Condition category
Injury, Occupational Diseases, Poisoning
Date applied
27/05/2011
Date assigned
14/06/2011
Last edited
03/11/2014
Prospective/Retrospective
Prospectively 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 Jorge Raduan Neto

ORCID ID

Contact details

Rua Borge Lagoa nº 778 Vila Clementino
São Paulo
04038-032
Brazil
raduan.neto@gmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

External fixation or volar plating for treating deviated distal radius fracture: randomized clinical trial

Acronym

Study hypothesis

Osteosynthesis with volar blocked plate has functional, anatomic results, failure and complication rate similar to the treatment with external fixation method

Ethics approval

Ethics Committee of Federal Univeristy of São Paulo, São Paulo, Brazil (Comitê de ética em pesquisa da Universidade Federal de Sâo Paulo) ref: 0011-11, January 2011

Study design

Randomized clinical 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

Deviated distal radius fracture

Intervention

1. The patients will be allocated in two treatment options, regarding to operative treatment of distal radius fracture:
1.1. Volar platting, which consists of an open reduction and internal fixation using a volar plate
1.2. External fixation – which consist of a transarticular bridging fixation. All the patients will be followed at 1, 3, 6,9,12 weeks and 6, 12 months.
2. All patients will be followed by the research team for 1 year

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Functional assessment
2. Patient satisfaction with the surgical method
3. All outcomes (DASH, SF-36, VAS) will be applied at 3,6,12 weeks and 6 and 12 months

Secondary outcome measures

1. Anatomic and radiographic
2. Complications
3. Method failure

Overall trial start date

01/03/2012

Overall trial end date

01/03/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Adult patients of both genders
2. Acute fractures (up to 15 days) in the distal edge of the radius, reducible and unstable, who have not been submitted to previous surgical treatments.
3. Palmar blocked plate or with external fixation method for treating desviated distal radius fracture

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

36 patients in each group

Participant exclusion criteria

1. Patients with marginal or irreducible fractures
2. Previous history of degenerative or traumatic pathology in the articulation of the wounded or contralateral wrist
3. Bilateral fracture, exposed fractures, with tendinous or neurovascular injuries
4. Patients with systemic diseases or traumatic injuries associated with the fracture, which restrict application of the methods or assessment of the results
5. Refusal to the consent term

Recruitment start date

01/03/2012

Recruitment end date

01/03/2014

Locations

Countries of recruitment

Brazil

Trial participating centre

Rua Borge Lagoa nº 778 Vila Clementino
São Paulo
04038-032
Brazil

Sponsor information

Organisation

Federal University of São Paulo (Brazil)

Sponsor details

c/o Dr Jorge Raduan Neto
Rua Borges Lagoa nº 778
São Paulo
04038-032
Brazil

Sponsor type

University/education

Website

Funders

Funder type

Research organisation

Funder name

Foundation for Research Support of São Paulo (Fundação de amparo à pesquesa do esado de São Paulo - FAPESP)

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

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24597699

Publication citations

  1. Results

    Raduan Neto J, de Moraes VY, Gomes Dos Santos JB, Faloppa F, Belloti JC, Treatment of reducible unstable fractures of the distal radius: randomized clinical study comparing the locked volar plate and external fixator methods: study protocol., BMC Musculoskelet Disord, 2014, 15, 65, doi: 10.1186/1471-2474-15-65.

Additional files

Editorial Notes