Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
A randomised controlled trial to compare the functional outcomes of two weight bearing protocols following open reduction and internal fixation of ankle fractures
Acronym
Study hypothesis
As well as developing the evidence-base and addressing this limitation identified by the systematic review, this proposed study has considerable clinical implications. Due to the frequency of this injury, the management of ankle fractures is important in the bed-management of orthopaedic wards and outpatient clinics in the National Health Service (NHS). Furthermore, surgeons at present commonly restrict their patients to non-weight bearing (hopping) for the initial six post-operative weeks. Some patients, particularly the elderly and weak find this difficult, and may be unable to walk during this period. As a result, these patients have a reduced level of independence, and may require hospital, or care home support during this period until they can begin weight bearing after fracture union. This has considerable cost implications, as well as affecting quality of life and independence. Younger patients in full time employment may also find work difficult with strict non-weight bearing protocols.
Ethics approval
Not provided at time of registration
Study design
Single-blind randomised controlled trial
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 below to request a patient information sheet
Condition
Closed ankle fractures
Intervention
Both the delayed and early weight bearing groups will have a backslab applied at the time of surgery. At 2 weeks this will be converted to a full non weight bearing cast in the delayed weight bearing group and an aircast boot (full weight bearing) in the early weight bearing group. At 6 weeks both groups will be allowed to fully bear weight free of cast or boot.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Olerud and Molander Subjective Ankle Score: This was chosen as the primary outcome measure since our research question asks that we assess patient's function primarily, which this outcome measure satisfies. Furthermore, previous authors have used this outcome measure in their investigations on ankle fracture management, and therefore, by using this outcome measure, we would be able to compare our findings to their results. Finally, although the reliability and validity of this tool has not been formally assessed for ankle fracture populations, the literature suggests that such a procedure has not been assessed with any outcome measure, and due to the other two factors, it was deemed that this would be the most appropriate outcome measure. Measured at 6 weeks, 3 months, 6 months, 1 year.
Secondary outcome measures
1. EQ-5D, assessed in the clinic setting. Although this measure is frequently assessed as a postal questionnaire, it will be assessed in the clinic to increase the response rate. Measured at 6 weeks, 3 months, 1 year; range of motion at 6 weeks
2. Range of ankle plantar flexion and dorsiflexion of both the injured and un-injured ankle. This will be assessed using goniometry and the bony landmarks of the head of the fifth metatarsal, and the fibula head
3. Patient reported outcome measures will also be a requirement within the UK National Health Service
4. Any post-operative complications such as infection, mal-union, implant loosening or breakage, deep vein thrombosis (DVT), measured at 6 weeks
5. Total time lost from work by asking each patient how long they required off work if applicable
6. Duration of in-patient hospital stay by reviewing the medical notes
7. Duration of physiotherapy rehabilitation by reviewing the physiotherapy notes, assessed at one year
8. Finally anatomical reduction and time to fracture union, assessed by an orthopaedic surgeon using clinical and radiographic examination. The latter assessment will be determined by satisfying the following criteria:
8.1. No bony tenderness on palpation around the fracture site
8.2. Pain-free weight bearing (determined as when the patient can stand solely on the injured leg reportedly pain-free for a total of 10 seconds)
8.3. Bridging callus on at least two cortices (orthogonal) on plain radiographs
Measured at 2 weeks
Overall trial start date
01/01/2011
Overall trial end date
31/12/2013
Reason abandoned
Lack of funding/sponsorship
Eligibility
Participant inclusion criteria
1. Patients with ankle fractures admitted for an open reduction internal fixation (ORIF) by the Trauma and Orthopaedic Department at St George's Hospital and St Thomas' Hospital
2. Radiological evidence of a fracture of the ankle requiring fixation which occurs alone (AO classification: 44-A1.2, 44-A1.3, 44-A2.1, 44-A2.2, 44-A2.3, 44.A3.1, 44-A3.2, 44-A3.3, 44-B1.1, 44-B1.2, 44-B1.3, 44.B2.1, 44-B2.2, 44-B2.3, 44-B3.1, 44-B3.2, 44-B3.3, 44-C1.1, 44-C1.2, 44-C1.3, 44.C2.1, 44-C2.2, 44-C2.3, 44-C3.1, 44-C3.2, 44-C3.3 ; Arbeitsgemeinschaft für Osteosynthesefragen/Orthopedic Trauma Association [AO/ATO] Classification, 2007)
3. Female and male subjects greater than or equal to 18 to 70 years
4. Body mass index (BMI) 16 - 33 kg/m^2 (minimum body weight 50 kg, maximum 140 kg)
5. Glasgow coma score (GCS) 15
6. Signed Informed Consent Form. The patient has to be able to give consent personally
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
76
Participant exclusion criteria
1. Inability to undertake assessment and treatment procedures
2. Contralateral lower limb injury
3. Inability to non-weight bear initially if allocated to non-weight bearing group
4. Unstable or relative stability ORIF due to surgical difficulty and fracture configuration or poor bone stock (e.g. osteoporosis) as determined by unstable valgus/varus testing on image intensifier in theatre and post-operative notes
5. Rupture to the syndesmosis
6. Previous ankle fracture
7. Anderson and Gustilo Grade II and III open fractures
8. Fixation requiring bone grafting
9. Active or past history of malignant tumour
10. Evidence of systemic or localised infection at time of surgery
11. Evidence of immunosuppression
12. Diagnosis of diabetes mellitus (Type I or Type II)
13. Gross osteoarthitic changes of the ankle joint (Grade 3 or above)
14. Previous surgical intervention to the operated ankle
15. Inability to attend out-patient physiotherapy appointments
16. Inability to independently mobilise with or without walking aids
17. Unwillingness to participate
Recruitment start date
01/01/2011
Recruitment end date
31/12/2013
Locations
Countries of recruitment
United Kingdom
Trial participating centre
St George's Hospital
London
SW17 0QT
United Kingdom
Sponsor information
Organisation
St George's Healthcare NHS Trust
Sponsor details
c/o Philip Mitchell
St George's Hospital
Blackshaw Road
Tooting
London
SW17 0QT
United Kingdom
+44 (0)20 8672 1255
Philip.mitchell@stgeorges.nhs.uk
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Charity
Funder name
St George's Hospital Orthopaedic Research Fund
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary