A randomised clinical pilot trial comparing intramedullary nailing with plate and screw fixation in the treatment of patients with an acute fracture of the distal tibia
| ISRCTN | ISRCTN08249684 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN08249684 |
| Secondary identifying numbers | 7111 |
- Submission date
- 14/07/2010
- Registration date
- 14/07/2010
- Last edited
- 17/09/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Juul Achten
Scientific
Scientific
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom
| j.achten@warwick.ac.uk |
Study information
| Study design | Single centre randomised interventional treatment trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study acronym | Management of Distal Tibia |
| Study objectives | The aim of the project is to perform a pragmatic pilot trial comparing two modes of treatments of distal tibia fractures. The two commonest treatment modalities are intramedullary nailing (where the nail is inserted in the tibia across the fracture) and screw and plate fixation. There is no agreement in the literature as to which treatment is best. The literature has shown that complications following the treatments mentioned above are very similar between the two modalities (infection, mal-union and non-union and re-operations) but no one has looked at the actual function of the patients following one treatment compared to the other. The objective is therefore to compare the two modes of treatments for distal tibia fractures, in terms of patient disability rating and quality of life. |
| Ethics approval(s) | MREC approved (ref: 8/H1210/1) |
| Health condition(s) or problem(s) studied | Topic: Musculoskeletal; Subtopic: Musculoskeletal (all Subtopics); Disease: Musculoskeletal |
| Intervention | 1. Intramedullary nailing: a nail is inserted in the tibia across the fracture 2. Screw and plate fixation: a plate and screw are used to fix the fracture Follow-up length: 12 months |
| Intervention type | Other |
| Primary outcome measure | Disability Rating Index. The principle measurement of the primary outcome measure will be at one year after injury. |
| Secondary outcome measures | 1. American Orthopaedic Foot and Ankle Society Hind foot Scale at 3, 6 and 12 months post-injury 2. Complications including wound dehiscence, infection, mal-union, non-union, reoperations, time in hospital and return 3. EQ-5D at 3, 6 and 12 months post-injury 4. Olerud and Molander ankle score at 3, 6 and 12 months post-injury |
| Overall study start date | 01/03/2008 |
| Completion date | 30/09/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | Planned Sample Size: 24 |
| Key inclusion criteria | Not provided at time of registration |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/03/2008 |
| Date of final enrolment | 30/09/2010 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom
CV2 2DX
United Kingdom
Sponsor information
University of Warwick (UK)
University/education
University/education
Gibbet Hill Road
Coventry
CV4 7AL
England
United Kingdom
| Website | http://www2.warwick.ac.uk |
|---|---|
"ROR" |
https://ror.org/01a77tt86 |
Funders
Funder type
Research organisation
AO Foundation (Switzerland)
Private sector organisation / Trusts, charities, foundations (both public and private)
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- AO Trauma, AO
- Location
- Switzerland
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/05/2012 | Yes | No |
