Treatment of Jones fracture: operative versus non operative treatment
| ISRCTN | ISRCTN35403233 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN35403233 |
| Protocol serial number | N0280163204 |
| Sponsor | Record Provided by the NHSTCT Register - 2006 Update - Department of Health |
| Funders | Wirral Hospitals NHS Trust, NHS R&D Support Funding |
- 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
Scientific
Dept of Orthopaedics
Wirral Hospital NHS Trust
Arrowe Park Road
Upton
Wirral
CH49 5PE
United Kingdom
| Phone | +44 (0)785 9893 179 |
|---|---|
| arvindrawal@yahoo.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
American ankle and foot scoring system visual analogue scale for patient satisfaction, radiological analysis re time to unite. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 30/08/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 70 |
| 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
- United Kingdom
- England
Study participating centre
Dept of Orthopaedics
Wirral
CH49 5PE
United Kingdom
CH49 5PE
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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.
