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van CCT (UK)

van CCT (UK)

Gips vergeleken met opereren voor een gebroken pols, wat geeft een beter resultaat bij ouderen?

- candidate number26533
- NTR NumberNTR6365
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR25-jan-2017
- Secondary IDsNCT03009890 NL56858.100.16
- Public TitleGips vergeleken met opereren voor een gebroken pols, wat geeft een beter resultaat bij ouderen?
- Scientific TitleThe effectiveness of surgery versus casting for elderly patients with Displaced distal intra-Articular Radius fractures. A randomized controlled Trial.
- hypothesisCast treatment is not inferior to surgical open reduction and internal fixation in terms of patient related outcome measurements.
- Healt Condition(s) or Problem(s) studiedDistal radius fracture
- Inclusion criteria >65 years at time of trauma
Intra-articular distal radius fracture (AO type C*)
One or more of the following fracture characteristics within 3 weeks post-trauma (including secondary dislocation):
≤15 inclination
<5 mm radial length
>15 dorsal tilt
>20 volar tilt
intra-articular gap or step-off >2 mm
< 3 weeks post trauma
Living independent at home (e.g. not in a retirement home)
Fit for surgery
Mentally competent
The patient must be able to fully understand the consequences of participation. This includes that the patient must be aware of the burden that the research project provides, the possible complications in both treatment arms and the possibility to not participate in the trial.
Furthermore he or she must be able to fill out the questionnaires.
Dutch fluency and literacy
Informed consent
- Exclusion criteria Open fractures
Neurovascular damage
Multiple-trauma patients (ISS >16)
Other fractures in the injured extremity other than ulnar styloid process fractures
Contralateral fracture of the forearm
- mec approval receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-feb-2017
- planned closingdate1-aug-2020
- Target number of participants154
- InterventionsSurgery: open reduction internal fixation by volar (and possibly dorsal plating).
Conservative: cast treatment
- Primary outcome Wrist function as reported by the patient (Patient-Rated Wrist Evaluation score) (PRWE)) 1 year after trauma
- Secondary outcome Wrist function as reported by the patient (Disabilities of the Arm, Shoulder and Hand (DASH))
Quality of life as reported by the patient (EQ-5D)
Patient reported pain catastrophizing (Pain Catastrophizing Scale (PCS))
Costs evaluation questionnaire
ROM (range of motion)
- TimepointsT1: 1 week
T2: 3 weeks
T3: 6 weeks
T4: 3 months
T5: 6 months
T6: 9 months
T7: 12 months
- Trial web
- statusplanned
- Sponsor/Initiator Onze Lieve Vrouwe Gasthuis (OLVG) Locatie Oosterpark
- Funding
(Source(s) of Monetary or Material Support)
ZonMw Doelmatigheid, SEENEZ project
- Publications-
- Brief summaryRationale: there is no consensus about the optimal treatment of displaced intra-articular distal radius fractures in elderly patients. To ensure optimal functional outcome there is a tendency to operate. However, there is no evidence that supports the surgical treatment of patients aged 65 years or older and in the absence of clinical trials it stays unclear how elderly patients with intra-articular fractures should be treated.

Objective: to compare the functional outcome after open reduction and internal fixation with non-operative cast treatment for elderly patients with displaced intra-articular distal radius fractures.

Study design: multi-center randomized controlled trial with a non-inferiority design. Economic evaluation alongside a randomized controlled multi-center trial.

Study population: all consecutive patients aged between 65 years and older with displaced intra-articular (AO Type C) distal radius fractures, with a not acceptable reduction within 3 weeks following trauma.
Intervention: patients will be randomized between open reduction and internal fixation (intervention group) and plaster immobilization (control group).
- Main changes (audit trail)
- RECORD25-jan-2017 - 19-jun-2017

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