NCT05902442

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 5, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 15, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

October 1, 2023

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

June 15, 2023

Status Verified

June 1, 2023

Enrollment Period

Same day

First QC Date

June 5, 2023

Last Update Submit

June 5, 2023

Conditions

Distal Radius Fractures

Keywords

3D printing technologyCastSplintImmobilizationNonoperativePatient specificRadius Fracture

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (5)

  • PRWE

    Approximately, one week, three to five weeks and 3 months post injury.

  • Complications

    three months post injury.

  • Union rate

    One week to three months post injury

  • Safety outcomes

    one week to three months post injury

  • Barriers to implementation

    one week to three months post injury

Other Outcomes (1)

  • Baseline characteristics

    Directly after admission

Study Arms (1)

3DxSPLINT

EXPERIMENTAL
Device: 3DxSPLINT

Interventions

3DxSPLINTDEVICE

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.

3DxSPLINT

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Wrist FracturesRadius Fractures

Condition Hierarchy (Ancestors)

Wrist InjuriesArm InjuriesWounds and InjuriesFractures, BoneForearm Injuries

Study Officials

  • V.M.A. Stirler, dr.

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

V.M.A. Stirler, dr.

CONTACT

24361712vincent.stirler@radboudumc.nl

L.A. van Ginkel

CONTACT

laura.vanginkel@radboudumc.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 5, 2023

First Posted

June 15, 2023

Study Start

October 1, 2023

Primary Completion

October 1, 2023

Study Completion

December 31, 2023

Last Updated

June 15, 2023

Record last verified: 2023-06