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| [ Print-friendly version ] |
| 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 |
| ISRCTN | ISRCTN04180738 |
| ClinicalTrials.gov identifier | |
| Public title | 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 |
| Scientific title | 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: a pragmatic randomised controlled equivalence study |
| Acronym | AIM (Ankle Injury Management) |
| Serial number at source | HTA 07/37/61 |
| Study hypothesis |
Primary research objective
To determine if the application of the close contact casting technique (CCC) for displaced ankle fractures in older adults results in an equivalent outcome compared to the standard care of open surgical internal fixation (ORIF) in terms of function, complications, quality of life and patient satisfaction with treatment. Secondary research objective An economic evaluation will run in parallel to the trial and will consider the costs of the two treatments to (i) the NHS, and (ii) the broader societal perspective including to the individual and their family. |
| Ethics approval |
Oxfordshire Research Ethics Committee A (ref: C03.071)
Original approval: 03/09/2003 Substantial amendment approval: 18/08/2008 |
| Study design | Multi-centre pragmatic individually randomised controlled equivalence study |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Displaced unstable fracture of the ankle |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 01/10/2009 |
| Anticipated end date | 01/10/2014 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 620 |
| 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 with the (universally used) implant designs and concept of ankle fracture fragment reduction and fixation techniques. These specifications recognise historically proven concepts for successful internal fixation - AO Principles of Fracture Management . Intervention group - CCC Standardisation of the casting materials, cast design and application, and moulding technique will exist by surgeon instruction and information documentation. The method of closed fracture manipulative reduction of deformity will be left to individual surgeons and this falls within the common contemporary skills set of senior surgical trainees and consultants. All cases will conform to the NHS standard of being performed under consultant supervision and rehabilitation guidance will be the same for both treatment groups once bone healing has been confirmed as suitable to commence weight-bearing. |
| Primary outcome measure(s) |
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. |
| Secondary outcome measure(s) |
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 |
| Sources of funding | NIHR Health Technology Assessment Programme - HTA (UK) |
| Trial website | |
| Publications | |
| Contact name | Prof Keith Willett |
| Address |
Kadoorie Centre
John Radcliffe Hospital |
| City/town | Oxford |
| Zip/Postcode | OX3 9DU |
| Country | United Kingdom |
| Sponsor | University of Oxford (UK) |
| Address |
Clinical Trials and Research Governance
Manor House John Radcliffe Hospital Headington |
| City/town | Oxford |
| Zip/Postcode | OX3 9DZ |
| Country | United Kingdom |
| Sponsor website: | http://www.ox.ac.uk |
| Date applied | 29/04/2009 |
| Last edited | 08/05/2009 |
| Date ISRCTN assigned | 08/05/2009 |
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