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

Sponsor

Radboud University Medical Center (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05902442

Collaborator

(none)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Distal Radius Fractures	Device: 3DxSPLINT	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

24 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

Oct 1, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

D-QUEST [three to five weeks post injury]
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.
CSD-OPUS [three to five weeks post injury]
The Orthotics and Prosthetics User's Survey on the Satisfaction with Devices.
EQ-5D VAS [three to five weeks post injury]
Rates the overall health of a patient.
Semi structured interview [three to five weeks post injury]
Patient reported outcome measrues related to comfort and satisfaction of the medical aid. Issures discussed:limitations daily life, cosmetic look and local complicaitons.

Secondary Outcome Measures

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

Other Outcome Measures

Baseline characteristics [Directly after admission]
Baseline characteristics as age, gender, fracture classification, side of fracture, dominant arm and activity of daily living are registerd.

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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