Distal Radius Internal Fixation Trial
| ISRCTN | ISRCTN07813725 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN07813725 |
| Secondary identifying numbers | 9191 |
- Submission date
- 14/05/2014
- Registration date
- 14/05/2014
- Last edited
- 19/02/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Simon John Pickard
Scientific
Scientific
Twmpath Lane
Oswestry
SY10 7AG
United Kingdom
| Phone | +44 1691 404226 |
|---|---|
| simon.pickard@rjah.nhs.uk |
Study information
| Study design | Randomised; Interventional and Observational; Design type: Not specified, Treatment, Qualitative |
|---|---|
| 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 | Surgical interventions for treating intra and extra-articular distal radius fractures: a randomised controlled trial of internal fixation with plate & screws versus percutaneous K-wiring |
| Study acronym | Distal Radius Internal Fixation Trial |
| Study objectives | The aim of this study is to assess the functional benefit/value for money of fixation of low-impact wrist fractures using a volar plate compared to K wiring. |
| Ethics approval(s) | 10/H1203/19 |
| Health condition(s) or problem(s) studied | Topic: Musculoskeletal disorders; Subtopic: Musculoskeletal (all Subtopics); Disease: Musculoskeletal |
| Intervention | K-wires, The number of K-wires used and whether they are buried or not depends on the surgeon's preference.; Volar plate, The volar approach and a fixed angled locking plate should be used for patients in the plate treatment group.; Follow Up Length: 12 month(s) |
| Intervention type | Other |
| Primary outcome measure | Disability of Arm Shoulder and Hand Questionnaire functional score at baseline, 3, 6 and 12 months |
| Secondary outcome measures | 1. EQ5D Questionnaire at baseline, 3, 6 and 12 months 2. Patient Diary kept for three most post-surgery 3. Patient Related Wrist Evaluation Questionnaire functional score at baseline 3, 6 and 12 months 4. Resource Usage Questionnaire at baseline, 3, 6 and 12 months 5. X-ray review at 3 and 12 months |
| Overall study start date | 01/10/2010 |
| Completion date | 16/12/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Planned Sample Size: 169; UK Sample Size: 169 |
| Total final enrolment | 170 |
| Key inclusion criteria | 1. The patient is skeletally mature (at least 16 years old). 2. The patient has had a low-impact trauma resulting in an isolated distal radius fracture as confirmed by Xray. Lowimpact fractures are those sustained in a fall from no higher than a standing position and at a velocity not above that of running. 3. The fracture is no more than 2 weeks old at the time of surgery. 4. There is no definite contraindication to, or definite indication for, one particular intervention and thus the surgeon is uncertain as to whether to treat the fracture with a plate or with kwiring. 5. NonEnglish speaking patients may be entered if there is a translator present at the time of consent and they have someone to help them fill in the questionnaires |
| Key exclusion criteria | 1. The patient has not given informed consent. 2. The patient is a child under 16 years of age. 3. The patient is not medically fit for surgery. 4. The fracture has previously been treated. 5. There is major displacement of articular fragments or obvious ligament injury. 6. The fracture is not displaced or is minimally displaced so that conservative treatment rather than surgery is considered appropriate. 7. If the fracture is accompanied by a compound injury with a Gustillo grading of 2 or higher. 8. The patient is unlikely to or unable, due to a cognitive impairment (as defined by the medical team responsible, this includes drug/alcohol abuse), to provide consent and complete questionnaires. 9. If the patient is not able to complete a year of followup Patients not eligible for the study will receive clinical care and treatment as they would per normal clinical practice. |
| Date of first enrolment | 01/10/2010 |
| Date of final enrolment | 16/12/2013 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Twmpath Lane
Oswestry
SY10 7AG
United Kingdom
SY10 7AG
United Kingdom
Sponsor information
The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust(UK)
Hospital/treatment centre
Hospital/treatment centre
Twmpath Lane
Oswestry
SY10 7AG
England
United Kingdom
"ROR" |
https://ror.org/030mbcp39 |
|---|
Funders
Funder type
Government
NIHR Research for Patient Benefit (RfPB); Grant Codes: PB-PG-0408-16214
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 2017 results presented at the British Orthopaedic Association conference in https://www.boa.ac.uk/uploads/assets/uploaded/d9355f25-8365-444d-b6648de243234932.pdf, see abstract 735 |
| IPD sharing plan |
Editorial Notes
19/02/2020: The following changes have been made:
1. A results abstract link has been added to publication and dissemination plan.
2. The final enrolment number has been added from the abstract.
14/02/2017: No publications found in PubMed, verifying study status with principal investigator.
