onoperative treatment of dorsally dislocated distal radius fractures in adults with an individualized 3D printed brace; a tolerability study in healthy volunteers and patients

Completed

• Conditions: Distal radius fracture; wrist fracture; 10017322

• Registration Number: NL-OMON45464
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

Part 1:
1. Age 50 years or older
2. Healthy volunteer without distal radius fracture
3. No restrictions in activities of daily living prior to enrolment*
4. Signed informed consent by participant;Part 2:
1. Patients (50 years or older) with an acute**, unilateral distal radius fracture with dorsal displacement (AO type 23-A, B, or C) that is acceptably reduced (by simple closed reduction with vertical longitudinal traction)
2. No restrictions in activities of daily living pre-fracture*
3. Signed informed consent by patient;* Participant should exercises complete self-control over urination and defecation, but use of incontinence material is allowed.
** Patients should report to the Emergency Department within 48h post-trauma.

Exclusion Criteria

Part 1:
1. Preexisting anatomical deviation of the ipsi- or contralateral wrist
2. Conditions that affect function of the wrist or hand
3. Insufficient comprehension of the Dutch language to understand the study documents
4. Participant unwilling or unable to comply with the study protocol and follow-up visit schedule
5. Known allergy for brace material (PLA or alternative);Part 2:
1. Preexisting anatomical deviation of the ipsi- or contralateral wrist
2. Additional traumatic injuries that affect treatment, rehabilitation, or function of the affected hand
3. Pathological, recurrent, or open fracture
4. Impaired wrist function pre-trauma at either wrist (e.g., arthrosis, rheumatoid disorder, or neurological disorder)
5. Bone disorder that may impair bone healing, excluding osteoporosis
6. Patient unwilling or unable to comply with the treatment protocol and follow-up visit schedule
7. Insufficient comprehension of the Dutch language to understand the study documents
8. Known allergy for brace material (PLA or alternative).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Visual Analog Scale (VAS) score for wearing comfort. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Fracture redislocation (part 2 only)<br /><br>Pain (VAS)<br /><br>Inconvenience during activities of daily living (Katz Index)<br /><br>Adverse reactions like pain, skin pressure, skin irritation/redness,<br /><br>sensibility issues, or device-related problems. </p><br>