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

Not Applicable

Completed

• Conditions: Radius Fracture Distal
• Interventions: Device: Conventional cast; Device: 3D-printed cast

• Registration Number: NCT05346926
• Lead Sponsor: Alissa Gubeli

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.

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 Timeline

• Study Start: 2020-03-01
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Status Verified: 2022-04
• Study First Submitted: 2022-04-17
• Study First Submitted QC: 2022-04-23
• Last Update Submitted: 2022-04-23
• Study First Posted: 2022-04-26
• Last Update Posted: 2022-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional cast	Conventional cast	Treatment of distal radius fracture with conventional plaster cast.
3D-printed cast	3D-printed cast	Treatment of distal radius fracture with 3D-printed forearm cast.

Primary Outcome Measures

Name	Time	Method
Score of clinical effectiveness questionnaire	1 year	quantified with questionnaire (0-12, 0=worst result)
Score of modified patient satisfaction questionnaire	1 year	quantified with questionnaire (0-12, 0=worst result)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Kantonsspital Baselland; 🇨🇭 Bruderholz, Baselland, Switzerland