Nonoperative treatment of dorsally dislocated distal radius fractures in adults with an individualized 3D printed brace; a tolerability study in healthy volunteers and patients

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.

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.

Two consecutive prospective case series.

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.

Part 1: A first visit for the scanning procedure of the contralateral wrist and
a second visit to apply the brace. Participants will receive a telephone call
on day one and three to inquire about pain or other problems. In case of
problems, they will visit the outpatient department. If preferred, the
investigator may also visit them at home. Skin inspection will take place after
removal of the brace (1 week; or earlier if necessary due to problems). On day
one, three, and after removal of the brace, participants will be asked to
complete a VAS for wearing comfort of the brace and pain during sleep and
specific activities.

Part 2: At presentation to the Emergency Department the contralateral wrist is
scanned. A second visit at the first working day for the application of the
brace. Follow-up data will be collected at one week, two weeks, and after
removal of the brace at five weeks (or earlier if necessary due to problems).
At the follow-up visits, patients will be asked to complete a VAS for wearing
comfort of the brace and pain during sleep and specific activities.