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

NCT ID: NCT05902442

Last Updated: 2023-06-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-01
• Study Completion Date: 2023-12-31

Brief Summary

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.

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.

Conditions

Distal Radius Fractures

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

3DxSPLINT

Group Type: EXPERIMENTAL

3DxSPLINT

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Radboud University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

V.M.A. Stirler, dr.

Role: PRINCIPAL_INVESTIGATOR

Department of Trauma Surgery, Radboud University Medical Centre, Nijmegen, the Netherlands.

Central Contacts

V.M.A. Stirler, dr.

Role: CONTACT

vincent.stirler@radboudumc.nl

24361712 ext. +31

L.A. van Ginkel

Role: CONTACT

laura.vanginkel@radboudumc.nl

Other Identifiers

NL83500.091.22

Identifier Type: -

Identifier Source: org_study_id