Radius Fracture Distal
Conditions
Keywords
Distal Radius Fracture, 3D-Printing
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.
Interventions
DEVICE3D-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.
DEVICEConventional cast
A conventional plaster cast is applied for treatment of the distal radius fracture.
Sponsors
Spentys
Alissa Gubeli
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Score of modified patient satisfaction questionnaire | 1 year | quantified with questionnaire (0-12, 0=worst result) |
| Score of clinical effectiveness questionnaire | 1 year | quantified with questionnaire (0-12, 0=worst result) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Amount of range of motion in degrees | 1 year | assessed/measured by the physician with a goniometer (°, 0-360°) |
| Fracture healing | 1 year | assessed with X-ray pictures taken during the follow-up, consolidation signs |
| 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) |
| Amount of grip strength in (N/kg) | 1 year | assessed with a dynamometer (N/kg, the lower the weaker) |
| Score on Visual Analogue Pain Scale | 1 year | assessed using the Visual Analogue Pain Scale (0-10, 0=best result, no pain) |
Countries
Switzerland
Outcome results
None listed