Nonoperative Treatment of Dorsally Dislocated Distal Radius Fractures in Adults With an Individualized 3D Printed Brace.

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 closed reduction and nonoperative treatment by immobilization in a plaster cast for 4-6 weeks. Surgery is only performed if closed reduction fails or redislocation occurs. Plaster immobilization is inconvenient and interferes with daily activities. More importantly, standard nonoperative treatment often fails; in 40-60% of the fractures, redislocation requires surgery. Surgical treatment is about 9 times more expensive than nonoperative treatment and not without risks. This project aims to develop an innovative nonoperative treatment option. The central idea is to produce a 3D-printed brace for the fractured wrist using a mirrored CT-scan of the contralateral, unfractured wrist as a model. This innovative approach has the advantage that it does not depend on surgery and provides a better and potentially more durable positioning than the currently applied plaster cast. We expect that redislocation will occur less frequently, so surgery may be avoided. In contrast to a traditional plaster cast, the newly developed brace is water resistant/repellant, lighter, and enables movement of the hand. It enables daily activities and improves independency in the elderly with a wrist fracture. The treatment has been successfully evaluated in an ex vivo model. The clinical implementation will follow a step-wise approach.

Objective: Part 1 aims to determine the tolerability of the 3D-printed brace when worn by healthy volunteers (50 years of order), performing their normal daily activities. In part 2, the objective is to determine tolerability of the 3D-printed brace in patients (50 years or older) with an extra-articular distal radius fracture with dorsal displacement, performing their normal daily activities.

Inclusion criteria

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 criteria

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).