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DR PIP II: Distal Radius Plaster Immobilization Period II


- candidate number27599
- NTR NumberNTR6600
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR28-jul-2017
- Secondary IDsVolgt 
- Public TitleDR PIP II: Distal Radius Plaster Immobilization Period II
- Scientific TitleDislocated distal radial fractures in adult patients: Four weeks versus Six weeks of cast immobilization after reduction, a randomized controlled trial.
- ACRONYMDR PIP II
- hypothesisThe expectation of this study is that shorter duration of plaster cast immobilization is beneficial for the patients.
- Healt Condition(s) or Problem(s) studiedDistal radius fracture, Wrist fracture, Range of motion (ROM), Dislocation
- Inclusion criteria1. Age > 18 years;
2. Primary displaced unilateral fracture of the distal radius;
3. Independent for activities of daily living.
- Exclusion criteria1. Fracture of contralateral wrist;
2. Other fractures at the ipsilateral upper extremity (excluded fractures of the hand and fractures of the styloid process of the ulna);
3. Pre-existent abnormalities or functional deficits of the fractured wrist;
4. Open fractures.
- mec approval receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-okt-2017
- planned closingdate31-dec-2019
- Target number of participants70
- Interventionsfour versus six weeks of cast immobilization
- Primary outcomethe QuickDASH (Disabilities of the Arm, Shoulder and Hand) score, and PRWE (Patient Related Wrist Evaluation) score after one year
- Secondary outcome1. Functional outcome (QuickDash/PRWE) after 8 weeks, 3 months and 6 months
2. Range of motion
3. Pain level
4. Lidström-score
5. Fracture related complications
- Timepoints6 weeks - 12 weeks - 6 months - 1 year
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES Eva van Delft
- CONTACT for SCIENTIFIC QUERIES J. Vermeulen
- Sponsor/Initiator VU University Medical Center
- Funding
(Source(s) of Monetary or Material Support)
- Publications
- Brief summaryUp to 30% of patients with a dislocated distal radius fracture suffer from long-term functional restrictions following conservative treatment. It remains unclear, whether duration of cast immobilisation influences functional outcome. The aim of the study is to evaluate whether the functional outcome of dislocated distal radial fractures could be improved by shortening the period of immobilization so that reactivation can start earlier. In this study a four weeks of plaster cast immobilization period is compared with six weeks of immobilization for adult patients with reduced distal radial fractures.
The expectation of this study is that shorter duration of plaster cast immobilization is beneficial for the patients. This risk of specific complications is low and generally similar in both treatment options. Follow-up is standardized according to current trauma guidelines; present literature indicates that both treatment options from this study are accepted protocols for treatment of displaced distal radius fractures. This trial will provide level-1 evidence for the comparison of functional outcome between the two treatment options for dislocated distal radial fractures.
- Main changes (audit trail)
- RECORD28-jul-2017 - 13-aug-2017


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