No registrations found.
ID
Source
Brief title
Health condition
Distal radius fracture elderly
Sponsors and support
SEENEZ project
Intervention
Outcome measures
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)
Background summary
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).
Study objective
Cast treatment is not inferior to surgical open reduction and internal fixation in terms of patient related outcome measurements.
Study design
T1: 1 week
T2: 3 weeks
T3: 6 weeks
T4: 3 months
T5: 6 months
T6: 9 months
T7: 12 months
Intervention
Surgery: open reduction internal fixation by volar (and possibly dorsal plating).
Conservative: cast treatment
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
Design
Recruitment
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 |
|---|---|
| NTR-new | NL6201 |
| NTR-old | NTR6365 |
| Other | NL56858.100.16 : NCT03009890 |