelling to extrapolate beyond trial data to give cost per Quality-Adjusted Life Years (QALY) estimates. The analysis will incorporate the elements of: 6.1. Duration of inpatient hospital stay 6.2. Theatre time/implant costs 6.3. Fracture Clinic visits 6.4. Additional treatment costs and 6.5. Social dependency/support change at 6 months	—

Measure

Time frame

10 days post ORIF: 1. ASEPSIS wound score - to assess soft tissue complications including wound edge necrosis and infection with range of 0 to 70 (under 10 = normal healing) 6 weeks: 1. Iowa ankle score: ankle range of movement component - goniometer measurement in flexion, extension, inversion and eversion 2. Radiological measurements of fracture and ankle joint congruence 3. Euroqol EQ-5D and SF-12® Health Survey - Quality of life/utilities measure 4. Patient satisfaction measure - tailored questionnaire 5. Qualitative assessment by semi-structured interview of a 20 participant sample each group 6 months: 1. Iowa ankle score - ankle range of movement component: goniometer measurement in flexion, extension, inversion and eversion 2. Radiological measurements of fracture and ankle joint congruence 3. Euroqol EQ-5D and SF-12® Health Survey - Quality of life/utilities measure 4. Patient satisfaction measure - tailored questionnaire 5. Timed 'Get up and Go' test 6. Cost-effectiveness will be measured by an economic analysis conducted along side the trial and will include modelling to extrapolate beyond trial data to give cost per Quality-Adjusted Life Years (QALY) estimates. The analysis will incorporate the elements of: 6.1. Duration of inpatient hospital stay 6.2. Theatre time/implant costs 6.3. Fracture Clinic visits 6.4. Additional treatment costs and 6.5. Social dependency/support change at 6 months

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Countries

United Kingdom

Outcome results

None listed