Treatment of reducible unstable fractures of the distal extremity of the radius: external fixation versus percutaneous pinning

ISRCTN	ISRCTN04892785
DOI	https://doi.org/10.1186/ISRCTN04892785
Protocol serial number	N/A
Sponsor	Federal University of Sao Paulo (Brazil)
Funder	Hospital Sao Paulo (Brazil)

Submission date: 22/10/2009
Registration date: 02/12/2009
Last edited: 09/02/2011

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

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Joao Carlos Belloti
Scientific

Federal University of Sao Paulo
Rua Borges Lagoa
783, 5th floor
Sao Paulo
04038042
Brazil

Phone	+55 11 55716621
Email	jcbelloti@unifesp.br

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Treatment of reducible unstable fractures of the distal extremity of the radius: external fixation versus percutaneous pinning - a randomised clinical trial
Study objectives	The aim of this study was to test the hypothesis that the modified DePalma method for percutaneous pinning would produce anatomical and functional results similar to those of external joint fixation in the treatment of unstable reducible intra or extra-articular fractures of the distal extremity of the radius in adult patients.
Ethics approval(s)	Federal University of Sao Paulo (Universidade Federal de Sao Paulo) approved on the 9th August 2002 (ref: 0582/02)
Health condition(s) or problem(s) studied	Colles' fracture
Intervention	Transulnar percutaneous pinning (De Palma) versus bridging external fixation. The total duration of follow-up was 2 years.
Intervention type	Other
Primary outcome measure(s)	Measured at 6 months and 2 years: 1. Disability Arm Shoulder and Hand questionare (DASH) 2. Visual Analogue Scale (VAS)
Key secondary outcome measure(s)	Measured at 6 months and 2 years: 1. Radiographic outcomes: radiographs in posteroanterior and lateral views were used for evaluation, and the following parameters were measured: volar inclination angle, radial inclination angle, presence of a stepped joint and consolidation. 2. Objective functional assessment: range of motion and grip 3. Complications and failures Functional and radiographic evaluations, pain measurements using the VAS, and applications of the DASH questionnaire were performed by professional orthopedists and physiotherapists who were not directly associated with the study
Completion date	30/06/2004

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	100
Key inclusion criteria	The patients were adults aged over 40 years (either sex) who presented with acute fractures with displacement up to 10 days old without previous treatment. The fractures were categorised using the Cooney classification 10 as unstable and reducible: type IIb and type IVb. Fractures were considered unstable if they presented three or more of the following factors at the initial radiographic examination: 1. Shortening of the radius by more than 5 mm 2. Dorsal angulation greater than 20 degrees 3. Joint incongruence 4. Fracture associated with the styloid process of the ulna 5. Dorsal comminution of the metaphysis 6. Aged greater than 60 years
Key exclusion criteria	1. Fractures with volar angulation (Smith fracture) 2. Joint margin fractures (Barton fracture) 3. Open or bilateral fractures 4. Fractures that could not be reduced 5. Patients with previous histories of degenerative disease, wrist joint trauma, or traumatic injuries associated with the fracture that would make it impossible to apply the proposed surgical methods or evaluate the results 6. Patients who refused to sign the free and informed consent statement
Date of first enrolment	01/03/2002
Date of final enrolment	30/06/2004

Locations

Countries of recruitment

Brazil

Study participating centre

Federal University of Sao Paulo

Sao Paulo
04038042
Brazil

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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	29/06/2010		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes