|- candidate number||13188|
|- NTR Number||NTR3552|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||31-jul-2012|
|- Secondary IDs||M011-059 METC Noord Holland|
|- Public Title||Duur gipsbehandeling bij niet gereponeerde polsfracturen.|
|- Scientific Title||Distal Radius Plaster Immobilization Period I. A randomized trial comparing three weeks of plaster cast immobilization with five weeks of plaster cast immobilization in adult patients with distal radius fractures.|
|- ACRONYM||DR PIP I|
|- hypothesis||Een kortere gipsduur gaat gepaard met een betere functionele uitkomst.|
|- Healt Condition(s) or Problem(s) studied||Distal radius fracture|
|- Inclusion criteria||1. Age > 18 years;|
2. Unilateral fracture of distal radius without misalignment (dorsal angulation >15°, volar tilt >20°, radial inclination >15° and, ulnar variance >5mm);
3. Independent for activities of daily living.
|- Exclusion criteria||1. Fracture of contralateral arm;|
2. Other fractures at the ipsilateral arm (excluded carpal fractures);
3. Pre-existent abnormalities fractured distal radius;
4. Open fractures.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-aug-2012|
|- planned closingdate||1-aug-2013|
|- Target number of participants||70|
|- Interventions||1. Three weeks of plaster cast;|
2. Five weeks of plaster cast.
|- Primary outcome||Functional outcome in adult patients with a distal radius fracture as assessed using the:|
1. Quick Disability of Arm, Shoulder and Hand (DASH) score16;
2. Patient Related Wrist Evaluation.
|- Secondary outcome||Secondary Objective(s):|
1. Range of motion;
2. Pain (assessed by the VAS scale);
3. Time to union;
4. Complications: complex regional pain syndrome and mal/ nonunion.
|- Timepoints||6 weeks, 3 months, 6 months en 12 months.|
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||MD Abdelali Bentohami|
|- CONTACT for SCIENTIFIC QUERIES||MD Abdelali Bentohami|
|- Sponsor/Initiator ||Spaarne Hospital|
(Source(s) of Monetary or Material Support)
|- Brief summary||Rationale: |
Up to 30% of patients suffer from long-term functional restrictions following conservative treatment. Whether duration of cast immobilisation influences functional outcome remains unclear.
The aim of the study is to prove that the functional outcome minimally displaced distal radial fractures is better after three weeks of plaster cast immobilization than after five weeks of plaster cast immobilization.
A prospective randomized controlled clinical trial.
Adult (>18 years) (independent in activities of daily living) patients with a displaced distal radius fracture (Dorsal angulation > 15° or volar angulation <20°, Radial inclination < 15°, radial shortening > 5 mm, Radial displacement > 2 mm).
Three weeks of plaster cast immobilization versus five weeks of plaster cast immobilization.
Main study parameters:
Primary outcome parameters: Patient related wrist evaluation (PRWE) Quick Disability of Arm, Shoulder and Hand (QUICKDASH) score, and secondary parameters: range of motion, pain level (VAS), cost-effectiveness analysis.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
The expectation of this study is that shorter duration of plaster cast immobilisation is beneficial for the patient with a distal radius fracture. This risk of specific complications is low and generally similar in both treatment options. Moreover, the burden of the study is not much higher compared to standard treatment. Follow-up is standardized according to current trauma guidelines. Literature indicates that both treatment options from the study are accepted for displaced distal radius fractures. No clear advantage for one treatment options is found at present in the literature, although there is no level I evidence present.
|- Main changes (audit trail)|
|- RECORD||31-jul-2012 - 13-aug-2012|