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
Protocol serial number	DRKS00000041
Sponsor	German Research Council (Deutsche Forschungsgemeinschaft [DFG]) (Germany)
Funder	German Research Council (Deutsche Forschungsgemeinschaft [DFG]) (Germany) (ref: DFG GE1105/6-1)

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

Department of Trauma, Hand, and Reconstructive Surgery
University Hospital of Ulm
Steinhövelstr. 5
Ulm
89075
Germany

Phone	+49 731 5005 4500
Email	florian.gebhard@uniklinik-ulm.de

Study information

Primary study design	Interventional
Study design	Pragmatic, randomised, controlled, multicentre trial
Secondary study design	Randomised controlled trial
Study type	Participant 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(s)	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)
Key secondary outcome measure(s)	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)
Completion date	01/02/2012

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	All
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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 in German	14/11/2014	30/12/2020	Yes	No
Protocol article	protocol	22/03/2011		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

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.