A Clinical Comparison of Patient-specific 3D Printed Splints Versus Conventional Splints in the Treatment of Distal Radius Fractures. (3DxSPLINT)

The goal of this clinical trial is to assess patient reported outcome measures of adult patients who are diagnosed with a distal radius fracture and treated with a patient-specific 3D printed splint as compared to a control cohort.

Patients receive routine immobilization procedure with a patient-specific 3D printed splint instead of the use of a conventional forearm splint after one week of conventional immobilization.

The main study parameters are patient reported outcome measures related to comfort and satisfaction of the medical aid. This will be measured qualitatively with a semi-structured interview and quantitively using questionnaires.

Study Overview

• Status: Not yet recruiting
• Conditions: Distal Radius Fractures
• Intervention / Treatment: Device: 3DxSPLINT

Detailed Description

Distal radius fracture (DRF) is a very common injury of the upper extremity. Yearly, over 45,000 patients visit the outpatient clinic with a DRF in the Netherlands. One third of these fractures are non-displaced and two thirds are displaced fractures. The conservative treatment of DRFs includes immobilization of the injured extremity using a conventional forearm cast. These casts do cause all sorts of discomfort during wear and impose life-style restrictions on the wearer. Examples are irritation and itching of the skin, pain from pressure points and inability to shower or swim without a protective sleeve. Emergent three-dimensional (3D) technology enables patient-specific splint design and fabrication. These splints are custom made to accurately fit the individual patient. The material of 3D printed splints is considered lightweight. Moreover, 3D splint design allows an open structure resulting in more ventilation, offering better hygiene and the possibility for wound control. The production of 3D splints can be accomplished with several hardware and software combination. The production process is similar overall and requires several steps. First image data with 3D spatial information of the limb is captured with either a 3D scanner or medical imaging device. The design of the 3D printed splint is further developed using a software application. The 3D splints design data is then exported, and the physical splint is printed using a 3D printer. Depending on material and device characteristics, postprocessing steps are required. The splint may require removal of support, curing and smoothing. If applicable, a closure mechanism is applied.

Currently most implementations of custom made 3D printed splints happen within the framework of case series or feasibility studies. Some previous studies have described on clinical tests from patients with promising results. However, studies are heterogenous in the use of hardware, software, 3D splint design, print materials, fabrication time and costs. Moreover, clinical comparison with conventional interventions remain scare. Therefore, it is challenging to determine the impact of 3D printed splints intervention on the patient with injuries .

The goal of this clinical trial is to assess patient reported outcome measures of adult patients who are diagnosed with a DRF and treated with a patient- specific 3D printed splint as compared to a control cohort. The secondary objectives are:

• To define whether treatment of 3D printed splints of DRF's result in the same clinical outcomes compared to treatment with standard plaster cast .
• To investigate the safety of 3D printed splint treatment.
• To generate hypothesis which individual characteristics might be used to determine which patients can benefit most from 3D printed splint treatment.
• To investigate barriers and facilitators to implementation.

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: V.M.A. Stirler, dr.; Phone Number: +31 24361712; Email: vincent.stirler@radboudumc.nl
• Study Contact Backup: Name: L.A. van Ginkel; Email: laura.vanginkel@radboudumc.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 16 years or older
• Admitted to the emergency department or plaster room with a DRF
• Non-operative treatment with cast immobilization
• Written informed consent
• Patients must be able to follow the study protocol

Exclusion Criteria:

• Operative treatment
• Open fractures
• History of surgically treated wrist fracture on the currently injured side within the last year (≤ 1 year)
• Unable to wear conventional forearm splint due to medical condition, known allergies or other reasons
• (partially) paralysis of the affected arm
• DRF older than two weeks

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 3DxSPLINT	Device: 3DxSPLINT; Routine immobilization procedure with a patient-specific 3D printed splint instead of the use of a conventional forearm splint after one week of conventional immobilization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
D-QUEST	Instrument for measuring client satisfaction with a medical device. D-QUEST is a Dutch version of the Quebec User Evalutation of Satisfaction with assistive Technology.	three to five weeks post injury
CSD-OPUS	The Orthotics and Prosthetics User's Survey on the Satisfaction with Devices.	three to five weeks post injury
EQ-5D VAS	Rates the overall health of a patient.	three to five weeks post injury
Semi structured interview	Patient reported outcome measrues related to comfort and satisfaction of the medical aid. Issures discussed:limitations daily life, cosmetic look and local complicaitons.	three to five weeks post injury

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PRWE	Questionnaire to measure patient rated pain and disability for wrist conditions.	Approximately, one week, three to five weeks and 3 months post injury.
Complications	McKay checklist is used for scoring the complications after distal radius fracture.	three months post injury.
Union rate	Union rate will be measured according to the current clinical standard.	One week to three months post injury
Safety outcomes	Reasons for withdrawal and adverse events (production- and wearing of the 3D printed splints) are registered and evaluated	one week to three months post injury
Barriers to implementation	Acceptance by caregivers and technical problems related to hardware- and software use in the 3D workflow are registered and evaluated.	one week to three months post injury

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Baseline characteristics	Baseline characteristics as age, gender, fracture classification, side of fracture, dominant arm and activity of daily living are registerd.	Directly after admission

Collaborators and Investigators

• Sponsor: Radboud University Medical Center
• Investigators: Principal Investigator: V.M.A. Stirler, dr., Department of Trauma Surgery, Radboud University Medical Centre, Nijmegen, the Netherlands.

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2023
• Primary Completion (Estimated): October 1, 2023
• Study Completion (Estimated): December 31, 2023

Study Registration Dates

• First Submitted: June 5, 2023
• First Submitted That Met QC Criteria: June 5, 2023
• First Posted (Actual): June 15, 2023

Study Record Updates

• Last Update Posted (Actual): June 15, 2023
• Last Update Submitted That Met QC Criteria: June 5, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Immobilization; Patient specific; Splint; 3D printing technology; Radius Fracture; Cast; Nonoperative
• Additional Relevant MeSH Terms: Wounds and Injuries; Arm Injuries; Forearm Injuries; Wrist Injuries; Fractures, Bone; Radius Fractures; Wrist Fractures
• Other Study ID Numbers: NL83500.091.22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No