fraccture injury
Conditions
Interventions
None listed
Sponsors
Radboud Universitair Medisch Centrum
Eligibility
Age
16 Years to 99 Years
Inclusion criteria
Inclusion criteria: •Age 16 years or older •Admitted to the emergency department or plaster room with a DRF •Non-operative treatment with cast immobilisation •Written informed consent •Patients must be able to follow the study protocol
Exclusion criteria
Exclusion criteria: •Operative treatment •Open fractures •History of surgically treated wrist fracture on the currently injured side •Unable to wear conventional forearm cast or splint due to medical condition, known allergies or other reasons. •(partially) paralysis of the affected limb •DRF older than two weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 (issues discussed: limitations daily life, cosmetic look, local complications) and quantitively using questionnaires. Questionnaires: • Patient Reported Wrist Evaluation (PRWE) - measure of patient rated pain and disability for wrist conditions. •D-QUEST - instrument for measuring client satisfaction with a medical device. D-Quest is a Dutch version of the Quebec User Evaluation of Satisfaction with assistive Technology. •CSD-OPUS - The orthotics and Prosthetics User*s Survey (OPUS) on the Satisfaction with Devices (CSD). •EQ-5D VAS - Rates the overall health of a patient. | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical outcomes: - Complications. The McKay checklist will be used for scoring the complications after a DRF. - Union rate will be measured according to the current clinical standard. The treatment will be considered sufficient if the bone is capable of undergoing the tasks it was capable of before the fracture. Safety outcomes: - Reasons for withdrawal. - Adverse events (production- and wearing of the 3D-printed splints). Barriers to implementation: - Acceptance by caregivers - Technical problems related to hardware used in the 3D workflow | — |
Countries
Netherlands
Outcome results
None listed