Radius Fracture Distal3D-castNCT05346926
Overnight and In-house 3D-printed Patient-specific Casts for Non-operative Treatment of Distal Radius Fractures
A study testing 3D-printed cast and Conventional cast in people with Radius Fracture Distal, run by Alissa Gubeli at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radius Fracture Distal
- What is being tested?
- 3D-printed cast and Conventional cast
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Mar 2020to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed Consent as documented by signature (Appendix Informed Consent Form)
- Undisplaced or minimally displace distal radius fractures
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Kantonsspital Baselland
Bruderholz, Basel-Landschaft, 4101
About this study
Official title: Overnight and In-house 3D-printed Patient-specific Casts for Non-operative Treatment of Distal Radius Fractures - a Prospective Randomized Trial
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.
Read the 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.
- Conditions
- Radius Fracture Distal
- Being tested
- 3D-printed cast, Conventional cast
- Keywords
- Distal Radius Fracture, 3D-Printing
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D-printed castDevice
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 castDevice
A conventional plaster cast is applied for treatment of the distal radius fracture.
| Study group | Role | What they receive |
|---|---|---|
| 3D-printed cast | Experimental | Treatment of distal radius fracture with 3D-printed forearm cast. Receives: Device: 3D-printed cast |
| Conventional cast | Active comparator | Treatment of distal radius fracture with conventional plaster cast. Receives: Device: Conventional cast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score of modified patient satisfaction questionnaire
quantified with questionnaire (0-12, 0=worst result)
Measured: 1 year
Score of clinical effectiveness questionnaire
quantified with questionnaire (0-12, 0=worst result)
Measured: 1 year
Secondary outcomes (5)
Fracture healing
assessed with X-ray pictures taken during the follow-up, consolidation signs
Measured: 1 year
Score on Visual Analogue Pain Scale
assessed using the Visual Analogue Pain Scale (0-10, 0=best result, no pain)
Measured: 1 year
Amount of range of motion in degrees
assessed/measured by the physician with a goniometer (°, 0-360°)
Measured: 1 year
Amount of grip strength in (N/kg)
assessed with a dynamometer (N/kg, the lower the weaker)
Measured: 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)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2022
- Study start1 Mar 2020
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radius Fracture DistalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alissa Gubeli
- Sponsor type
- University, hospital or other
- Collaborators
- Spentys
- Responsible party
- Sponsor-investigator, Alissa Gubeli, Kantonsspital Baselland Bruderholz
- Investigators
- Philipp Honigmann, PD Dr. med., Study director, Cantonal Hospital, Baselland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05346926
- Sponsor's protocol ID
- 2019-01644
- Other IDs
- 2019
- Acronym
- 3D-cast
- Status last verified
- Apr 2022
- First submitted
- 17 Apr 2022
- Last updated
- 26 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Overnight and In-house 3D-printed Patient-specific Casts for Non-operative Treatment of Distal Radius Fractures - a Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT05346926
- Acronym / sponsor ID
- 3D-cast / 2019-01644
- Conditions
- Radius Fracture Distal
- Keywords
- Distal Radius Fracture, 3D-Printing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Alissa GubeliUniversity, hospital or other
- Collaborators
- Spentys
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 26 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3D-printed cast | Experimental | Device: 3D-printed castTreatment of distal radius fracture with 3D-printed forearm cast. |
| Conventional cast | Active comparator | Device: Conventional castTreatment of distal radius fracture with conventional plaster cast. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Informed Consent as documented by signature (Appendix Informed Consent Form)
- Undisplaced or minimally displace distal radius fractures
Key exclusion criteria (14 listed)
- Age < 18yrs.
- Dorsal dislocation (dp angle) >20°
- Palmar dislocation
- Ad latus dislocation
- Radio-/ulnar angulation in the coronary plane
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3D-printed castThe 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. | Device | 3D-printed cast |
| Conventional castA conventional plaster cast is applied for treatment of the distal radius fracture. | Device | Conventional cast |
Primary outcome
Score of modified patient satisfaction questionnaire
Time frame: 1 year
quantified with questionnaire (0-12, 0=worst result)
Score of clinical effectiveness questionnaire
Time frame: 1 year
quantified with questionnaire (0-12, 0=worst result)
5 secondary outcomes
Fracture healing
Time frame: 1 year
Score on Visual Analogue Pain Scale
Time frame: 1 year
Amount of range of motion in degrees
Time frame: 1 year
Amount of grip strength in (N/kg)
Time frame: 1 year
Score of Disabilities of Arm, Shoulder and Hand
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philipp Honigmann, PD Dr. med. study director
Cantonal Hospital, Baselland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D-printed cast and Conventional cast in people with Radius Fracture Distal, run by Alissa Gubeli at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score of modified patient satisfaction questionnaire (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2022.