No registrations found.
ID
Source
Brief title
Health condition
distale radius fractuur
Sponsors and support
Intervention
Outcome measures
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.
Background 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.
Objective:
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.
Study design:
A prospective randomized controlled clinical trial.
Study population:
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).
Intervention:
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.
Study objective
Een kortere gipsduur gaat gepaard met een betere functionele uitkomst.
Study design
6 weeks, 3 months, 6 months en 12 months.
Intervention
1. Three weeks of plaster cast;
2. Five weeks of plaster cast.
Abdelali Bentohami
Academic Medical Center, Trauma Unit Department of Surgery
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5669111
a.bentohami@gmail.com
Abdelali Bentohami
Academic Medical Center, Trauma Unit Department of Surgery
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5669111
a.bentohami@gmail.com
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL3409 |
| NTR-old | NTR3552 |
| Other | METC Noord Holland : M011-059 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |