Clinical trial NCT03848702: Nonoperative Treatment of Dorsally Dislocated Distal Radius Fractures in Adults With an Individualized 3D Printed Brace.
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dorsal Displacement
Lead sponsor: VieCuri Medical Centre
Sponsor class: OTHER
Collaborators: name: Erasmus Medical Center
First posted: 2019-02-21
Enrollment: 15
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two consecutive prospective case series to investigate brace feasibility.
Primary purpose: OTHER

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 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: 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.

Eligibility criteria: Inclusion Criteria:

Part 1:

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 \* Participant should exercises complete self-control over urination and defecation, but use of incontinence material is allowed.

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.

Exclusion Criteria:

Part 1:

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 or 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).

Primary outcomes:
measure: VAS score
timeFrame: Day 1, day 3 and 7 for part 1. Week 1, week 2 and week 5 for part 2
Secondary outcomes:
measure: Redislocation
timeFrame: Week 1, week 2 and week 5 (only part 2)
measure: Pain Level
timeFrame: Day 1, day 3 and 7 for part 1. Week 1, week 2 and week 5 for part 2
measure: Inconvenience
timeFrame: Day 1, day 3 and 7 for part 1. Week 1, week 2 and week 5 for part 2
measure: Adverse reactions (pain, skin pressure, skin irritation/redness, sensibility issues or device-related problems
timeFrame: Day 1, day 3 and 7 for part 1. Week 1, week 2 and week 5 for part 2
Other outcomes:
measure: Age (calculated from date of birth and date of enrolment)
timeFrame: At baseline
measure: Gender
timeFrame: At baseline
measure: ASA class
timeFrame: At baseline
measure: BMI (calculated from height and weight)
timeFrame: At baseline
measure: Tobacco consumption
timeFrame: At baseline
measure: Alcohol consumption
timeFrame: At baseline
measure: Comorbidities including osteoporosis
timeFrame: At baseline
measure: Medication use
timeFrame: At baseline
measure: Dominant side (left or right)
timeFrame: At baseline
measure: Affected side (part 2 only)
timeFrame: At baseline
measure: Trauma mechanism (low energy/high energy trauma or unknown)
timeFrame: At baseline
measure: Additional injuries (yes or no, with specification)
timeFrame: At baseline
measure: Fracture classification (AO type 23-A, B or C)
timeFrame: At baseline
measure: Date of scanning
timeFrame: At baseline
measure: Date of brace fitting
timeFrame: At baseline
measure: Date of brace removal
timeFrame: At baseline
measure: Adherence to intervention
timeFrame: At baseline
Locations:
city: Venlo
country: Netherlands
facility: VieCuri MC
state: Limburg
Study officials:
References:
citation: Janzing HMJ, Bessems SAM, Ligthart MAP, Van Lieshout EMM, Theeuwes HP, Barten DG, Verhofstad MHJ. Treatment of dorsally dislocated distal radius fractures with individualized 3D printed bracing: an exploratory study. 3D Print Med. 2020 Aug 18;6(1):22. doi: 10.1186/s41205-020-00075-4.