No registrations found.
ID
Source
Brief title
Health condition
Ankle/Enkel
Fracture/Fractuur
Syndesmotic screw/Syndesmose schroef
Implant removal/ Verwijderen osteosynthesemateriaal
Routine removal/ Routinematig verwijderen schroef
Removal on demand/ op indicatie verwijderen schroef
Functional outcome/ functioneel herstel
Cost-effectiveness/ kosteneffectiviteit
Sponsors and support
Intervention
Outcome measures
Primary outcome
OMAS
Secondary outcome
• Functional outcome through the American Orthopedic Foot and Ankle Score (AOFAS)
• Pain though the Visual analog scale (VAS-score)
• Range-of-motion
• Surgical complications (such as wound infections)
• Recurrent syndesmotic diastasis
• Quality of life though the EQ-5D-5L
• Health care consumption through the iMCQ
• Loss of productivity through the iPCQ
Background summary
The RODEO trial investigated the difference in functional outcome between routine and on demand removal of the syndesmotic screw and found that on demand removal was non-inferior to routine removal.
Study objective
The outcome in patients with removal on demand is not inferior to the outcome in patients with routine removal. By omitting routine removal a reduction in costs will be achieved
Study design
3, 6 and 12 months postoperatively
Intervention
We will investigate a removal on demand strategy regarding the syndesmotic screw. This means that patients, in whom a syndesmotic screw has been placed, will not be scheduled for screw removal unless the screw becomes symptomatic. Examples of symptomatic hardware are restricted range-of-motion and prominent screws.
Inclusion criteria
• Over 17 years of age
• A syndesmotic screw for an instable ankle fracture
• Syndesmotic screw placed within two weeks of the trauma
• Being in such condition that one is able to possibly undergo a second procedure
Exclusion criteria
• Patients treated with another device than a syndesmotic screw
• ISS score > 15
• Injuries to the ipsi- and contralateral side which might hamper rehabilitation
• Other medical conditions which hamper physical rehabilitation
• Incomprehensive understanding of the Dutch language
Design
Recruitment
IPD sharing statement
Plan description
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5810 |
| NTR-old | NTR5965 |
| CCMO | NL58539.018.16 |
| OMON | NL-OMON47890 |