External fixation or volar plating for treating deviated distal radius fracture
| ISRCTN | ISRCTN09599740 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN09599740 |
| Secondary identifying numbers | N/A |
- Submission date
- 27/05/2011
- Registration date
- 14/06/2011
- Last edited
- 03/11/2014
- 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 Jorge Raduan Neto
Scientific
Scientific
Rua Borge Lagoa nº 778 Vila Clementino
São Paulo
04038-032
Brazil
| raduan.neto@gmail.com |
Study information
| Study design | Randomized clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 01/03/2012 |
| Completion date | 01/03/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 36 patients in each group |
| 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 |
Locations
Countries of recruitment
- Brazil
Study participating centre
Rua Borge Lagoa nº 778 Vila Clementino
São Paulo
04038-032
Brazil
04038-032
Brazil
Sponsor information
Federal University of São Paulo (Brazil)
University/education
University/education
c/o Dr Jorge Raduan Neto
Rua Borges Lagoa nº 778
São Paulo
04038-032
Brazil
"ROR" |
https://ror.org/02k5swt12 |
|---|
Funders
Funder type
Research organisation
Foundation for Research Support of São Paulo (Fundação de amparo à pesquesa do esado de São Paulo - FAPESP)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 | 05/03/2014 | Yes | No |
