Overnight and In-house 3D-printed Patient-specific Casts for Non-operative Treatment of Distal Radius Fractures

NCT05346926 | Completed DMC

• 1 other identifier: 2019-01644
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this prospective randomized trial is the acquisition and evaluation of data to assess the relevance, feasibility and safety of forearm casts based on 3D-printing technology in the nonoperative treatment of distal radius fractures.

Conditions

Radius Fracture Distal

Keywords

Distal Radius Fracture, 3D-Printing

Outcome Measures

Primary Outcomes (2)

• Score of modified patient satisfaction questionnaire

  quantified with questionnaire (0-12, 0=worst result)

  1 year

• Score of clinical effectiveness questionnaire

  quantified with questionnaire (0-12, 0=worst result)

  1 year

Secondary Outcomes (5)

• Fracture healing

  1 year

• Score on Visual Analogue Pain Scale

  1 year

• Amount of range of motion in degrees

  1 year

• Amount of grip strength in (N/kg)

  1 year

• Score of Disabilities of Arm, Shoulder and Hand

  1 year

Study Arms (2)

3D-printed cast

EXPERIMENTAL

Treatment of distal radius fracture with 3D-printed forearm cast.

Device: 3D-printed cast

Conventional cast

ACTIVE COMPARATOR

Treatment of distal radius fracture with conventional plaster cast.

Device: Conventional cast

Interventions

3D-printed cast DEVICE

The 3D-printed casts are produced using 3D print technology based on software by Belgian software company: The patient's forearm is scanned with a tablet (duration: approx. 5 min), whereupon the cast is printed overnight according to the scan (duration: approx. 4h) and adjusted to the patient during the next appointment.

3D-printed cast

Conventional cast DEVICE

A conventional plaster cast is applied for treatment of the distal radius fracture.

Conventional cast

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed Consent as documented by signature (Appendix Informed Consent Form)
• Undisplaced or minimally displace distal radius fractures

You may not qualify if:

• Age \< 18yrs.
• Dorsal dislocation (dp angle) \>20°
• Palmar dislocation
• Ad latus dislocation
• Radio-/ulnar angulation in the coronary plane
• Symptoms of neurologic affection (Median nerve)
• Bilateral fractures
• Previous ipsilateral distal radius fracture
• The patient is unable to give informed consent due to physical or mental impairment
• The patient is unavailable for follow-up examinations (foreign country, Polytrauma, etc)
• The patient is under legal custodianship
• C2- or Drug-abuse or expected incompliance
• Hypersensitivity/Allergy to one or more components of the used casts
• Pregnancy/Intention to become pregnant during the course of the study

Sponsors & Collaborators

• Alissa Gubeli: lead
• Spentys: collaborator

Study Sites (1)

Kantonsspital Baselland

Bruderholz, Basel-Landschaft, 4101, Switzerland

Location

MeSH Terms

Conditions

Wrist Fractures

Condition Hierarchy (Ancestors)

Wrist Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone

Study Officials

• Philipp Honigmann, PD Dr. med.

  Cantonal Hosptal, Baselland

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Junior Consultant Hand Surgery

Study Record Dates

• First Submitted: April 17, 2022
• First Posted: April 26, 2022
• Study Start: March 1, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: April 26, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)