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

NCT05902442 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2023-06-15

No results posted yet for this study

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.

Conditions

  • Distal Radius Fractures

Interventions

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.

Sponsors & Collaborators

  • Radboud University Medical Center

    lead OTHER

Principal Investigators

  • V.M.A. Stirler, dr. · Department of Trauma Surgery, Radboud University Medical Centre, Nijmegen, the Netherlands.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-01
Primary Completion
2023-10-01
Completion
2023-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05902442 on ClinicalTrials.gov