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Completed

NCT Number: NCT04306796

3D Printed Made to Measure Splints for Hand Patients

This study aims to evaluate the feasibility and possible benefits of 3D-printed made to measure splints for postoperative or post-traumatic treatment in hand surgical patients (intervention group) in comparison to thermoplastic splints individually adjusted by occupational therapists (control group).

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Key information

Conditions

Splints

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Klinik für Plastische, Rekonstruktive, Aesthetische und Handchirurgie,

Basel, 4035, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients presenting to the hand surgical department of the University Hospital Basel
  • Patients with hand trauma w/wo the need for hand surgery or patient with planned elective hand surgical intervention
  • Indication for immobilization of at least 4 weeks
  • Older than 18 years
  • Capable of consent
  • Informed Consent as documented by signature

Exclusion criteria

  • Open wounds with tissue loss
  • Injury with the need for external fixation
  • Younger than 18 years
  • Not capable of consent
  • Asymmetric deformity or loss of the contra-lateral hand
  • Documented hypersensitivity or allergy to Polylactic acid
  • Known or suspected non-compliance to agreed treatment measures and/or unexcused nonappearance to hospital appointments
  • Drug or alcohol abuse
  • Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
  • Previous enrolment into the current study

Treatment and study plan

3D printed splints

Device

3D printed made to measure splints

Thermoplastic splints

Device

thermoplastic splints individually adjusted by occupational therapists

Primary outcomes

  1. Change in patient comfort and satisfaction

    Time frame: at 2-5 days after trauma and/or surgery

    questionnaire 1. that will be filled out by the Patient (scale 1-10 and answer text with qualitative assessment)

  2. Change in patient comfort and satisfaction

    Time frame: at 2 weeks of immobilization during a routine control visit

    questionnaire 2. that will be filled out by the Patient (scale 1-10 and answer text with qualitative assessment)

  3. Change in patient comfort and satisfaction

    Time frame: at 6 weeks of immobilization during what is usually the concluding visit of treatment

    questionnaire 3. that will be filled out by the Patient (scale 1-10 and answer text with qualitative assessment)

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

3D Printed Made to Measure Splints for Hand Patients - Pilot Feasibility Study and Socioeconomic Evaluation

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Mar 13, 2020
Registry last updated
Jun 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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