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Nonoperative Treatment of Dorsally Dislocated Distal Radius Fractures in Adults With an Individualized 3D Printed Brace.

NCT03848702 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2019-02-22

No results posted yet for this study

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.

Conditions

  • Dorsal Displacement

Interventions

DEVICE

Distal radius fracture brace

The distal radius fracture brace is constructed from biocompatible materials (like polylactic acid; PLA) and the skin is protected by commercially available and approved waterproof padding (like Aquacast®). The major brace components are connected and reinforced with carbon rods and plastic bolt-nut connections. PLA is extensively used, for example in surgical implants, but also as biological alternative for plastics. Aquacast® is approved and used as waterproof padding in swim plaster. The biomechanical function of the distal radius brace has been tested successfully in an ex vivo setting (results to be published). The DRFB includes the distal forearm, wrist an base of the hand. The thumb and fingers are free and the DRFB provides more movement than classical casting.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-07-01
Primary Completion
2018-06-01
Completion
2018-07-01

Countries

  • Netherlands

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03848702 on ClinicalTrials.gov