Contact information
Type
Scientific
Primary contact
Dr Arvind Rawal
ORCID ID
Contact details
Dept of Orthopaedics
Wirral Hospital NHS Trust
Arrowe Park Road
Upton
Wirral
CH49 5PE
United Kingdom
+44 (0)785 9893 179
arvindrawal@yahoo.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0280163204
Study information
Scientific title
Treatment of Jones fracture: operative versus non operative treatment
Acronym
Study hypothesis
The aim of this study is to determine whether operative treatment of Jones fracture gives better outcome.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Injury, Occupational Diseases, Poisoning: Jones fracture
Intervention
Prospective study with randomisation of type II Jones Fractures into operative versus non-operative groups.
Non-surgical treatment group patients will be placed in a short leg (below knee) non weight bearing cast for 6-8 weeks, followed by a weight bearing cast for an additional 6-8 weeks.
Surgical treatment group patients will undergo open reduction and internal fixation of the fracture with intramedullary screw.
All patients will be given follow up appointments at 2,4,8,12, and 16 week intervals. Radiographs will be similarly scheduled for 4, 8,12 and 16 week intervals to assess fracture healing. Final AOFAS score, radiological assessment and patient satisfaction score at 16 weeks will be used as outcome measures and the two groups will be compared.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
American ankle and foot scoring system visual analogue scale for patient satisfaction, radiological analysis re time to unite.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/05/2005
Overall trial end date
30/08/2006
Reason abandoned
Eligibility
Participant inclusion criteria
All patients with Jones fracture of 5th metatarsal
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
35 patients in each group.
Participant exclusion criteria
1.Torg Type 3 fractures (Established non union)
2. Refracture after previous healing with surgical / non surgical treatment
3. Patients who do not wish to participate in the study and choose to opt for surgical or non surgical treatment without randomisation
4. Patients below 16 yrs of age
5. Patients with mental health problems or learning disabilities
Recruitment start date
01/05/2005
Recruitment end date
30/08/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Dept of Orthopaedics
Wirral
CH49 5PE
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Wirral Hospitals NHS Trust
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
NHS R&D Support Funding
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