The main objective of this study 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 splints as compared to a control cohort.
ID
Source
Brief title
Condition
- Fractures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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
Background summary
The standard conservative treatment for distal radius fractures 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. Patient specific 3D-printed splints may be a viable alternative to
conventional casts. We hypothesize that personalized 3D-printed splints result
in improved outcomes on patient reported outcome measures.
Study objective
The main objective of this study 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 splints as compared to a control cohort.
Study design
A single centre cross-cohort study
Study burden and risks
Participants may benefit in the form of better ventilation, less perspiration,
less warmness and ability to perform water related activities such as showering
and swimming compared to the standard of care. The results from the study will
provide new insights into feasibility and effectivity of patient specific
3D-printed splints in the treatment of DRF*s. We would like to investigate
whether the use of personalized 3D-printed splints leads to higher patient
satisfaction compared to treatment with conventional forearm casts.
We expect none or only minimal adverse effects from the 3D-printed splint
intervention. We assume that healing rates are similar. However, potential
risks are breakage of the 3D-printed splint or allergic reaction the resin
used. Besides the utmost care taken in the design and production process to
prevent this, the potential risks could include damage of the underlying skin.
Treatment can be continued with a conventional forearm cast. Therefore, we
assume the risk is minimal.
Other burdens for participants associated with this study is related to
measurements of endpoints. Patients need to fill in one questionnaire directly
after immobilization one week post injury and five (short) questionnaires
directly after the removal of the 3D splint. Filling out the questionnaire
directly after immobilization will take approximately 5-10 minutes. The
questionnaires will take approximately 25-30 minutes to fill out directly after
removal of the 3D-printed splint. Moreover, after removal pictures of the
affected forearm will be made and participants answer questions in a
semi-structured interview. The interview will take an additional 10-15 minutes.
Patients may be called by the investigator for further clarification when a
questionnaire is incomplete. Patients are not required to visit the Radboudumc
more than required for the standard of care DRF*s. Informed consent is needed
to include patients for the study and get access to the medical files.
Outside the scope of this study: the use of patient-specific 3D-printed splints
seems to result in a lot less waste products. This assumption will be
investigated in different studies such as a life cycle assessment.
Geert Grooteplein 10
Nijmgen 6525 GA
NL
Geert Grooteplein 10
Nijmgen 6525 GA
NL
Listed location countries
Age
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
•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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL83500.091.22 |