An interventional study of Distal radius fracture brace in Dorsal Displacement, sponsored by VieCuri Medical Centre. Completed at 1 site in Netherlands. Open to participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-02-22.
Sponsored by VieCuri Medical Centre · Not applicable, Interventional, and Other
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.
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.
272 studies on the registry are indexed under Radius Fractures; 35 are open to participants now.
This study's enrollment of 15 is below the median of 60 across 218 interventional studies indexed under Radius Fractures.
Browse Radius Fractures studies →VieCuri Medical Centre is the lead sponsor of 15 studies on the registry; 1 is open to participants now.
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Part 1:
Part 2:
Signed informed consent by patient
Exclusion Criteria:
Part 1:
Part 2:
All volunteers wore the DRFB
Device: Distal radius fracture brace
All patients wore the DRFB
Device: Distal radius fracture brace
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.
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.
Time frame: Day 1, day 3 and 7 for part 1. Week 1, week 2 and week 5 for part 2
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Day 1, day 3 and 7 for part 1. Week 1, week 2 and week 5 for part 2
Age (calculated from date of birth and date of enrolment)
- Age (calculated from date of birth and date of enrolment)
Time frame: At baseline
Gender
- Gender (male or female)
Time frame: At baseline
ASA class
- ASA class (1, 2, 3 of 4), assessed in a face-to-face interview
Time frame: At baseline
BMI (calculated from height and weight)
- BMI (calculated from height and weight)
Time frame: At baseline
Tobacco consumption
- Tobacco consumption (current, ever, never) was assessed in a short face-to-face interview
Time frame: At baseline
Alcohol consumption
- Alcohol consumption at enrolment (yes or no), assessed in a face-to-face interview
Time frame: At baseline
Comorbidities including osteoporosis
- Comorbidities including osteoporosis were assessed from the electronic patients dossiers
Time frame: At baseline
Medication use
Medication use was assessed through the electronic patient dossiers
Time frame: At baseline
Dominant side (left or right)
Dominant side was assessed in a face-to-face interview
Time frame: At baseline
Affected side (part 2 only)
- Affected side (left or right) was assessed by the clinician
Time frame: At baseline
Trauma mechanism (low energy/high energy trauma or unknown)
- Trauma mechanism (low energy fall or other, high energy trauma, or unknown) was assessed through face-to-face interview
Time frame: At baseline
Additional injuries (yes or no, with specification)
Additional injuries were assessed in a face-to-face interview * Trauma mechanism (low energy fall or other, high energy trauma, or unknown) * Additional injuries (yes or no, with specification) * Fracture classification (AO type 23-A, B or C)
Time frame: At baseline
Fracture classification (AO type 23-A, B or C)
- Fracture classification (AO type 23-A, B or C) was diagnosed by the clinician
Time frame: At baseline
Date of scanning
Date of scanning was documented by the clinician
Time frame: At baseline
Date of brace fitting
Date of brace fitting was documented by the clinician.
Time frame: At baseline
Date of brace removal
Date of brace removal was documented by the clinician. If brace was removed early, it was documented how treatment was continued (in patients only).
Time frame: At baseline
Adherence to intervention
Adherence to the intervention was checked (yes/no) and reasons for not adhering were documented by the clinician
Time frame: At baseline
Plan to share: No
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