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

Primary Purpose

Dorsal Displacement

Status

Completed

Phase

Not Applicable

Locations

Netherlands

Study Type

Interventional

Intervention

Distal radius fracture brace

About this trial

This is an interventional other trial for Dorsal Displacement

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

VieCuri MC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Healthy volunteers

Patients with DRF

Arm Description

All volunteers wore the DRFB

All patients wore the DRFB

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

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.

Full Information

NCT ID

NCT03848702

First Posted

February 13, 2019

Last Updated

February 20, 2019

Sponsor

VieCuri Medical Centre

Collaborators

Erasmus Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT03848702

Brief Title

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

2. Study Status

Record Verification Date

February 2019

Overall Recruitment Status

Completed

Study Start Date

July 1, 2017 (Actual)

Primary Completion Date

June 1, 2018 (Actual)

Study Completion Date

July 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

VieCuri Medical Centre

Collaborators

Erasmus Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dorsal Displacement

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Two consecutive prospective case series to investigate brace feasibility.

Masking

ParticipantCare Provider

Masking Description

For part 1, a randomization list will be generated using an online program. For the 10 participants, five braces will be developed for the dominant side and five for the nondominant side. The physician and participant will be concealed for allocated side until the scan will be made.

Allocation

Randomized

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Healthy volunteers

Arm Type

Experimental

Arm Description

All volunteers wore the DRFB

Arm Title

Patients with DRF

Arm Type

Experimental

Arm Description

All patients wore the DRFB

Intervention Type

Device

Intervention Name(s)

Distal radius fracture brace

Intervention Description

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.

Primary Outcome Measure Information:

Title

VAS score

Description

Time Frame

Day 1, day 3 and 7 for part 1. Week 1, week 2 and week 5 for part 2

Secondary Outcome Measure Information:

Title

Redislocation

Description

Time Frame

Week 1, week 2 and week 5 (only part 2)

Title

Pain Level

Description

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

Title

Inconvenience

Description

Time Frame

Day 1, day 3 and 7 for part 1. Week 1, week 2 and week 5 for part 2

Title

Adverse reactions (pain, skin pressure, skin irritation/redness, sensibility issues or device-related problems

Description

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

Other Pre-specified Outcome Measures:

Title

Age (calculated from date of birth and date of enrolment)

Description

- Age (calculated from date of birth and date of enrolment)

Time Frame

At baseline

Title

Gender

Description

- Gender (male or female)

Time Frame

At baseline

Title

ASA class

Description

- ASA class (1, 2, 3 of 4), assessed in a face-to-face interview

Time Frame

At baseline

Title

BMI (calculated from height and weight)

Description

- BMI (calculated from height and weight)

Time Frame

At baseline

Title

Tobacco consumption

Description

- Tobacco consumption (current, ever, never) was assessed in a short face-to-face interview

Time Frame

At baseline

Title

Alcohol consumption

Description

- Alcohol consumption at enrolment (yes or no), assessed in a face-to-face interview

Time Frame

At baseline

Title

Comorbidities including osteoporosis

Description

- Comorbidities including osteoporosis were assessed from the electronic patients dossiers

Time Frame

At baseline

Title

Medication use

Description

Medication use was assessed through the electronic patient dossiers

Time Frame

At baseline

Title

Dominant side (left or right)

Description

Dominant side was assessed in a face-to-face interview

Time Frame

At baseline

Title

Affected side (part 2 only)

Description

- Affected side (left or right) was assessed by the clinician

Time Frame

At baseline

Title

Trauma mechanism (low energy/high energy trauma or unknown)

Description

- Trauma mechanism (low energy fall or other, high energy trauma, or unknown) was assessed through face-to-face interview

Time Frame

At baseline

Title

Additional injuries (yes or no, with specification)

Description

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

Title

Fracture classification (AO type 23-A, B or C)

Description

- Fracture classification (AO type 23-A, B or C) was diagnosed by the clinician

Time Frame

At baseline

Title

Date of scanning

Description

Date of scanning was documented by the clinician

Time Frame

At baseline

Title

Date of brace fitting

Description

Date of brace fitting was documented by the clinician.

Time Frame

At baseline

Title

Date of brace removal

Description

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

Title

Adherence to intervention

Description

Adherence to the intervention was checked (yes/no) and reasons for not adhering were documented by the clinician

Time Frame

At baseline

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

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).

Facility Information:

Facility Name

VieCuri MC

City

Venlo

State/Province

Limburg

ZIP/Postal Code

5912 BL

Country

Netherlands

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

32809083

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.

Results Reference

derived

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

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