External fixation or volar plating for treating deviated distal radius fracture

ISRCTN	ISRCTN09599740
DOI	https://doi.org/10.1186/ISRCTN09599740
Protocol serial number	N/A
Sponsor	Federal University of São Paulo (Brazil)
Funder	Foundation for Research Support of São Paulo (Fundação de amparo à pesquesa do esado de São Paulo - FAPESP)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Jorge Raduan Neto
Scientific

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

Email	raduan.neto@gmail.com

Primary study design	Interventional
Study design	Randomized clinical trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	External fixation or volar plating for treating deviated distal radius fracture: randomized clinical trial
Study objectives	Osteosynthesis with volar blocked plate has functional, anatomic results, failure and complication rate similar to the treatment with external fixation method
Ethics approval(s)	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
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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
Key secondary outcome measure(s)	1. Anatomic and radiographic 2. Complications 3. Method failure
Completion date	01/03/2014

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	36
Key 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
Key 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
Date of first enrolment	01/03/2012
Date of final enrolment	01/03/2014

Rua Borge Lagoa nº 778 Vila Clementino

São Paulo
04038-032
Brazil

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	05/03/2014		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes