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

Study Overview
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Brief Summary
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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 dorsally displaced distal radius fracture (AO type 23-A-C) that is acceptably reduced. In both parts, participants should have no restrictions in activities of daily living pre-fracture and no evident anatomical difference between both wrists. Intervention: Part 1: Participants will wear the brace continuously for one week. Part 2: Participants will wear the brace as treatment of the fracture for five weeks (instead of a plaster cast). Main study parameters/endpoints: In parts 1 and 2, the primary outcome measure will be a Visual Analog Scale (VAS) score for wearing comfort. Secondary outcome measures are the occurrence of fracture redislocation (part 2 only), pain (VAS), inconvenience during NL61002.078.17 / DRFB-Tolerability Distal Radius Fracture Brace Tolerability Version number: 1.1, d.d. April 24, 2017 8 of 34 activities of daily living (Katz Index), and adverse reactions like pain, skin pressure, skin irritation/redness, sensibility issues, or device-related problems.

Detailed Description
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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.

Official Title
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Nonoperative Treatment of Dorsally Dislocated Distal Radius Fractures in Adults With an Individualized 3D Printed Brace; a Tolerability Study in Healthy Volunteers and Patients (DRFB)

Conditions
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Dorsal Displacement

Intervention / Treatment
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* Device: Distal radius fracture brace


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two consecutive prospective case series to investigate brace feasibility.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healthy volunteers<br>All volunteers wore the DRFB | Device: Distal radius fracture brace<br>* The distal radius fracture brace is constructed from biocompatible materials (like polylactic acid; PLA) and the skin is protected by commercially available and approved waterproof padding (like Aquacast®). The major brace components are connected and reinforced with carbon rods and plastic bolt-nut connections. PLA is extensively used, for example in surgical implants, but also as biological alternative for plastics. Aquacast® is approved and used as waterproof padding in swim plaster. The biomechanical function of the distal radius brace has been tested successfully in an ex vivo setting (results to be published). The DRFB includes the distal forearm, wrist an base of the hand. The thumb and fingers are free and the DRFB provides more movement than classical casting.<br>|
| Experimental: Patients with DRF<br>All patients wore the DRFB | Device: Distal radius fracture brace<br>* The distal radius fracture brace is constructed from biocompatible materials (like polylactic acid; PLA) and the skin is protected by commercially available and approved waterproof padding (like Aquacast®). The major brace components are connected and reinforced with carbon rods and plastic bolt-nut connections. PLA is extensively used, for example in surgical implants, but also as biological alternative for plastics. Aquacast® is approved and used as waterproof padding in swim plaster. The biomechanical function of the distal radius brace has been tested successfully in an ex vivo setting (results to be published). The DRFB includes the distal forearm, wrist an base of the hand. The thumb and fingers are free and the DRFB provides more movement than classical casting.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS score | the primary outcome measure will be the change in 1 week (part 1) and over several weeks (part 2) on a 10-centimeter Visual Analog Scale (VAS) score for wearing comfort, in which 0 implies no comfort. and 10 implies extremely comfortable. | Day 1, day 3 and 7 for part 1. Week 1, week 2 and week 5 for part 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Redislocation | Redislocation is determined by the radiologic outcome: Dorsal tilt > 15˚ on lateral X-ray Volar tilt >20˚ on lateral X-ray Shortening >5mm pertaining to the ulna in PA direction Intraarticular step-off ≥ 2mm Radial inclination < 15˚ in PA direction Subluxation of the lunate According to guidelines on these parameters, redislocation is diagnosed. | Week 1, week 2 and week 5 (only part 2) | 
| Pain Level | Pain level caused by the brace will be determined using a 10-centimeter Visual Analog Scale (VAS), in which 0 implies no pain and 10 implies the worst possible pain. | Day 1, day 3 and 7 for part 1. Week 1, week 2 and week 5 for part 2 | 
| Inconvenience | Inconvenience during activities of daily living using the Katz Index. The Katz Index asks for limitations in washing, clothing, indoor transfers, toilet visit, continence and eating. The range for the Katz index is 0 to 6 where 6 indicates full function, 4 indicates moderate impairment and 2 or less indicates severe functional impairment. | Day 1, day 3 and 7 for part 1. Week 1, week 2 and week 5 for part 2 | 
| Adverse reactions (pain, skin pressure, skin irritation/redness, sensibility issues or device-related problems | Adverse reactions like pain, skin pressure, skin irritation/redness, sensibility issues, or device-related problems. | Day 1, day 3 and 7 for part 1. Week 1, week 2 and week 5 for part 2 |