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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Radius Fracture Distal

Intervention / Treatment
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* Device: 3D-printed cast
* Device: Conventional cast


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed Consent as documented by signature (Appendix Informed Consent Form) Undisplaced or minimally displace distal radius fractures Exclusion Criteria: Age < 18yrs. Dorsal dislocation (dp angle) >20° Palmar dislocation Ad latus dislocation Radio-/ulnar angulation in the coronary plane Symptoms of neurologic affection (Median nerve) Bilateral fractures Previous ipsilateral distal radius fracture The patient is unable to give informed consent due to physical or mental impairment The patient is unavailable for follow-up examinations (foreign country, Polytrauma, etc) The patient is under legal custodianship C2- or Drug-abuse or expected incompliance Hypersensitivity/Allergy to one or more components of the used casts Pregnancy/Intention to become pregnant during the course of the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Distal Radius Fracture, 3D-Printing