Open reduction and internal fixation versus closed reduction and casting for highly comminuted, intraarticular fractures of the distal radius

Conditions

Comminuted, intraarticular distal radial fractures in the elderly Injury, Occupational Diseases, Poisoning Fracture at wrist and hand level

Wayne Kuznar, Christoph Bärtl

MD Conference Express2014-12-01

10.1177/155989771441007

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.

Bartl C, Stengel D, Bruckner T, Rossion I, Luntz S, Seiler C, Gebhard F.

2011-03-2225 citations

10.1186/1745-6215-12-84

Interventions

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 an

Eligibility

Sex/Gender

All

Inclusion criteria

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)

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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)	—

Measure

Time frame

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)

—

Countries

Germany

Outcome results

None listed