Radius Distal Fracture
Conditions
Keywords
elderly, intra articular, RCT
Brief summary
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.
Detailed description
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. 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 study parameters: the primary outcome will be evaluated after 1 year with the Patient-Rated Wrist Evaluation score (PRWE). Secondary outcomes comprise other patient reported outcome measures (PROM) including the Disability of the Arm, Shoulder and Hand (DASH), Quality of life (EQ-5D) and Pain Catastrophizing Scale (PCS). Further outcome measurements comprise a costs evaluation questionnaire, range of motion (ROM), grip strength, radiographic parameters and Complications.
Interventions
PROCEDURESurgery (Open Reduction Internal Fixation)
Either volar of dorsal plating or both
PROCEDURECast treatment
Hospitals may use their preferred protocol
Sponsors
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Maasstad Hospital
Deventer Ziekenhuis
JointResearch
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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 * Fit for surgery * Mentally competent * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PRWE | 12 months | Patient-Rated Wrist Evaluation score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| DASH | 12 months | Disability of the Arm, Shoulder and Hand |
| EQ/5D | 12 months | Quality of life |
| PCS | 12 months | Pain Catastrophizing Scale |
Other
| Measure | Time frame | Description |
|---|---|---|
| ROM | 12 months | range of motion |
| grip strength | 12 months | grip strength of both wrists |
| Radiographic parameters | 6 months | Radial inclination, volar/dorsal tilt, ulnar variance, gap, step off and radial length |
| Complications | 12 months | Complications of either treatment arm |
Countries
Netherlands
Outcome results
None listed