Status:
COMPLETED
Nonoperative Treatment of Dorsally Dislocated Distal Radius Fractures in Adults With an Individualized 3D Printed Brace.
Lead Sponsor:
VieCuri Medical Centre
Collaborating Sponsors:
Erasmus Medical Center
Conditions:
Dorsal Displacement
Eligibility:
All Genders
50+ years
Phase:
NA
Brief Summary
Study design: Two consecutive prospective case series. Study population: Part 1 will enroll 10 healthy volunteers (50 years or older). Part 2 will enroll 10 elderly patients (50 years or older) with a...
Detailed Description
Rationale: Each year, approximately 34,500 adults in The Netherlands sustain a fracture of the distal radius (wrist fracture). Incidence peaks in the elderly. The currently preferred treatment is clos...
Eligibility Criteria
Inclusion
- Part 1:
- Age 50 years or older
- Healthy volunteer without distal radius fracture
- No restrictions in activities of daily living prior to enrolment\*
- Signed informed consent by participant \* Participant should exercises complete self-control over urination and defecation, but use of incontinence material is allowed.
- Part 2:
- 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)
- No restrictions in activities of daily living pre-fracture\*
- 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
- Part 1:
- Preexisting anatomical deviation of the ipsi- or contralateral wrist
- Conditions that affect function of the wrist or hand
- Insufficient comprehension of the Dutch or language to understand the study documents
- Participant unwilling or unable to comply with the study protocol and follow-up visit schedule
- Known allergy for brace material (PLA or alternative)
- Part 2:
- Preexisting anatomical deviation of the ipsi- or contralateral wrist
- Additional traumatic injuries that affect treatment, rehabilitation, or function of the affected hand
- Pathological, recurrent, or open fracture
- Impaired wrist function pre-trauma at either wrist (e.g., arthrosis, rheumatoid disorder, or neurological disorder)
- Bone disorder that may impair bone healing, excluding osteoporosis
- Patient unwilling or unable to comply with the treatment protocol and follow-up visit schedule
- Insufficient comprehension of the Dutch language to understand the study documents
- Known allergy for brace material (PLA or alternative).
Key Trial Info
Start Date :
July 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2018
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT03848702
Start Date
July 1 2017
End Date
July 1 2018
Last Update
February 22 2019
Active Locations (1)
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1
VieCuri MC
Venlo, Limburg, Netherlands, 5912 BL