Condition category
Injury, Occupational Diseases, Poisoning
Date applied
18/07/2008
Date assigned
31/07/2008
Last edited
11/01/2012
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Florian Gebhard

ORCID ID

Contact details

Department of Trauma
Hand
and Reconstructive Surgery
University Hospital of Ulm
Steinhövelstr. 5
Ulm
89075
Germany
+49 731 5005 4500
florian.gebhard@uniklinik-ulm.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ORCHID Protocol V1.5 Final

Study information

Scientific title

Acronym

ORCHID

Study hypothesis

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

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).

Study design

Pragmatic, randomised, controlled, multicentre trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/09/2008

Overall trial end date

01/02/2012

Reason abandoned

Eligibility

Participant 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)

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

560

Participant 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

Recruitment start date

01/09/2008

Recruitment end date

01/02/2012

Locations

Countries of recruitment

Germany

Trial participating centre

Department of Trauma, Hand, and Reconstructive Surgery
Ulm
89075
Germany

Sponsor information

Organisation

German Research Council (Deutsche Forschungsgemeinschaft [DFG]) (Germany)

Sponsor details

Kennedyallee 40
Bonn
53175
Germany
+49 228 8851
postmaster@dfg.de

Sponsor type

Government

Website

http://www.dfg.de

Funders

Funder type

Government

Funder name

German Research Council (Deutsche Forschungsgemeinschaft [DFG]) (Germany) (ref: DFG GE1105/6-1)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2011 protocol in http://www.ncbi.nlm.nih.gov/pubmed/21426543

Publication citations

  1. Protocol

    Bartl C, Stengel D, Bruckner T, Rossion I, Luntz S, Seiler C, Gebhard F, Open reduction and internal fixation versus casting for highly comminuted and intra-articular fractures of the distal radius (ORCHID): protocol for a randomized clinical multi-center trial., Trials, 2011, 12, 84, doi: 10.1186/1745-6215-12-84.

Additional files

Editorial Notes