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

Erasmus MC, Universitair Medisch Centrum Rotterdam0 个研究点目标入组 20 人开始时间: 待定最近更新: 2024年2月28日

试验速览

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•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.

•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).

发起方