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

Radius Fracture Distal Clinical Trial

— 3D-cast  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05346926
• Other study ID #: 2019-01644
• Status: Completed
• Phase: N/A
• Start date: March 1, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: April 2022
• Source: Kantonsspital Baselland Bruderholz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Radius Fracture Distal
• Radius Fractures

Intervention

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

Locations

Country	Name	City	State
Switzerland	Kantonsspital Baselland	Bruderholz	Baselland

Sponsors (2)

Lead Sponsor	Collaborator
Alissa Gubeli	Spentys

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Score of modified patient satisfaction questionnaire	quantified with questionnaire (0-12, 0=worst result)	1 year
Primary	Score of clinical effectiveness questionnaire	quantified with questionnaire (0-12, 0=worst result)	1 year
Secondary	Fracture healing	assessed with X-ray pictures taken during the follow-up, consolidation signs	1 year
Secondary	Score on Visual Analogue Pain Scale	assessed using the Visual Analogue Pain Scale (0-10, 0=best result, no pain)	1 year
Secondary	Amount of range of motion in degrees	assessed/measured by the physician with a goniometer (°, 0-360°)	1 year
Secondary	Amount of grip strength in (N/kg)	assessed with a dynamometer (N/kg, the lower the weaker)	1 year
Secondary	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