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

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

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.

Study Overview

• Status: Completed
• Conditions: Radius Fracture Distal
• Intervention / Treatment: Device: 3D-printed cast; Device: Conventional cast

Detailed Description

The study design is planned according to similar studies investigating the treatment of distal radius fractures.

Upon the patient's arrival at the emergency unit, the distal radius fracture is examined following the same scheme as before. The wrist is x-rayed in two planes. If there is a distal radius fracture and none of the exclusion criteria apply, the patient is included in the study after giving their consent in writing. The patients are then assigned to the "conventional cast" group (Group A) or the "3D print cast" group (Group B) in randomized trial, either immediately during the emergency consultation or within a week during hand surgery consultation hours. For initial immobilization, a thermoplastic cast splint is used as before. Depending on the randomization, the cast is changed to a Scotchcast cast (Group A) or a 3D printed cast (Group B). Further treatment of both groups occurs based on the same algorithm as before (see below).

The cast for Group B are produced using 3D print technology based on software by a Belgian company, our collaborators: 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.

The patients are examined after 1, 6, 12, 26 and 52 weeks in the outpatient clinic. Follow up x rays, patient satisfaction and clinical efficacy questionnaires and clinical examinations are conducted.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Baselland
    • Bruderholz, Baselland, Switzerland, 4101
      • Kantonsspital Baselland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 3D-printed cast; Treatment of distal radius fracture with 3D-printed forearm cast.	Device: 3D-printed cast; 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.
Active Comparator: Conventional cast; Treatment of distal radius fracture with conventional plaster cast.	Device: Conventional cast; A conventional plaster cast is applied for treatment of the distal radius fracture.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fracture healing	assessed with X-ray pictures taken during the follow-up, consolidation signs	1 year
Score on Visual Analogue Pain Scale	assessed using the Visual Analogue Pain Scale (0-10, 0=best result, no pain)	1 year
Amount of range of motion in degrees	assessed/measured by the physician with a goniometer (°, 0-360°)	1 year
Amount of grip strength in (N/kg)	assessed with a dynamometer (N/kg, the lower the weaker)	1 year
Score of Disabilities of Arm, Shoulder and Hand	assessed with Disabilities of Arm, Shoulder and Hand score (0-100, 0=best result, no impairment)	1 year

Collaborators and Investigators

• Sponsor: Alissa Gubeli
• Collaborators: Spentys
• Investigators: Study Director: Philipp Honigmann, PD Dr. med., Kantonsspital Baselland

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2020
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: April 17, 2022
• First Submitted That Met QC Criteria: April 23, 2022
• First Posted (Actual): April 26, 2022

Study Record Updates

• Last Update Posted (Actual): April 26, 2022
• Last Update Submitted That Met QC Criteria: April 23, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Distal Radius Fracture, 3D-Printing
• Additional Relevant MeSH Terms: Wounds and Injuries; Arm Injuries; Forearm Injuries; Fractures, Bone; Radius Fractures; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Cysteine Proteinase Inhibitors; Calpastatin
• Other Study ID Numbers: 2019-01644

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No