Condition category
Injury, Occupational Diseases, Poisoning
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
29/06/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr David Morgan

ORCID ID

Contact details

c/o Secretary to Professor Griffin
Orthopaedics & Trauma Department
Coventry & Warwickshire Hospital
Stoney Stanton Road
Coventry
CV1 4FH
United Kingdom
daimorgan@doctors.org.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0295132798

Study information

Scientific title

Acronym

Study hypothesis

Internal fixation of metacarpal and phalangeal fractures with bio-absorbable implants negates the need for removal of the implant, as with metallic implants, at a second operation with benefit to the patient and financial implications.

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

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Injury, Occupational Diseases, Poisoning: Fractures

Intervention

Please note that as of 21/06/10 it has been confirmed that this trial was stopped due to lack of staff and resources.

Prospective Randomised Controlled Trial. Metal vs bioabsorbable implants.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Total active range of motion (TAM) of affected digit
2. Grip strength measured with Jamar instrument
3. Complication rate
4. Fracture union rate
5. Implant removal rate
6. Financial cost of each treatment group

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/03/2004

Overall trial end date

30/10/2004

Reason abandoned

Lack of staff/facilities/resources

Eligibility

Participant inclusion criteria

50 patients with metacarpal and phalangeal fractures.
Sample size will take 12-18 months to recruit at current admission rates for the fractures being studied.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

50

Participant exclusion criteria

Does not match inclusion criteria

Recruitment start date

01/03/2004

Recruitment end date

30/10/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

c/o Secretary to Professor Griffin
Coventry
CV1 4FH
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

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

Funders

Funder type

Hospital/treatment centre

Funder name

University Hospitals Coventry and Warwickshire NHS Trust (UK)

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