Distal radius fracture
Conditions
Interventions
Part 1: Participants will wear the brace continuously for one week.
Part 2: Participants will wear the brace as treatment of the fracture for five
weeks.
Distal radius fracture
Fracture
Treatment
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: Part 1: 1. Age 50 years or older 2. Healthy volunteer without distal radius fracture 3. No restrictions in activities of daily living prior to enrolment* 4. Signed informed consent by participant;Part 2: 1. Patients (50 years or older) with an acute**, unilateral distal radius fracture with dorsal displacement (AO type 23-A, B, or C) that is acceptably reduced (by simple closed reduction with vertical longitudinal traction) 2. No restrictions in activities of daily living pre-fracture* 3. Signed informed consent by patient;* Participant should exercises complete self-control over urination and defecation, but use of incontinence material is allowed. ** Patients should report to the Emergency Department within 48h post-trauma.
Exclusion criteria
Exclusion criteria: Part 1: 1. Preexisting anatomical deviation of the ipsi- or contralateral wrist 2. Conditions that affect function of the wrist or hand 3. Insufficient comprehension of the Dutch language to understand the study documents 4. Participant unwilling or unable to comply with the study protocol and follow-up visit schedule 5. Known allergy for brace material (PLA or alternative);Part 2: 1. Preexisting anatomical deviation of the ipsi- or contralateral wrist 2. Additional traumatic injuries that affect treatment, rehabilitation, or function of the affected hand 3. Pathological, recurrent, or open fracture 4. Impaired wrist function pre-trauma at either wrist (e.g., arthrosis, rheumatoid disorder, or neurological disorder) 5. Bone disorder that may impair bone healing, excluding osteoporosis 6. Patient unwilling or unable to comply with the treatment protocol and follow-up visit schedule 7. Insufficient comprehension of the Dutch language to understand the study documents 8. Known allergy for brace material (PLA or alternative).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visual Analog Scale (VAS) score for wearing comfort. | — |
Secondary
| Measure | Time frame |
|---|---|
| Fracture redislocation (part 2 only) Pain (VAS) Inconvenience during activities of daily living (Katz Index) Adverse reactions like pain, skin pressure, skin irritation/redness, sensibility issues, or device-related problems. | — |
Countries
The Netherlands
Outcome results
None listed