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 designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific titleTreatment of Jones fracture: operative versus non operative treatment
Study objectivesThe 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) studiedInjury, Occupational Diseases, Poisoning: Jones fracture
InterventionProspective 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 typeOther
Primary outcome measureAmerican ankle and foot scoring system visual analogue scale for patient satisfaction, radiological analysis re time to unite.
Secondary outcome measuresNot provided at time of registration
Overall study start date01/05/2005
Completion date30/08/2006

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants35 patients in each group.
Key inclusion criteriaAll patients with Jones fracture of 5th metatarsal
Key exclusion criteria1.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 enrolment01/05/2005
Date of final enrolment30/08/2006

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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

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