Treatment of Jones fracture: operative versus non operative treatment

ISRCTN	ISRCTN35403233
DOI	https://doi.org/10.1186/ISRCTN35403233
Secondary identifying numbers	N0280163204

Submission date: 29/09/2006
Registration date: 29/09/2006
Last edited: 19/10/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Injury, Occupational Diseases, Poisoning

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Arvind Rawal
Scientific

Dept of Orthopaedics
Wirral Hospital NHS Trust
Arrowe Park Road
Upton
Wirral
CH49 5PE
United Kingdom

Phone	+44 (0)785 9893 179
Email	arvindrawal@yahoo.com

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Scientific title	Treatment of Jones fracture: operative versus non operative treatment
Study objectives	The aim of this study is to determine whether operative treatment of Jones fracture gives better outcome.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/05/2005
Completion date	30/08/2006

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	35 patients in each group.
Key inclusion criteria	All patients with Jones fracture of 5th metatarsal
Key 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
Date of first enrolment	01/05/2005
Date of final enrolment	30/08/2006

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Dept of Orthopaedics

Wirral
CH49 5PE
United Kingdom

Sponsor information

Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Government

The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom

Phone	+44 (0)20 7307 2622
Email	dhmail@doh.gsi.org.uk
Website	http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Wirral Hospitals NHS Trust

No information available

NHS R&D Support Funding

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

19/10/2016: No publications found in PubMed, verifying study status with principal investigator.