Dorsal Displacement Clinical Trial
Official title:
Nonoperative Treatment of Dorsally Dislocated Distal Radius Fractures in Adults With an Individualized 3D Printed Brace; a Tolerability Study in Healthy Volunteers and Patients (DRFB)
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.
Rationale: Each year, approximately 34,500 adults in The Netherlands sustain a fracture of
the distal radius (wrist fracture). Incidence peaks in the elderly. The currently preferred
treatment is closed reduction and nonoperative treatment by immobilization in a plaster cast
for 4-6 weeks. Surgery is only performed if closed reduction fails or redislocation occurs.
Plaster immobilization is inconvenient and interferes with daily activities. More
importantly, standard nonoperative treatment often fails; in 40-60% of the fractures,
redislocation requires surgery. Surgical treatment is about 9 times more expensive than
nonoperative treatment and not without risks. This project aims to develop an innovative
nonoperative treatment option. The central idea is to produce a 3D-printed brace for the
fractured wrist using a mirrored CT-scan of the contralateral, unfractured wrist as a model.
This innovative approach has the advantage that it does not depend on surgery and provides a
better and potentially more durable positioning than the currently applied plaster cast. We
expect that redislocation will occur less frequently, so surgery may be avoided. In contrast
to a traditional plaster cast, the newly developed brace is water resistant/repellant,
lighter, and enables movement of the hand. It enables daily activities and improves
independency in the elderly with a wrist fracture. The treatment has been successfully
evaluated in an ex vivo model. The clinical implementation will follow a step-wise approach.
Objective: Part 1 aims to determine the tolerability of the 3D-printed brace when worn by
healthy volunteers (50 years of order), performing their normal daily activities. In part 2,
the objective is to determine tolerability of the 3D-printed brace in patients (50 years or
older) with an extra-articular distal radius fracture with dorsal displacement, performing
their normal daily activities.
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