Open reduction and internal fixation versus closed reduction and casting for highly comminuted, intraarticular fractures of the distal radius
| ISRCTN | ISRCTN76120052 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN76120052 |
| Secondary identifying numbers | DRKS00000041 |
- Submission date
- 18/07/2008
- Registration date
- 31/07/2008
- Last edited
- 30/12/2020
- 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
Prof Florian Gebhard
Scientific
Scientific
Department of Trauma, Hand, and Reconstructive Surgery
University Hospital of Ulm
Steinhövelstr. 5
Ulm
89075
Germany
| Phone | +49 731 5005 4500 |
|---|---|
| florian.gebhard@uniklinik-ulm.de |
Study information
| Study design | Pragmatic, randomised, controlled, multicentre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| 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 | Open reduction and internal fixation versus closed reduction and casting for highly comminuted, intraarticular fractures of the distal radius |
| Study acronym | ORCHID |
| Study objectives | Open reduction and volar plate fixation of AO C-type fractures of the distal radius in patients >65 years will lead to a difference in Short-Form 36 (SF-36) Physical Component Scores (PCS) of 2.5 ± standard deviation 10 points after one year of follow-up, compared to closed reduction and cast stabilisation. |
| Ethics approval(s) | 1. Institutional Review Board (IRB) of the University of Ulm. Approved. (ref: 63/08) 2. Local IRBs of the participating institutions are currently reviewing the protocol. It is anticipated that all approvals will be provided by mid August 2008 (as of 18/07/2008). |
| Health condition(s) or problem(s) studied | Comminuted, intraarticular distal radial fractures in the elderly |
| Intervention | Target number of participants at completion of the trial is 2 x 252 (n = 504). Assuming a 10% drop-out rate, 560 patients will be recruited in total. Intervention A: Open reduction and internal fixation with volar locking plates Intervention B: Closed reduction and cast stabilisation |
| Intervention type | Other |
| Primary outcome measure | SF-36 PCS (V5, V6) Timepoints: V1 = Baseline V2 = Intervention V3 = Day 1 (+ 1 day) V4 = 2 weeks (+/- 3 days) V5 = 3 months (+/- 1 week) V6 = 1 year (+/- 2 months) |
| Secondary outcome measures | 1. All other SF-36 domains and SF-36 Mental Component Score (MCS) (V5, V6) 2. Disability of the Arm, Shoulder and Hand (DASH) questionnaire (V5, V6) 3. EuroQol 5D (EQ-5D) health outcome tool (V3, V5, V6) 4. Complications and serious adverse events (SAE), specifically treatment failures and/or surgical revisions, onset of complex regional pain syndrome (CRPS) type I (Duration of follow-up: 1 year [V6]) 5. Wrist range of motion (V5, V6) 6. Need for pain medication (Total duration of follow-up: 1 year [V6]) 7. Independent living (V3, V6) Timepoints: V1 = Baseline V2 = Intervention V3 = Day 1 (+ 1 day) V4 = 2 weeks (+/- 3 days) V5 = 3 months (+/- 1 week) V6 = 1 year (+/- 2 months) |
| Overall study start date | 01/09/2008 |
| Completion date | 01/02/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 560 |
| Total final enrolment | 149 |
| Key inclusion criteria | 1. Both males and females, age >65 years 2. Patients with isolated, closed, unilateral, radiologically confirmed distal radial fractures (AO 23 C1 - C3, as classified by the surgeon in charge) 3. Patients must have sustained their fracture <1 week before presentation to the centre 4. Patients who have not received specific treatment (e.g. prior attempt of closed reduction and casting) |
| Key exclusion criteria | 1. Clear indication for surgery (e.g. open fracture or severe soft tissue damage) 2. Clear contraindication for surgery (e.g. unacceptable anesthesiological risk) 3. Presence of factors associated with an unfavourable risk-benefit-ratio for surgery (e.g. poor skin and soft tissue conditions) 4. Mental disorders 5. Previous participation in the trial, or enrolment in another interventional study on distal radial fractures |
| Date of first enrolment | 01/09/2008 |
| Date of final enrolment | 01/02/2012 |
Locations
Countries of recruitment
- Germany
Study participating centre
Department of Trauma, Hand, and Reconstructive Surgery
Ulm
89075
Germany
89075
Germany
Sponsor information
German Research Council (Deutsche Forschungsgemeinschaft [DFG]) (Germany)
Government
Government
Kennedyallee 40
Bonn
53175
Germany
| Phone | +49 228 8851 |
|---|---|
| postmaster@dfg.de | |
| Website | http://www.dfg.de |
"ROR" |
https://ror.org/018mejw64 |
Funders
Funder type
Government
German Research Council (Deutsche Forschungsgemeinschaft [DFG]) (Germany) (ref: DFG GE1105/6-1)
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? |
|---|---|---|---|---|---|
| Protocol article | protocol | 22/03/2011 | Yes | No | |
| Results article | results in German | 14/11/2014 | 30/12/2020 | Yes | No |
Editorial Notes
30/12/2020: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
3. The DRKS number has been added.
