Condition category
Injury, Occupational Diseases, Poisoning
Date applied
22/10/2009
Date assigned
02/12/2009
Last edited
09/02/2011
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 Joao Carlos Belloti

ORCID ID

Contact details

Federal University of Sao Paulo
Rua Borges Lagoa
783
5th floor
Sao Paulo
04038042
Brazil
+55 11 55716621
jcbelloti@unifesp.br

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Treatment of reducible unstable fractures of the distal extremity of the radius: external fixation versus percutaneous pinning - a randomised clinical trial

Acronym

Study hypothesis

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

Federal University of Sao Paulo (Universidade Federal de Sao Paulo) approved on the 9th August 2002 (ref: 0582/02)

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Colles' fracture

Intervention

Transulnar percutaneous pinning (De Palma) versus bridging external fixation. The total duration of follow-up was 2 years.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Measured at 6 months and 2 years:
1. Disability Arm Shoulder and Hand questionare (DASH)
2. Visual Analogue Scale (VAS)

Secondary outcome measures

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

Overall trial start date

01/03/2002

Overall trial end date

30/06/2004

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

100

Participant 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

Recruitment start date

01/03/2002

Recruitment end date

30/06/2004

Locations

Countries of recruitment

Brazil

Trial participating centre

Federal University of Sao Paulo
Sao Paulo
04038042
Brazil

Sponsor information

Organisation

Federal University of Sao Paulo (Brazil)

Sponsor details

Rua Borges Lagoa
783
5th floor
Sao Paulo
04038042
Brazil

Sponsor type

University/education

Website

http://www.unifesp.br

Funders

Funder type

Hospital/treatment centre

Funder name

Hospital Sao Paulo (Brazil)

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

1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20587064

Publication citations

  1. Results

    Belloti JC, Tamaoki MJ, Atallah AN, Albertoni WM, dos Santos JB, Faloppa F, Treatment of reducible unstable fractures of the distal radius in adults: a randomised controlled trial of De Palma percutaneous pinning versus bridging external fixation., BMC Musculoskelet Disord, 2010, 11, 137, doi: 10.1186/1471-2474-11-137.

Additional files

Editorial Notes