Nonoperative Treatment of Dorsally Dislocated Distal Radius Fractures in Adults With an Individua… (NCT03848702) | Clinical Trial Compass
CompletedNot Applicable
Nonoperative Treatment of Dorsally Dislocated Distal Radius Fractures in Adults With an Individualized 3D Printed Brace.
Netherlands15 participantsStarted 2017-07-01
Plain-language summary
Study design: Two consecutive prospective case series. Study population: Part 1 will enroll 10 healthy volunteers (50 years or older). Part 2 will enroll 10 elderly patients (50 years or older) with a dorsally displaced distal radius fracture (AO type 23-A-C) that is acceptably reduced. In both parts, participants should have no restrictions in activities of daily living pre-fracture and no evident anatomical difference between both wrists.
Intervention:
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 (instead of a plaster cast).
Main study parameters/endpoints: In parts 1 and 2, the primary outcome measure will be a Visual Analog Scale (VAS) score for wearing comfort. Secondary outcome measures are the occurrence of fracture redislocation (part 2 only), pain (VAS), inconvenience during NL61002.078.17 / DRFB-Tolerability Distal Radius Fracture Brace Tolerability Version number: 1.1, d.d. April 24, 2017 8 of 34 activities of daily living (Katz Index), and adverse reactions like pain, skin pressure, skin irritation/redness, sensibility issues, or device-related problems.
Who can participate
Age range50 Years
SexALL
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Inclusion criteria
✓. Age 50 years or older
✓. Healthy volunteer without distal radius fracture
✓. No restrictions in activities of daily living prior to enrolment\*
✓. Signed informed consent by participant \* Participant should exercises complete self-control over urination and defecation, but use of incontinence material is allowed.
✓. 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)
✓. No restrictions in activities of daily living pre-fracture\*
✓. Signed informed consent by patient
Exclusion criteria
✕. Preexisting anatomical deviation of the ipsi- or contralateral wrist
✕. Conditions that affect function of the wrist or hand
What they're measuring
1
VAS score
Timeframe: Day 1, day 3 and 7 for part 1. Week 1, week 2 and week 5 for part 2