Condition category
Musculoskeletal Diseases
Date applied
14/07/2010
Date assigned
14/07/2010
Last edited
17/09/2013
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 Juul Achten

ORCID ID

Contact details

Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom
j.achten@warwick.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

7111

Study information

Scientific title

Acronym

Management of Distal Tibia

Study hypothesis

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

MREC approved (ref: 8/H1210/1)

Study design

Single centre randomised interventional treatment trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/03/2008

Overall trial end date

30/09/2010

Reason abandoned

Eligibility

Participant inclusion criteria

Not provided at time of registration

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Planned Sample Size: 24

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/03/2008

Recruitment end date

30/09/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom

Sponsor information

Organisation

University of Warwick (UK)

Sponsor details

Gibbet Hill Road
Coventry
CV4 7AL
United Kingdom

Sponsor type

University/education

Website

http://www2.warwick.ac.uk

Funders

Funder type

Research organisation

Funder name

AO Foundation (Switzerland)

Alternative name(s)

AO

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

Switzerland

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

2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22529095

Publication citations

  1. Results

    Mauffrey C, McGuinness K, Parsons N, Achten J, Costa ML, A randomised pilot trial of "locking plate" fixation versus intramedullary nailing for extra-articular fractures of the distal tibia., J Bone Joint Surg Br, 2012, 94, 5, 704-708, doi: 10.1302/0301-620X.94B5.28498.

Additional files

Editorial Notes