Current literature indicates that one week of cast or brace immobilisation is safe, however, no level one evidence is available. This trial aims to compare one week of brace immobilisation with three weeks of cast immobilisation in non- or minimally…
ID
Source
Brief title
Condition
- Bone disorders (excl congenital and fractures)
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
patient-reported outcome after six months measured by PRWE (Patient Related
Wrist Evaluation) score.
The PRWE is a validated 15-item (scored 1-10) self-reported questionnaire and
is the best questionnaire for evaluating the patient reported outcome in case
of DRFs. Patients rate their outcome on a 0-10 scale on pain and functional
outcome, and scores will be transformed to a 0-100 score. A higher score
indicates greater disability.
Secondary outcome
1. The qDASH (Quick Disabilities of the Arm, Shoulder and Hand) score after 6
weeks, and 6 months
2. PRWE after 6 weeks
3. Range of motion after 6 weeks, and 6 months
4. Pain (VAS-score) at arrival at ED, after cast/brace is applied, in the first
week after brace/cast removal, 6 weeks, and 6 months
5. Radiological outcome at 6 weeks, and 6 months
6. Complications
7. Cost-effectiveness (measured by EQ-5D, iMCQ and iPCQ questionnaires)
The DASH Outcome Measure is a validated 30-item self-reported questionnaire for
patients with disorders of the arm, shoulder and hand. The QuickDASH (qDASH) is
the shortened version of the DASH Outcome Measure, using 11 items instead of 30
(scored 1-5) to measure pain and functional outcome. At least 10 of the 11
items must be completed to calculate a score. The scores will be transformed to
a 0-100. A higher score indicates greater disability.
The range of motion will be measured by using a goniometer:
volar/dorsal flexion, radial/ulnar deviation, and pronation/supination, will be
determined. The pain will be measured by using the VAS-score. VAS-score is a
widely used method for pain assessments. Patients score their pain on a scale
of 1-10. A higher score indicated a higher level of pain. The VAS-score will be
measured on the ED at arrival and after application of the brace of cast.
Patients will also receive a dairy after cast removal to record their pain
score.
Radiological outcome will be measured; dorsal and volar tilt in degrees,
radial height in millimetres and ulnar variance in millimetres will be
calculated directly after trauma, and after six weeks and six months.
Complications contain secondary displacement (radial shortening >3mm, dorsal
tilt >10° or intra-articular step-off >2mm), delayed/non-union,
re-interventions, complex regional pain syndrome (CRPS), tendon injuries
(ruptures and tendinitis), nerve injuries (carpal tunnel syndrome and lesions),
and distal radial ulnar joint disability.
Cost-effectiveness and cost-utility of non- or minimally displaced DRFs treated
by three weeks of cast immobilisation or one week of brace immobilisation will
be analysed. The perspective of this study is societal, and therefore both
direct and indirect costs due to the DRF will be considered. Direct costs will
include treatment, follow up visits at the outpatient clinic, additional visits
to health care professionals, and the treatment of complications. Non-health
care related costs include expenses to travel to and from the hospital.
Indirect costs are based on absenteeism of work, or loss of working hours due
to cast-immobilisation or pain. To estimate health care costs, the
Friction-Cost method will be used to analyse the loss of production for an
individual worker. This analysis is based on a cost effectiveness analysis of a
study on the non-operative versus the operative treatment of DRFs. To analyse
cost-effectiveness and cost-utility, the EuoQuol 5D (EQ-5D), Productivity Cost
Questionnaire (iPCQ) and the Medical Consumption questionnaires (iMCQ) will be
used.
Background summary
Currently, non- or minimally displaced distal radius fractures are treated by
three to five weeks of cast immobilisation. Many patients with a distal radius
fracture suffer from long-term functional restrictions, which might be related
to stiffness due to cast immobilisation.
Study objective
Current literature indicates that one week of cast or brace immobilisation is
safe, however, no level one evidence is available. This trial aims to compare
one week of brace immobilisation with three weeks of cast immobilisation in
non- or minimally displaced distal radius fractures. We hypothesize that one
week of brace immobilisation is non-inferior to three or more weeks of cast
immobilisation.
Study design
This study will be conducted as a multicenter-prospective randomized clinical
trial in three hospitals. In this study three weeks of cat immobilization is
compared to one week of brace immobilization. Patients will be treated in a
lower arm cast or a prefab brace. Post-immobilization treatment will be equal
for both groups. The study will start at the 1th of January 2023.
Intervention
Intervention group: one week of brace immobilization
control group: three weeks of cast immobilization (general care)
Study burden and risks
Both treatment options are generally accepted ways of treatment.
Up to 30% of the patients with a distal radius fracture suffer form long-term
functional restrictions following cast immobilization. As non or minimally
displaced fracture are considered stable fractures, they did not displace
during the trauma, so they will not displace later on, the risk of secondary
displacement in these fractures is negligible.
Gladiolenlaan 19
Bennebroek 2121SM
NL
Gladiolenlaan 19
Bennebroek 2121SM
NL
Listed location countries
Age
Inclusion criteria
1. 18-50 years (to eliminate osteoporosis);
2. Primary non- or minimally gedisplaced DRF;
3. Independent for activities of daily living.
Exclusion criteria
1. Fracture of the contralateral wrist;
2. Ipsilateral fractures, proximal of the DRF;
3. Pre-existent abnormalities or functional deficits of the fractured wrist;
4. Open fractures;
5. Poly trauma patiënten
6. Language ability to understand the Dutch patient information and
questionnaires.
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 |
|---|---|
| CCMO | NL81638.029.22 |