Condition category
Injury, Occupational Diseases, Poisoning
Date applied
30/07/2010
Date assigned
27/10/2010
Last edited
08/02/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Miss Caroline Hing

ORCID ID

Contact details

St George's Hospital
Tooting
London
SW17 0QT
United Kingdom

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

http://www.stgeorges.nhs.uk/

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

Publication citations

Additional files

Editorial Notes

08/02/2016: This study was stopped due to lack of funds 05/02/2016: No publications found, verifying study status with principal investigator