Treatment of reducible unstable fractures of the distal extremity of the radius: external fixation versus percutaneous pinning
| ISRCTN | ISRCTN04892785 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN04892785 |
| Secondary identifying numbers | N/A |
- Submission date
- 22/10/2009
- Registration date
- 02/12/2009
- Last edited
- 09/02/2011
- 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 Joao Carlos Belloti
Scientific
Scientific
Federal University of Sao Paulo
Rua Borges Lagoa
783, 5th floor
Sao Paulo
04038042
Brazil
| Phone | +55 11 55716621 |
|---|---|
| jcbelloti@unifesp.br |
Study information
| Study design | Randomised controlled 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 | Treatment of reducible unstable fractures of the distal extremity of the radius: external fixation versus percutaneous pinning - a randomised clinical trial |
| Study objectives | 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(s) | Federal University of Sao Paulo (Universidade Federal de Sao Paulo) approved on the 9th August 2002 (ref: 0582/02) |
| Health condition(s) or problem(s) studied | Colles' fracture |
| Intervention | Transulnar percutaneous pinning (De Palma) versus bridging external fixation. The total duration of follow-up was 2 years. |
| Intervention type | Other |
| Primary outcome measure | 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 study start date | 01/03/2002 |
| Completion date | 30/06/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 100 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/03/2002 |
| Date of final enrolment | 30/06/2004 |
Locations
Countries of recruitment
- Brazil
Study participating centre
Federal University of Sao Paulo
Sao Paulo
04038042
Brazil
04038042
Brazil
Sponsor information
Federal University of Sao Paulo (Brazil)
University/education
University/education
Rua Borges Lagoa
783, 5th floor
Sao Paulo
04038042
Brazil
| Website | http://www.unifesp.br |
|---|---|
"ROR" |
https://ror.org/02k5swt12 |
Funders
Funder type
Hospital/treatment centre
Hospital Sao Paulo (Brazil)
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 | 29/06/2010 | Yes | No |
