Condition category
Injury, Occupational Diseases, Poisoning
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
19/10/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.dh.gov.uk/Home/fs/en

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

Publication citations

Additional files

Editorial Notes

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