Cast treatment is not inferior to surgical open reduction and internal fixation in terms of patient related outcome measurements.
ID
Bron
Verkorte titel
Aandoening
Distal radius fracture elderly
Ondersteuning
SEENEZ project
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
• Wrist function as reported by the patient (Patient-Rated Wrist Evaluation score) (PRWE)) 1 year after trauma
Achtergrond van het onderzoek
Rationale: 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).
Doel van het onderzoek
Cast treatment is not inferior to surgical open reduction and internal fixation in terms of patient related outcome measurements.
Onderzoeksopzet
T1: 1 week
T2: 3 weeks
T3: 6 weeks
T4: 3 months
T5: 6 months
T6: 9 months
T7: 12 months
Onderzoeksproduct en/of interventie
Surgery: open reduction internal fixation by volar (and possibly dorsal plating).
Conservative: cast treatment
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
• >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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
• 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
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL6201 |
| NTR-old | NTR6365 |
| Ander register | NL56858.100.16 : NCT03009890 |