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
ID
Bron
Verkorte titel
Aandoening
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
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
OMAS
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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
Onderzoeksopzet
3, 6 and 12 months postoperatively
Onderzoeksproduct en/of interventie
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.
Algemeen / deelnemers
Wetenschappers
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
• 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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
• 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
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Toelichting
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL5810 |
| NTR-old | NTR5965 |
| CCMO | NL58539.018.16 |
| OMON | NL-OMON47890 |