Clinical trial NCT05346926: Overnight and In-house 3D-printed Patient-specific Casts for Non-operative Treatment of Distal Radius Fractures
Official title: Overnight and In-house 3D-printed Patient-specific Casts for Non-operative Treatment of Distal Radius Fractures - a Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Radius Fracture Distal
Keywords: Distal Radius Fracture, 3D-Printing
Lead sponsor: Kantonsspital Baselland Bruderholz
Sponsor class: OTHER
Collaborators: name: Spentys
First posted: 2022-04-26
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Score of modified patient satisfaction questionnaire
timeFrame: 1 year
measure: Score of clinical effectiveness questionnaire
timeFrame: 1 year
Secondary outcomes:
measure: Fracture healing
timeFrame: 1 year
measure: Score on Visual Analogue Pain Scale
timeFrame: 1 year
measure: Amount of range of motion in degrees
timeFrame: 1 year
measure: Amount of grip strength in (N/kg)
timeFrame: 1 year
measure: Score of Disabilities of Arm, Shoulder and Hand
timeFrame: 1 year
Other outcomes:
Locations:
city: Bruderholz
country: Switzerland
facility: Kantonsspital Baselland
state: Baselland
Study officials:
affiliation: Cantonal Hosptal, Baselland
name: Philipp Honigmann, PD Dr. med.
role: STUDY_DIRECTOR
References: