Condition category
Injury, Occupational Diseases, Poisoning
Date applied
29/04/2009
Date assigned
08/05/2009
Last edited
13/10/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
25% of ankle fracture patients are over the age of 60. The proven treatments suitable in young patients are not necessarily appropriate in later life. The ankle bones, leg circulation and skin quality all become more fragile with age. To achieve the best result in treating ankle fractures, the key objective must be to ensure the bones around the ankle joint heal in the best position to maintain function. For most patients, this requires an operation to set the bones back into position by inserting a metal plate and screws. However, some patients may be treated by manipulating the bones back into position under anaesthesia and then applying a close contact cast, which is a standard plaster cast applied by a specialised technique. Both of these treatments have advantages and disadvantages for older patients. The plates and screws are good at holding the exact position but can fail if the bone is weak or if the surgical wound does not heal or becomes infected. The alternative, manipulation and a plaster cast, has been found to be less good at holding the position in some people. It can also cause skin problems from the pressure of the plaster. In the past, most patients have been treated with plate and screw surgery. However, a plaster cast technique developed to treat diabetic patients has now been successfully modified for use in older patients with unstable ankle fractures. The aim of this study is to determine whether this modified cast treatment using a 'close contact cast' is equivalent to the operation using plates and screws, i.e. it gives the same results without the need for open surgery and the risks of wound healing problems and infection.

Who can participate?
Patients aged over 60 with an ankle fracture

What does the study involve?
Participants are randomly allocated to be treated with either the close contact cast technique or with the standard treatment of open surgery. We then assess the healing of the bone and skin, how well the ankle moves, and how well the patients are managing overall at 6 months after the injury.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
John Radcliffe Hospital (UK)

When is the study starting and how long is it expected to run for?
October 2009 to October 2014

Who is funding the study?
NIHR Health Technology Assessment Programme - HTA (UK)

Who is the main contact?
Prof. Keith Willett

Trial website

Contact information

Type

Scientific

Primary contact

Prof Keith Willett

ORCID ID

Contact details

Kadoorie Centre
John Radcliffe Hospital
Oxford
OX3 9DU
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 07/37/61

Study information

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)

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

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Displaced unstable fracture of the ankle

Intervention

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.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

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 measures

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

Overall trial start date

01/10/2009

Overall trial end date

01/10/2014

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

620

Participant 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

Recruitment start date

01/10/2009

Recruitment end date

01/10/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

John Radcliffe Hospital
Oxford
OX3 9DU
United Kingdom

Sponsor information

Organisation

University of Oxford (UK)

Sponsor details

Clinical Trials and Research Governance
Manor House
John Radcliffe Hospital
Headington
Oxford
OX3 9DZ
United Kingdom

Sponsor type

University/education

Website

http://www.ox.ac.uk

Funders

Funder type

Government

Funder name

Health Technology Assessment Programme

Alternative name(s)

NIHR Health Technology Assessment Programme, HTA

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

01/06/2016

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24621174
2016 results in: https://www.ncbi.nlm.nih.gov/pubmed/27727383

Publication citations

  1. Protocol

    Willett K, Keene DJ, Morgan L, Gray B, Handley R, Chesser T, Pallister I, Tutton E, Knox C, Lall R, Briggs A, Lamb SE, 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., BMC Musculoskelet Disord, 2014, 15, 79, doi: 10.1186/1471-2474-15-79.

Additional files

Editorial Notes

13/10/2016: Publication reference added. 19/04/2016: Publication reference added.