Comparison of Internal Fixation of Metacarpal and Phalangeal Fractures with Metal or Bioabsorbable Implants

ISRCTN	ISRCTN63388229
DOI	https://doi.org/10.1186/ISRCTN63388229
Protocol serial number	N0295132798
Sponsor	Department of Health
Funder	University Hospitals Coventry and Warwickshire NHS Trust (UK)

Submission date: 30/09/2004
Registration date: 30/09/2004
Last edited: 29/06/2010

Recruitment status: Stopped
Overall study status: Stopped
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

Mr David Morgan
Scientific

c/o Secretary to Professor Griffin
Orthopaedics & Trauma Department
Coventry & Warwickshire Hospital
Stoney Stanton Road
Coventry
CV1 4FH
United Kingdom

Email	daimorgan@doctors.org.uk

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	30/10/2004
Reason abandoned (if study stopped)	Lack of staff/facilities/resources

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	50
Key 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.
Key exclusion criteria	Does not match inclusion criteria
Date of first enrolment	01/03/2004
Date of final enrolment	30/10/2004

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

c/o Secretary to Professor Griffin

Coventry
CV1 4FH
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