To evaluate the cost-effectiveness of a supportive bandage compared to cast for patients with a clinically suspected scaphoid fracture with normal initial radiographs. Our hypothesis is that patients with a clinically suspected scaphoid fracture…
ID
Source
Brief title
Condition
- Fractures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Difference between groups in change between baseline and 3 months follow-up in
functional outcome.
Secondary outcome
Besides, differences in medical consumption, pain medication use, adverse
events, absence from work or decreased productivity, and patient costs, will be
assessed.
Background summary
The usual care is that patients with clinical complaints of the wrist suspected
for a fracture of scaphoid, without radiographic signs of a fracture, will be
treated with cast. Although all suspected scaphoid fractures are immobilized in
cast, only ten percent of patients appears to have a true scaphoid fracture
during follow-up. Therefore 90%of patients are unnecessary immobilized in cast.
A bandage seems to be a good alternative.
Study objective
To evaluate the cost-effectiveness of a supportive bandage compared to cast for
patients with a clinically suspected scaphoid fracture with normal initial
radiographs.
Our hypothesis is that patients with a clinically suspected scaphoid fracture
with normal initial radiographs treated with a bandage, have minimally equal
functional outcome after 3 months compared to cast, but with lower costs.
Study design
Open-labeled multicenter RCT (non-inferiority). Comparison of
cost-effectiveness of supportive bandage versus cast as treatment for patients
with a clinically suspected scaphoid fracture with normal initial radiographs.
Intervention
INTERVENTION
Supportive bandage for 3 days, and patients are allowed to move the wrist
driven by the amount of pain.
USUAL CARE /COMPARISON
Below-elbow cast for 2 weeks.
Study burden and risks
The burden is primarily time (visit of outpatient clinic, and to fill in
questionnaires). There is no direct benefit from participation or group
relatedness.
's Gravendijksewal 230
Rotterdam 3015 CE
NL
's Gravendijksewal 230
Rotterdam 3015 CE
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all
of the following criteria: patients aged 18 year or older, with clinically
suspected scaphoid fracture without radiological sign of a fracture, injury
less than 48 hours ago, and willing to comply with the study protocol.
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded
from participation in this study: concomitant injuries to the ipsilateral
extremity and inability to complete study forms due to any mental status or
insufficient command of the Dutch or English language.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL62620.078.17 |
| OMON | NL-OMON20183 |