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ISRCTN
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ISRCTN04892785
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ClinicalTrials.gov identifier
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Public title
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Treatment of reducible unstable fractures of the distal extremity of the radius: external fixation versus percutaneous pinning
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Scientific title
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Treatment of reducible unstable fractures of the distal extremity of the radius: external fixation versus percutaneous pinning - a randomised clinical trial
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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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.
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Lay summary
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Ethics approval
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Federal University of Sao Paulo (Universidade Federal de Sao Paulo) approved on the 9th August 2002 (ref: 0582/02)
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Study design
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Randomised controlled trial
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Countries of recruitment
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Brazil
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Disease/condition/study domain
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Colles' fracture
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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01/03/2002
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Anticipated end date
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30/06/2004
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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100
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Interventions
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Transulnar percutaneous pinning (De Palma) versus bridging external fixation. The total duration of follow-up was 2 years.
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Primary outcome measure(s)
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Measured at 6 months and 2 years:
1. Disability Arm Shoulder and Hand questionare (DASH)
2. Visual Analogue Scale (VAS)
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Secondary outcome measure(s)
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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
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Sources of funding
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Hospital Sao Paulo (Brazil)
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Trial website
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Publications
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1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20587064
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Contact name
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Dr
Joao Carlos
Belloti
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Address
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Federal University of Sao Paulo
Rua Borges Lagoa
783, 5th floor
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City/town
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Sao Paulo
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Zip/Postcode
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04038042
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Country
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Brazil
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Tel
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+55 11 55716621
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Fax
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+55 11 55716621
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Email
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jcbelloti@unifesp.br
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Sponsor
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Federal University of Sao Paulo (Brazil)
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Address
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Rua Borges Lagoa
783, 5th floor
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City/town
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Sao Paulo
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Zip/Postcode
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04038042
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Country
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Brazil
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Sponsor website:
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http://www.unifesp.br
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Date applied
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22/10/2009
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Last edited
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09/02/2011
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Date ISRCTN assigned
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02/12/2009
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