To study whether a reduction of the current radiographic follow-up protocol in patients with uncomplicated distal radius and ankle fractures would lead to significant cost savings without compromising quality of care.
ID
Source
Brief title
Condition
- Fractures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Functional status of the affected arm or leg
Secondary outcome
Pain
Quality of life
Self-perceived recovery
Complications
Cost-effectiveness
Background summary
Wrist and ankle fractures are a common and costly health care problem affecting
all age groups. The currently used protocols for timing of radiographic
assessment prescribe radiographic imaging at 1, 2, 6 and 12 weeks following
baseline. Published studies have shown, however, that no complications are
missed if imaging is not performed routinely at 6 and 12 weeks and is performed
only on medical grounds.
Study objective
To study whether a reduction of the current radiographic follow-up protocol in
patients with uncomplicated distal radius and ankle fractures would lead to
significant cost savings without compromising quality of care.
Study design
Multicenter randomized controlled non-inferiority trial
Study burden and risks
No risk is involved for the group receiving usual care. In the group without
standard radiographs at 6 and 12 weeks, the risk is considered minimal because
radiographs will be made when clinically indicated. The burden associated with
participation involves the investment of time during routine visits for filling
out a limited number of questionnaires. The study does not involve extra study
visits.
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
Inclusion criteria
- Fracture of the ankle (uni-or bimalleolar fractures /Lauge-Hansen classification SA II, SE II-IV, PA I-IV) or distal radius (AO classification type A-C)
- Adult (>18 years)
- Sufficient understanding of the Dutch language in order to independently complete the follow-up questionnaires
- providing written informed consent
Exclusion criteria
- Psychiatric conditions
- Pathological fracture
- Complicated fractures (Gustillo grade 2 & 3)
- Multi-extremity fractures
- Unable to complete follow-up (e.g. patients living abroad, incarcerated subjects)
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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 |
|---|---|
| Other | NTR4610 |
| CCMO | NL47155.058.14 |